Economist, why so pessimistic about open source medical devices software?

I read an interesting article in the Economist’s Technology Quarterly of June 2nd-8th of 2012, p. 17-18, on open source medical devices software. Let me summarise for you: the article starts by showing all the benefits of medical devices software that is developed using open source models, and there are many. For example, security of high risk medical devices that might be hacked at a distance to be used against the patient could be much improved if many creative minds with different points of view work collaboratively on software for devices.

The article concludes however that open source has no place in the current regulatory environment and points only to FDA regulation for that conclusion. It quotes a pessimistic open source protagonist who states it is impossible to get open source through the regulatory process but that “It may even happen (…) in parts of the world where strict regulation does not exist.” I would rephrase: where inflexible regulation does not exist. As you know, I am an outspoken protagonist of the European CE system because I am a believer in its flexibility and have defended this against attacks to the effect that it would result in unsafe devices entering the market, for example here, here and here. In my view, the EU CE system is actually ideal for delivering open source software to the devices market, without compromising on safety or regulatory rigour in the least.

But first, why does the Economist assume that currently no open source is used in the manufacturers’ own closed systems? That is a big misconception. Manufacturers often do not even code their own software themselves entirely but often outsource that almost entirely. The most efficient way to build software is to use well established open source elements for standard operations and that is how even the most closedly developed device software is built, whether by manufacturers themselves or the aprties to whom they outsource. So, open source is in approved proprietary software already. I have evaluated many critical software systems in due diligence that were dependent on open source elements for their safe and effective operation, and that is perfectly OK because open source software is not necessarily bad software. Often it is even better.

So back to the CE system. Crucial to the manufacturer’s burden to prove the claimed safety and performance is risk management as part of the software design, among others using the EN 62304 standard. Risk management is a rational and transparent process that can very well include rationales about why it is better to use open source modules or code instead of home coded. Especially where a manufacturer can document that open source has a long standing development history, this may well make the use of open source preferable to proprietary code in terms of risk management. In addition, open source would be a plus from a clinical evaluation perspective. In the EU system the manufacturer must apply a cyclical process to keep validating its device to the state of the art, called clinical evaluation. If you use open source software that stems from an active community, you suddenly have a lot of free extra eyes assisting you in that process and helping you to improve the software. The only setback – for some – would be that an open source community normally asks that you share your improvements too and manufacturers are ot always willing to do that.

One caveat with open source that I see are the regulatory obligations of the manufacturer with respect to corrective action. It is obviously a lot more difficult to unilaterally make corrections to open source software as a corrective action in response to an incident. On the other hand, if a manufacturer is actively engaged in the developer community for that open source software, implementing corrective action may even go faster because everybody has an interest to make the code better. Such problems can be remedied also to an extent by using open source only for modules that could be replaced by other ones as a plan B. Furthermore, you have to be mindful of the license for the use of the open source software. There are copyleft and viral license models out there in the market that are very unattractive to use from a legal perspective.

So, to conclude: I do not share this pessimistic view about missed opportunities and insurmountable legal barriers for open source in devices at all for the EU system. Of course, you may need to rationalise why the use of open source software in a given case is a good idea, but you also have to manage risks for own developed software. It may actually be easier in some cases to show that existing open source software is more robust than what you could hope to develop in-house. Theoretically that means that for the EU there is no additional regulatory burden. The only burden I could imagine would be regulator or notified body bias that open source software is inherently less safe than own developed software. That type of bias is not justified as it is not evidence based and can be challenged.

I can readily envisage manufacturer supported open source communities for medical devics software that address all of the risks I mentioned and actually support the development of shared standards rendering the devices more interoperable as more manufacturers join a particular open source initiative. That would actually lead to safer and more effective devices. And it’s allowed in Europe.

CE marking, eHealth, Notified Body, Software

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11/06/2012

3 Comments

EU court AG concludes in borderline case – “intended use by nature”?

