BSI white paper on EU medical devices revision

13_img0_BSI Core LogoAre you still with me on where we are with the EU revision of medical devices and IVD legislation?

If you are, you have strong tolerances for fast moving complexity – congratulations! – because so far it has been a wild ride so far with drama, denial and divergence. And it looks like it will not be finished soon.

If you’re not, don’t blame yourself. It is not surprising that you may feel a bit in the dark about where exactly the whole process is, and what the bigger picture looks like. Well, fret no more.

BSI Healthcare decided that it would be a good idea to produce a nice concise white paper explaining the bigger picture, subtitled “An overview of the likely outcomes and the consequences for the market” so no dry descriptions of procedural steps or repeating of what everybody else is saying.

I was honored that BSI asked me to contribute and it was a pleasure to work on it with Gert Bos (Head of Regulatory and Clinical Affairs at BSI). We are very grateful for the work put in by the expert reviewers and members of BSI’s medical devices white paper advisory panel.

And here it is. I hope you will find it useful.

We have not only tried to be as practical as possible (and managed with the help of our reviewers), but have also discussed subjects like future-proofing of the new regulations, 3D printing of devices, impact on own brand labelling and how to manage your transitional processes (mind you: the EU does not allow grandfathering of devices so all your existing devices must be certified under the new rules sooner or later).

Are you in IVDs? Then you are up for a regulatory quantum leap, which is discussed in a fair amount of detail as well. The discussion is focused way too much on the medical devices regulation proposal, while the IVD market is awaiting some big regulatory changes as well.

It’s also one of a series of white papers in medical devices that BSI will produce in the course of this year, so there is more to come.

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The new Blue Guide is here

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After a royal time of suspense, the new Blue Guide has finally arrived. Was it worth the wait and what is new and noteworthy in medical devices? Let’s see. I will take you through this substantial document in a number of blogs, of which this is the first.

Some history

But first, for those who are not familiar with the Blue Guide, a little bit of history:

“The Guide to the implementation of directives based on the New Approach and the Global Approach (the “Blue Guide”) was published in 2000. Since then, it has become one of the main reference documents explaining how to implement the legislation based on the New Approach, now covered by the New Legislative Framework.

Much of the 2000 edition of the “Blue Guide” is still valid but it requires updating to cover new developments and to ensure the broadest possible common understanding on implementation of the New Legislative Framework (NLF) for the marketing of products. It is also necessary to take account of the changes introduced by the Lisbon Treaty (in force since 1st December 2009) with regard to the legal references and terminology applicable to EU-related documents, procedures, etc.”

To me the Blue Guide from 2000 has been immensely helpful for interpretation of crucial concepts in medical devices legislation, like ‘manufacturer’, ‘authorized representative’ and ‘placing on the market’, just to name some. And its fabulous flow charts outlining conformity assessment procedures made things a lot more transparent.

What is new?

The Blue Guide itself says:

“This new version of the Guide will therefore build on the past edition, but include new chapters, for example on the obligations of economic operators or accreditation, or completely revised chapters such as those on standardisation or market surveillance. The Guide has also been given a new title reflecting the fact that the New Legislative Framework is likely to be used, at least in part, by all types of Union harmonisation legislation and not only by the so-called “New Approach” directives.”

But there is more. I was very happy to find a relatively comprehensive guidance on international aspects in the form of pretty detailed discussions of international (with that I mean: outside of the EU) aspects of CE marking, including mutual recognition and geographic scope in chapters 2.8 and 9. This was already addressed in the old Blue Guide, but this update is current now and more detailed.

The chapter 7 on market surveillance contains a discussion of the new (not so new anymore) provisions on customs competences with regard to CE marked goods. Always convenient to know if you consider enlisting customs to help achieve your purposes which we love to do as litigious people that lawyers are.