The Advocate General of the EU Court presented his conclusion today in one of the three medical devices borderline cases currently pending at the EU Court, C-219/11 Brain Products vs BioSemi. The other two are C-109/12 Lycocentre and C-308/11 Chemische Fabrik Kreussler, with respect to the latter see also here. The other two are more interesting as far as I am concerned as they address the demarcation vis-a-vis directive 2001/83, the medicinal products directive, and an interesting question about the possibility for national authorities to qualify products differently for regulatory purposes in C-109/12 Lycocentre. So if you ask me, these are the two to watch for the moment.

But let’s look at Brain Products. This case concerned the question “Does a product which is intended by the manufacturer to be applied for human beings for the purpose of investigation of a physiological process constitute a medical device, within the terms of the third indent of Article 1(2)(a) of Directive 93/42/EEC, only in the case where it is intended for a medical purpose?”. The question was raised in a court case about a device that the manufacturer did not intend for medical use:

“This is a system capable of recording electrical signals from the human body and, more specifically, from the brain (EEG), the heart (ECG) and the muscles (EMG). Although measurements of that nature are frequently taken in a healthcare context (using electrocardiograms, electroencephalograms and so on), the product in question is not designed for the medical sector and the related promotional material explicitly states that it is not designed to be used for diagnosis and/or treatment. The primary users of ActiveTwo, which is modular and can therefore be configured to meet the needs of individual customers, are researchers carrying out investigations, particularly in the cognitive sciences.”

Brain Products sued manufacturer BioSemi alleging that, regardless of its intended use, the system manufactured by BioSemi must be regarded as a medical device for the purposes of the directive and, accordingly, must be certified as such.

To summarise the long and winding argument of the AG: it’s the intended purpose of the manufacturer that determines if something is a medical device, not the purpose others may give to the device. The AG solves the problem by demonstrating teleologically why the scope of the medical devices directive is and was always determined by the overarching requirement of intent of medical use by the manufacturer (as the Commission set out in MEDDEV2.1/1 from 1994, the very first guidance document on the medical devices directive). To demonstrate this, the AG referes to ‘dual use’ products such as software and toothbrushes to show that the medical intended purpose determines the scope of the directive in relation to a product.

There is one Easter egg in the conclusion, in point 63, which concerns a question that is often asked in relation to obvious borderline products with a big disclaimer on them theat they are not intended for medical use even if they are clearly so intended, like many iPhone and iPad apps:

“Even if the information provided by the manufacturer is the key factor in determining whether a product is intended to be used for a medical purpose, any product which, by its very nature, is clearly intended to be used solely for a purpose of a medical nature will have to be regarded as a medical device, even if the manufacturer does not describe it as such. In any event, that proviso, which is designed to prevent abuse, ought not to be needed in most cases, since – including for obvious reasons of professional liability – the consistent practice of medical structures is to purchase only products which have been certified in accordance with the directive.”

This is something, as I have debated my theory with cheeky app developers who were not convinced about my answer that you cannot disclaim an obvious intended purpose as this would amount to a contradictory label and consequently an non-compliant product. The AG uses an even shorter punch: you cannot disclaim obvious intended purpose by nature. I am not sure if this is the best way to deal with this problem, as the “obviousness” of intended purpose may be difficult to establish especially in the case the manufacturer does not describe it on the label or other materials. Like Mr Jaggers in Dickens Great Expectations I prefer to rely on facts (“Take nothing on its looks; take everything on evidence. There’s no better rule.”). Imputing an “intended use by nature” that is not described is a challenge from an evidence perspective to say the least. Although I agree with his conclusion on the law I think AG Mengozzi is overshooting his target here.

I don’t expect the Court’s judgment to provide big surprises either. Just like we have seen and expect with other borderline cases, the Court will limit itself to formulating a legal criterion that may not always be very helpful in the light of the facts of the case because the Court is not allowed to do the work of the national court. But we’ll know in a couple of months when the Court hands down its judgment.

Borderline, CE marking

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15/05/2012

4 Comments

EU ENVI Parliamentary Committee resolution re Review : “learn the lessons of this fraud” and an FDA internal report

The European Parliament’s ENVI Committee (Committee on the Environment, Public Health and Food Safety) has added to the political pressure on the European Commission that is currently working on the proposal of the Review of the medical devices directives, still scheduled for the end of Q2 2012 as far as I know. At its meeting on 25 April is unanimously passed a resolution requesting the Commission to implement among other things in the words of the press release:

A breast implant register, more stringent checks and product traceability, and a premarket authorisation system are among the measures proposed by the Environment and Public Health Committee on Wednesday to prevent a recurrence of the PIP defective breast implants case.

Goals of the ENVI resolution are (in the words of the press release):

  • “Market surveillance, vigilance and the functioning of notified bodies must be improved”
  • “increased traceability of implanted medical devices”
  • “increased coordination between Member States when it comes to reporting and warning about serious side effects or damage done”
  • “patients’ associations, patient groups and health care professionals must be encouraged to report all adverse events and harmful effects of these devices without being hampered by a great deal of red tape”
  • “shift to a pre-market authorisation system for certain medical devices”
  • “patients must be made aware of breast implant risks”
  • “introduction of an implant recipient’s passport, stating the implant’s specific characteristics and its potential adverse effects, and a breast implant register in each Member State”
  • “a system of collective redress should be put in place to help patients to obtain compensation”

What these proposals mean in detail can be seen in the last version of the amendments to the text, which I expect is the one approved (I could not locate the final approved text yet but this is the draft motion for a resolution that ENVI started out with). The Commission is not obliged to take all of this on board in its proposal at this stage, but this is a clear shot across the bow from Parliament telling the Commission what Parliament wants to see in the proposal if it is to have a chance to make it through Parliament. Parliament  can make life difficult on the Commission by killing or crippling its proposal with amendments the Commission won’t stand for or by not even agreeing with it. So this is a clear signal for the Commission of what Parliament expects from it in the proposal.

The resolution has been received with mixed feelings by the industry, as Eucomed reports in yesterday’s press release. On the face of it, the resolution’s goals are not a great departure from what the Commission was planning to do anyway, except for the pre-market authorisation for certain devices (plans for a collective redress system have been in the works for some time but are progressing slowly). My guess is that the Commission will stick to the current plan of not setting up a pre-market approval system, because there is no budget a) to create a new agency, b) to put it in the EMA (and how well are they really doing on the approval process of their recent addition ATMPs in the first place?) or c) to task member states with it in a decentralised way because they have no budget because they don’t even have budget for market surveillance. The Commission will have to look for other ways to appease the Parliament on this point and guide its proposal through.

It’s a pity that the Commission’s well thought out plans have been caught up by a scandal that everybody recognises could not have been prevented by rules alone, but still causes the rules themselves to be blamed. I think the only party that took the right action here was Commissionar Dalli with the request to member states to take vigilance seriously. Everyone is blaming Europe while the problem really is lack of decentralised follow-up and lack of commitment from the member states. This cannot be fixed except with the member states stepping up and committing more resources, whether or not in a centralised fashion. For that reason everyone should not look at the Commission only, but also look at the member states (as the resolution does – to give it credit – it repeatedly “urges the Member States” to take actions; they have the power in the European Council that votes on the draft regulation later on to step up efforts on a national level). I hear back from Dutch sources at the Danish Presidency that a non-paper has been drafted at the meeting of the Council of Ministers of Health on 23-24 April 2012  to address crisis management for medical devices and the role of the Health Security Committee (in Dutch) and the Dutch Minister of Health spoke out with a proposal that includes starting to speak the same language in market surveillance.