There is a new 1 page chapter (chapter 8) on Free Movement of Products Within the EU, which discusses the free movement clause and restrictions / limits that the member states still impose. It is unfortunate (to say the very very least) that the Commission has not been able to include a discussion on the consequences of the Lycocentre-case. This EU court  judgment, as I have blogged, puts a major stick in the wheel of free movement of medical devices in the EU internal market. A discussion of its consequences for free movement would have been more than welcome in this chapter. Also, this big flaw in the internal market for medical devices something that could still be fixed in the proposals for the IVD and medical device regulation, which include limited powers for the Commission to make central qualification decisions. However, this limited step forward will not protect companies against the often very poorly supported reasoning that member states use to qualify products differently. The scientific quality of qualification decisions by member states can be disappointingly low and sometimes is just downright and objectively wrong. The Lycocentre case makes it much easier for member states to get away with their version of science. Going to court over what the correct scientific conclusion must be is, as you can imagine, not a nice prospect because judges are not scientists either and are inclined to give authorities the benefit of the doubt if their are not manifestly besides the point.

What is interesting –  authorised reps

As I have blogged before, the legal status of authorised representatives under the medical devices regime has my special attention at the moment. Consequently, I was puzzled to see the following statement casually scuffled away in footnote 57 on page 19:

“Please note that in the area of medical devices, the role of the authorised representative is reinforced and he is the primary interlocutor of market surveillance authorities for products for third countries.”

What is meant by “reinforced” here? I am pretty sure I have not missed an amendment of the medical devices directive and subsequent amendment of national law since the last amendment in 2007 in directive 2007/47. I am also pretty sure this is not a reference to the definition of the concept in Regulation 765/2008, which, admittedly, does define the concept differently but does so in a general way, and not specifically for medical devices. Also, regulation 765/2008 actually seems to do the reverse of reinforcing by using the words “act on his behalf in relation to specified tasks” rather than the wording of  “acts and may be addressed [...] instead of the manufacturer” used in directive 93/42 (which the Dutch authorities have taken to mean now that you can enforce against and fine the authorized representative for whatever regulatory mistake the manufacturer makes).

765/2008 Directive 93/42
‘authorised representative’ shall mean any natural or legal person established within the Community who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks with regard to the latter’s obligations under the relevant Community legislation; ‘authorised representative’ means any natural or legal person  established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter’s obligations under this Directive;


Perhaps the reference is to the MEDDEV on authorised representative? But that MEDDEV starts with a disclaimer that it is not legally binding and that it reflects “positions taken by representatives of interested parties in the MEDICAL DEVICEs sector”. It does provide for some additional guidance in the section B. Member States’ Expectations in which member states’ expectations in some scenarios of noncompliance by the manufacturer are discussed:

“- In the event of a disagreement, where the authorised representative considers that the manufacturer is not complying with the requirements of the Directives, it has a duty to communicate this to the manufacturer. If the disagreement continues, the matter should be submitted to the authorised representative’s Competent Authority for decision. The authorised representative may opt to rescind the contract.

- In the event of a clear non-compliance by the manufacturer that could engage the responsibility of the authorised representative and which the manufacturer refuses to correct, the authorised representative has the right to rescind his contract with the manufacturer. The authorised representative has even the obligation to rescind the contract if the non-fulfilment of the manufacturer’s obligations causes him to infringe national law. It should then notify his Competent Authority and the manufacturer’s Notified Body of this.”

It is unclear to me however how this ‘reinforces’  the authorised representative role, because it just says that member states expect authorised representatives to structure their contracts to include specific agreements. It also suggests that authorised representatives have certain rights to terminate their contract, which, as I have blogged, utterly lacks legal basis because a MEDDEV cannot intervene in national contract law and therefore cannot ‘reinforce’ their rights.

To conclude, I am very interested to understand what the Commission means with what looks to me like a slip of the keyboard. Anyone of you readers that can help me understand this?

More to come

This was the first of my series of blogs on the new Blue Guide. Watch this space for more.

2 April 1st reading vote: what’s next for the MDR and IVDR?

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We had the first reading vote by the European Parliament on 2 April. Let’s put it in perspective.