Anyway, and then there is this “lambasting” internal report of the FDA saying that the EU devices market approval system is ineffective that is bound to create some additional pressure (full text here). I hear from my sources that the European Commission was not happy with this report at all and that it does not help with maintaining good EU-US relations. Nor am I happy with it. Apart from it being wrong and/or inaccurate on the law on points, which we have seen before with crititcs of the EU system time and time again, it looks looks to me like a textbook ‘wag the dog’ exercise to distract everyone from the FDA’s own problems with the present criticism accusing the FDA market approval system to be less-than-perfect. The argument used in the report is built up in the way that smokers often defend that smoking is not unhealthy: you point at case studies about 12 heavy smokers that  turned 80 in good health and then conclude that smoking cannot be unhealthy. This a a well known trick we lawyers use in litigation when we have no significant evidence but still need to make a point that looks like it is supported by evidence. With all due respect: for an agency that also looks at whether clinical studies for devices stick together correctly statistically I would have expected more sophistication to support the sweeping conclusions in the report. “Seek first to understand, then to be understood” if you want to make a point well, to quote a highly effective American, and: why can’t we all just get along?

FDA, Recast

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27/04/2012

6 Comments

Marketing surveillance shaping up pre-Review with Dutch Minister feedback to Dalli Action Plan

Interesting developments after the joint plan for action that Commissioner Dalli sent to the member states in the beginning of February this year urging them to step up market surveillance in order to safeguard the credibility of the EU medical devices vigilance system (which are conveniently summarised in his speech of 9 Febuary 2012): the Dutch minister of Health sent a public reply to the European Commission detailing what the Dutch government thinks should be done to make the system more effective and what the Dutch are willing to do.

The reply is noteworthy for a number of reasons. First of all, it addresses points that the Commission did not (explicitly) address in its letters to the member states about the joint action plan. Secondly, it gives an insight into what member states think is feasible and what should go into the Review. Feasibility is an important point here. I recently sat down with one of the vice presidents of regulatory of one of the biggest devices companies in the world and we calculated that under present circumstances EU member states devote about roughly a 100 times more resources to medical products oversight than to medical devices oversight. In other words: commit peanuts and, well, let’s say you don’t achieve an optimal result. Everyone can be outraged about scandals all they want, but this is where it all starts and ends; just like it did with medicinal products and their regulation that is touted to be the solution for all the problems of medical devices oversight by HCPs. Sure, if member states are willing to increase their medical devices oversight budgets by a factor 100 important improvements can be made easily.

So, what do the Dutch propose? Not factor 100 increase of budget, that is certain because no member state (nor the Commission) can afford that at the moment. They do propose some other things, some of which controversial but effective.

  1. Coordination. With regard to the further elaboration of some of the actions, the Dutch minister stresses the importance of Member States to act jointly and in a coordinated manner while implementing the proposed actions and adds that the Central Management Committee (CMC) could be of great added value in this process.
  2. Notified bodies. Dalli’s letter requested member states to critically review notified bodies and their accreditation, joint inspection teams were coined internally as possiblity and have found their way to the Review proposal. The Dutch add that ‘Joint Inspection Teams’ of Competent Authorities (CA’s) should be composed of inspectors of at least two member states. Inspections of Notified Bodies should take place partly unannounced. Nothing new so far but here it comes: “It is also crucial that inspection reports are written in English and filed in an EU-database, which has to be accessible to every Competent Authority.” The part on language is new and politically controversial as language always is. It goes without saying that using one language for reports or for that matter inter-authority communication has immense benefits. Different languages are provide cultural diversity but not effective communication if you want an integrated pan-EU market surveillance capability. Not that many member states will want to allow reporting to happen in another language than their own. The Dutch are less concerned about that, which makes them an excellent party to get the ball rolling here. It would be an immense benefit if authorities were to think beyond their immediate borders and use one language for this, and I personally don’t really care that much if that’s English, French or German. It would make things much easier.
  3. Market surveillance. Commissioner Dalli’s plan already requested that Competent Authorities should focus on manufacturing companies as a whole in their market surveillance (the action plan already indicates the need for inspection by the notified body of the specific product which is being assessed). Manufacturing companies that operate internationally should be inspected by Joint Inspection teams of at least two member states. New is the Dutch idea to organise EU coordinated market surveillance according to the complete life cycle of specific ‘product lines’. That would mean (I think) that the focus of supervision would be directed to the phases of the life cycle of device group and associated surveillance needs. For example, the most incidents tend to happen when a new group of devices hits the market. It will still need to become clear what this will look like exactly, but the fact that the Dutch government is talking about this publicly I think means that they are pushing to have this included in the Review. Also in respect of market surveillance the Dutch emphasize the need of inspection reports by the Competent Authorities and the audit reports from Notified Bodies to be  written in English and accessible to Competent Authorities in an EU-database.
  4. Registration of implants and its complications. Registration of implants and the registration of adverse events are essential to effective market surveillance including the detection of long-term implications and taking effective corrective actions at European level in case of serious incidents. The Dutch underlines that it is necessary to involve health care professionals and end-users, which is entirely true. In my practice I find time and time again that vigilance efforts are less than effective because HCPs are not that enthusiastic about cooperation for vigilance purposes for a multitude of reasons. At short notice the Netherlands intends to set up a working group to investigate the possibilities of such a registration in the Netherlands. The working group will also take into account other existing initiatives in the EU, which the Dutch hope will contribute to a European registration, of which we know that it will be included in the Review as the Commission is planning EU UDI for devices.
  5. Stricter Post Market Surveillance (PMS)- obligations of the manufacturer. The Dutch minister says that current Post Market Surveillance obligations could be stricter; manufacturers could be obliged in a stricter way to notify Vigilance reports to Notified Bodies directly and that  Post Market Surveillance activities and frequent reports to the Competent Authority should be a specific obligation as part of audits of manufacturers by Notified Bodies. The latter is fleshed out in more detail in the new MEDDEV on PMCF that I wrote about on this blog. As I predicted, this MEDDEV is a prelude to obligations that will become mandatory in the Review. Vigilance reporting to notified bodies is currently an internal contractual issues between the notified body and the manufacturer and I see notified bodies deal with this in varying degrees of diligence. Standardised rules on vigilance reporting to the notified bodies would in my view improve supervision, but they would on the other hand require a less cyclical (and more continuous) process at notified bodies, which not all of them will be able to facilitate. This should be firmer part of the accreditation requirements, which Commissioner Dalli has requested the member states to review.

So let’s see how this progresses – it does provide some insight where things are going and what the Review may look like in the proposed version that is still slated to come out June 2012, even if many doubt that. If readers of this blog are aware of reactions of other EU member states to the joint plan of Commissioner Dalli, I would be very interested in hearing about them.

Clinical evaluation, Notified Body, Vigilance

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23/04/2012

8 Comments

Everything you always wanted to know about stand alone software, but were afraid to ask

I hope you won’t mind me imposing on you with some more self promotion – it’s for your own good as this is about saving you money, both in the short run (if you register before 16 April you pay more than 50% less) and in the long term (well, you know what legal and/or regulatory advice costs if you have to engage it after the fact).

In cooperation with Norbert Sparrow of European Medical Device Technology (EMDT) I will seek to answer your every question about the recent stand alone software MEDDEV, data protection implications of stand alone software and what the current revision of EU medical devices directives may have in store for regulation of stand alone software as medical device, in a webcast on 24 April, for which you can register here.

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Uncategorized

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10/04/2012

6 Comments

The latest on the Recast, Review, Revision of EU medical devices framework

Whenever Ms Minor from DG SANCO speaks at an event, everyone in the medical devices industry listens, hoping for new elements about where the Commission is going with the recast, review or revision of the EU medical devices directives, however you want to call it in the mean time. I believe the term ‘revision’ is the one for the moment. Today she spoke at the DIA Euromeeting event in Copenhagen, and gave a nice overview of what the Commission presently intends and where it is at with the revision. I’ll try to point out new elements where I thought I noticed them and hope you will forgive me for the condensed language below (which is the price for outscooping the paid-for services).

A new theme is that the Commission looks to take measures also within the existing legal framework pending the Revision, which will take three years to complete at least. These are the measures requested from Commissioner Dalli from the member states recently.