The previous last important iterations in the legislative process are the EP’s plenary vote on 22 October 2013 and the Council’s discussion of the MDR proposal with respect to reprocessing and market access mechanism.


The Parliament’s plenary vote has in the mean time been voted on in a formal first reading by the Parliament on 2 April 2014  as to fix the proposal. The reason for the Parliament to do this now is essentially to fix rapporteur Roth-Behrendt’s fact-free legacy to make it more difficult for a new Parliament to easily change it after the elections (“The European Parliament voted on its first reading of the draft legislation, in order to consolidate the work done so far and hand it over to the next Parliament. This ensures that the MEPs newly elected in May can build on work done during the current term.”, says its press release) and to  force the Commission and the Council to move forward on the dossier, which it hoped they would have started to do way before.


This means that the Commission is now also on the spot. The next procedural step will be the formal response of the Commission in 4-5 weeks. and has to decide whether to go along with the Parliament’s text or to come up with its own amendments. So far the Commission has been keeping its cards very close to its chest as to not upset the political actors it has to deal with in the procedure.

Happy Parliament?

Do we have a happy Parliament now? They did confirm the 22 October 2013 position with overwhelming votes, but also with a telling 63 abstentions. Of course the ENVI committee claimed victory in a press release stating that there would be “better controls”. Much more interesting was the press conference that rapporteur Roth-Behrendt held afterwards, in which she basically blamed everybody but herself for the way this dossier is spinning out of control politically, conveniently ignoring the political handgranade she exploded with the ENVI committee position and unfounded crass accusations on the part of stakeholders, which basically destroyed the possibilities for normal dialogue with stakeholders. You can watch the video for entertainment purposes and amaze yourself about how many unfounded fact-free statements a departing politician can spout in a short while. Or you can save yourself the aggravation and satisfy yourself with the twitter summary in tweets of the ever observant Robert van Boxtel / @robertmdproject pasted in this blog on the left. When rapporteur Roth-Beherendt is gone, hopefully cooler and more evidence based minds will prevail in the Parliament and we might actually even get somewhere with this dossier.

Happy member states? Where do we go from here?

Get somewhere…. that would be nice. But we also need the Council. And the Council is hopelessly divided tat the moment. Persons involved in the Council negotiations have informed me that also on many other important points the member states are as divided as transpired in the last Council meeting that publicly discussed the proposals. There are shifting coalitions in different subjects. Even after the 1st reading in Parliament the Council is not under a deadline at this stage in the procedure, and as yet has not started to negotiate with the EP with a view to reaching a compromise text. The current expectation is that the member states will not reach a compromise with the EP before the European elections in May 2014 and probably not before the end of 2014. Even though the Greek presidency promised to get somewhere with this, it is unlikely that they will. The trialogue between en Commission, Parliament and Council will therefore likely not begin before early 2015. The elections may well reshuffle the political landscape, which leaves a lot of insecurities about the legislative projects of MDR and IVDR post-elections, regardless of the Parliament’s first reading.

The MHRA’s new guidance on standalone software as medical device and DIA Euromeeting update


A nice repack, with some additional little gems. That’s how I would describe the recently released MHRA guidance on standalone software as a medical device.

The guidance of course has to color between the lines of the existing MEDDEV on standalone software (which itself is under revision currently but seems to have been bogged down considerably in the responsible MDEG because of a competence struggle between the software MDEG and the borderline MDEG), so the added value is limited for those that already are familiar with that MEDDEV. On the other hand, if you compare it to the Swedish guidance 2.0, you can clearly see that the MHRA is much closer to the scope of the MEDDEV than the Swedish MPA, which in itself is also added value.