Ms Minor underlined that the medical devices directives have a dual purpose: protect patents and ensure free movement. They have both a healthcare and commercial rationale, Minor emphasizes. The EU must remain innovation-friendly and competitive. The future system will have to accommodate for fact that most companies regulated are SMEs and deal with the increasing interface with pharmaceutical products, mainly with a view to combination products and companion diagnostics.

Theme of the revision will be to  build on the strengths and improve on the weaknesses of the current system. Its major strength is to maintain the delicate balance between pre- and post-market control that has served the EU very well but to ensure safe products entering market and detect issues timely and react.

There is change in expectations of the HCPs and patients compared to 20 years ago, challenges in aging population and health management of chronic diseases. The by now 20 year old system must be changed to account for this.

The Commission plans to adress in future regulation (summary compared against the last Ms Minor speech I visited at the RAPS end 2011):

Scope (nothing new) 

  • (non-viable cells gap and invasive cosmetic devices (cosmetic implants gap)
  • reprocessing of single use devices
  • “in house” tests – level playing field but some leeway for emergency tests
  • genetic tests for non-medical purposes
  • medical devices used for diagnostic services at a distance

Supervision of notified bodies (some newish)

  • Uniform practice for designation and monitoring of notified bodies (more detailed minimum requirements, pre-designation inspection by mixed teams of different member states and perhaps list of EU inspectors (this latter element is certainly newish))
  • uniform standards for conformity assessment (variation in diligence and rigor of notified bodies, create uniform standards – more detailed rules on what is expected from notified bodies)
  • central assessment for new and emerging technologies – central function in the EU for joint assessment of new technologies to ensure common approach (newish too, no clarity as to what this will look like exactly)

Clinical evidence (some newish)

  • Clinical data for pre-market assessment (clarification of data required sufficient for market access, but balance between pre- and post market remains (clearer definition of the clinical evidence “tipping point” marking the moment that market access is possible))
  • Post marketing surveillance (increased role for serious post marketing surveillance in clinical evaluation loop for devices)
  • Rules on clinical investigations and coordination of safety-relsated aspects of the assessment of multinational clinical investigations (make easier to do multi-state trials – rules will be similar to pharma clinical trials directive, concept of sponsor: this is also newish)

Post-market safety (not that much new)

  • Key to EU system – trade-off for relative ease of market access but must be taken seriously by all stakeholders, including notified bodies and member states, and system must ensure consistent and timely reactions to safety issues
  • Enhanced coordination and vigilance cases and market surveillance activities (increased use of Eudamed and EU level trend analysis, EU level trend analysis is new)
  • Enhanced involvement of HCPs and patients in reporting of incidents, because there is currently a big weak point in the directives on this point.
  • No plans currently for GDP, Ms Minor answered to a question from the room.
  • All areas of product are affected by the lack of resources on member states level, said Ms Minor in response to question: safety has a price that member states must be willing to invest in – member states may review financing models and move to fee based financing (notified bodies to pay fee for designation, Eudamed registration fee, among others; should be fairness correction like at EMA currently)

Transparency (nothing new)

  • Central registration of medical devices and relevant economic operators in Eudamed
  • Public access to the Eudamed database (data on whether a device is approved and performance data summary information, like in the US), which will form the basis for EU UDI system

Access to external expertise (nothing new)

  • Panel of scientific and clinical experts will be set up to advise the European Commission on a permanent basis
  • A network of reference laboratories (for IVDs specifically) will be set up, like already happened for food safety and pesticides

Governance (newish)

  • Infrastructure and mechanism for harmonised interpretation and implementation (creation of a new agency will not work for Commisison under current circumstances; expand EMA to take on responsibilities is resisted by industry and Commission is not in favor of it either; Commission preferred solution is stakeholders groups put together in a body tasked with harmonised interpretation)
  • administrative, technical and scientific support (including IT) by EU body
  • cross-sectoral solution of borderline cases (perhaps the Dutch solution I wrote about after last year’s DIA Euromeeting in Geneva)

So, where are we now?

  • Proposal still slated for summer 2012 – proposal somewhat delay compared to April target, Commission did stress test on proposal with PIP cases fall-out and it seems the Commission considers that the outcome of the stress test required not that much adaptation of the proposal (which so far only has been presented in disjointed pieces to the stakeholders, so the entire proposal remains still unclear).
  • Two regulations, one for medical devices and one for IVDs – shorter lead time for entry into force (but, I predict, a more politicized legislative process as that process will be the only opportunity for member states to exercise influence on the resulting legislation)

What will the Commission do in mean time, and what has it asked the member states to do?

A regulation will take about three years to become effective after it enters the legislative process, so what will the Commission do in the mean time and what did it ask the member states to do? Ms Minor mentioned the following:

  • A letter was sent by Commissioner Dalli asking member states to implement a series of measures concerning supervision of notified bodies and enhanced market surveillance (letter not public, contents more or less identical to speech of Commissioner Dalli)
  • Precursor: centralization of vigilance work to expert group at Commission (Commission likely to contract out an analysis of EU level vigilance data to see if there are significant trends)
  • Traceability guidelines to be issued by Commission
  • Patient registries – will they help with traceability and give information about device associated risks?
  • Commission to investigate how healthcare practitioner incident reporting be can improved
  • High level meeting in May with Health Ministers to address the above points.

Recast

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27/03/2012

4 Comments

Axon seminar Cell-Based Therapies, Amsterdam, 18 April

I hope you won’t mind me doing a little bit of marketing for the non-devices activities of my firm. Axon Lawyers organises a seminar on cell-based therapies on 18 April in Amsterdam, which will be very interesting for companies thinking about or already underway with such products in the EU as it will be specifically focused on the difficult questions and practical problems that a company faces in bringing this type of product to the market. We have secured some veritable opinion leaders in the field and attendance is completely free, but please RSVP so we won’t have to disappoint people. If you feel this seminar would benefit anyone, whether in your company or not, please feel free to forward the invitation. If you would like to receive the seminar presentations and handouts, we will be happy to send them to you if you send us an email at the RSVP email address.

Advanced therapy medicinal products

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21/03/2012

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New EU guidance on medical devices vigilance reporting – more than meets the eye

The ongoing EU MEDDEV bonanza that started this January has produced yet another new document, in this case a new version of the MEDDEV 2.12/1 Medical devices vigilance system, now at revision 7. It is clear that the EU is upping its game on vigilance with the ongoing criticism on the CE system for medical devices, whether warranted or not, in mind. If you ask me, I think the system is good on paper but the execution can be much improved. We will have to see where the currently ongoing revision takes us. Snippets of the text are now circulating amongst stakeholders, but a complete proposal is yet to be seen and no one is sure what consequences the PIP scandal will have for vigilance requirements in text that will be proposed and how this proposal might be amended in the European Parliament. In all permutations it’s however safe to assume that the vigilance requirements will become a lot stricter, much more mandatory and very much more prescriptive.

So, what is new in this vigilance MEDDEV? In the words of the document itself:

“Revision 7 of MEDDEV 2.12-1 incorporates two new Report Forms (Annex 6-Manufacturer’s Periodic Summary Report and Annex 7- Manufacturer’s Trend Report Form) and updates two existing Report Forms (Annex 3 and Annex 4).”

These forms are convenient and follow GHTF state of the art. But that’s not all, there is a lot more to this document. Check out the compare I made of this version with the earlier one that shows a lot of interesting little updates and some major ones.

  1. The extended geographic scope to Turkey is important. Although you might argue that everyone should be aware of this already, I am sure that many will not be. It just shows how the 1963 customs union agreement between the EU and Turkey continues to have new consequences that also impact on medical devices regulation, like for example the right of Turkey to appoint notified bodies and whether Turkish manufacturers need authorised representatives for the EU that the Commission described in guidance for the first time in early 2010.
  2. Eudamed obligations for the authorities and the consequences have now been embedded in the guidance document.
  3. The MEDDEV refers to the newer GHTF SG2 document N54 ‘” Global Guidance for Adverse Event Reporting for Medical Devices” for further guidance on reporting obligations” rather than the older document GHTF/SG2/N36 Manufacturers Trend Reporting of Adverse Events from 2003.
  4. The FSCA part mentions that an FSCA can also include follow up of patients, users or others (see § 4.6), which should not be a surprise for a responsible manufacturer, and follow up of patients of course being the ethical thing to do in line with ISO 14155 principles.
  5. Small update on what does not constitute a reportable incident: “an intervention by the user or an immediate remote intervention by the manufacturer allowed the [device] to resume the analysis, resulting in correct results.” (see § 5.1.3.4)
  6. The examples of reportable incidents have been expanded upon (see § 10.1) with specific examples of reportable FSCAs, for example correction of software bugs.

The revised guidance will be applicable as of 15 June 2012, according to the MEDDEV.

PMS, Recast, Vigilance

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19/03/2012

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E-labelling regulation published, no changes / big disappointment

Just before last weekend the final e-labelling regulation was published in the Official Journal of the EU, see right here. As you will see when you run a compare (like I did) there is absolutely no change compared to the last version that was available among stakeholders. For that reason, I will not repeat all the things I wrote about it here and here.

Suffice to say that the criticism voiced earlier is now set in stone as far as I am concerned because the industry will have to live with this piece of legislation that I would label as a truly missed opportunity for the EU.

Just to summarise for those who do not feel like reading my earlier discussion of the regulation, it only applies to

(a) active implantable medical devices and their accessories covered by Directive 90/385/EEC intended to be used exclusively for the implantation or programming of a defined active implantable medical device;

(b) implantable medical devices and their accessories covered by Directive 93/42/EEC intended to be used exclusively for the implantation of a defined implantable medical device;

(c) fixed installed medical devices covered by Directive 93/42/EEC;

(d) medical devices and their accessories covered by Directives 90/385/EEC and 93/42/EEC fitted with a built-in system visually displaying the instructions for use; and

(e) stand-alone software covered by Directive 93/42/EEC.

It requires manufacturers to conduct a risk assessment about the use of e-labeling for the device concerned that must have a positive outcome and involves assessment of the circumstances under which it is used, which must be updated based on information gained in post marketing surveillance . Finally, there are a lot of labeling specifics, both for the e-IFU itself and for the device concerned – want detail? Read the discussion about those here.

So, in the end – be careful what you wish for for manufacturers with devices in scope, disappointment and missed opportunity for all others as the scope of devices (to me and to others) seems to have been established rather arbitrarily. I could live with the criterion that the devices concerned should be used by professional users, but why the limitation to implantables and their accessories, fixed equipment, capital equipment with screens and standalone software? This proposal could have been so much better, for example by allowing central storage of all paper manuals in a central repository in medical institutions under the responsibility of the institution itself  with e-IFUs available throughout the institution, which is what already happens in practice anyway. That would have been the way to go, as the manufacturer can presently not control how the hospital uses the IFUs in the first place – and now manufacturers must do a risk assessment on how the hospitals use them? Most of my clients inform me that the hospital tosses them in the waste immediately and asks for PDFs on a suitable storage medium or does not even go that far and just trusts they will be able to find it on the manufacturer’s website if needed. The proposal goes completely against all developments currently going on that only lead to healthcare professionals accessing more and more data electronically from handheld or bedside devices, so just to repeat myself: a truly missed opportunity for the EU.

Accessories, eLabelling, Labeling

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13/03/2012

1 Comment

Update on Eudamed and its implications for vigilance in the EU

This will be a very short post, because everything I could write down on the subject is in the interview I had with Ashley Yeo of Scrip Regulatory Affairs, that kindly consented to publication of the article on my website, so here it is. It puts current and future vigilance initiaties, including the Eudamed database, in the perspective of the ongoing fall-out of the PIP scandal and contains some speculative predictive statements about where things are going.

PMS, Vigilance

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21/02/2012

2 Comments

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