The guidance contains a convenient list of words commonly associated with medical device functionality, or, in the words of the MHRA are “likely to contribute to a determination by the MHRA that the app they were associated with is a medical device”:
  • amplify,
  • analysis,
  • interpret,
  • alarms,
  • calculates,
  • controls,
  • converts,
  • detects,
  • diagnose,
  • measures,
  • monitors

This list is slightly different from the list of operations of ‘altering’ of medical data given on p. 10 of the MEDDEV because it goes quite a lot outside the scope of that concept of altering and, therefore, is of interpretative value. Officially this is only the MHRA’s view, and not all other EU competent authorities may share this interpretation, even if that would be a good idea.

Paper IFU

The guidance also confirms the official need of a paper IFU for an app for lay persons, which, as I have blogged before, is a very unhelpful rule that really needs to be revisited if we want to take the eHealth, mHealth and apps sector to the contemporary reality of things. However, I have found the delegation from DG Connect very receptive to the need for change here at the DIA Euromeeting in Vienna today when I presented in a session on mHealth, eHealth and apps with them (see below for my presentation). Hopefully their colleagues at DG SANCO will share their concerns.


More guidance on classification would have been nice, because I experience more and more that rule 10 does not work for standalone software that is somewhere the middle as an active device for diagnosis between medical devices that measure vital physiological parameters and a clinician, particularly because the classification MEDDEV only mentions the devices that do the actual measurement on the patient as “intended to allow direct diagnosis or monitoring of vital physiological processes”. When I tweeted the MHRA about this, I was referred to the general classification guidance, which is exactly what does not solve the problem.

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Yet, the connected devices guidance is useful. It confirms the distinction between CE marking of a system as a whole and the logic of EU medical devices law that says that each device need to be classified in its own right based on its own intended purpose.

More guidance on the application of classification rule 2.3 (“Software, which drives a device or influences the use of a device automatically falls into the classification of that device”) would have been nice with regard to standalone software in the middle, as mentioned above.

Green Paper and expanding definitions

An important contribution to the discussion about borderlines between medical devices and general health/wellness software will come from the Commission’s Green Paper that  will be published shortly – likely end of April – with a consultation running until June this year. The green paper will be accompanied by a Staff Working Document on legal issues in this respect, I expect much along the lines of the SWD on telemedicine. This was confirmed by the European Commission at the DIA Euromeeting today. Paul Timmers of the Commission’s DG CONNECT gave a great comprehensive overview of the eHealth Action Plan, where that is now and where it is heading. It was very nice to see how open the Commission’s DG CONNECT people are to hearing about regulatory Catch-22s that limit the possiblities of eHealth, like the eLabeling regulation.

Moving and shaking

That’s what the standalone software field under EU medical devices regulation currently is. Watch this space for discussion of the Green Paper and the SWD when they are published.

Axon Seminar Clinical Trials with Medicinal Products and Medical Devices on 9 April in Amsterdam


The results are in: EU Study on Corruption in Healthcare Sector

Schermafbeelding 2014-03-09 om 10.18.31This spring holiday I took the recently published Study on Corruption in the Healthcare Sector with me as holiday reading and that proved a good choice. The 332 pages long study was commissioned by the European Commission (EC) Directorate-General Home Affairs and involved cooperation between Ecorys, the European Healthcare Fraud & Corruption Network (EHFCN) and individual country correspondents in 28 European Union Member States.

It serves as input to the first EU Anti-Corruption Report, which is part of the overall anti-corruption strategy initiated by the European Commission in 2011.


The study’s objectives are to

  • enable a better understanding of the extent, nature and impact of corrupt practices in the healthcare sector across the EU; and
  • assess the capacity of the Member States to prevent and control corruption within the healthcare system and the effectiveness of these measures in practice.

The focus lies on three areas of healthcare: (i) medical service delivery (various forms of informal payments); (ii) procurement and certification of medical devices; and (iii) procurement and authorisation of medicinal products.

Useful for compliance counsel

As I have been able to determine for myself, this focus makes the study report very useful tool for compliance counsel and/or staff in a larger medical devices (or any healthcare) company that does business in Europe and that has to match business compliance obligations in multiple areas and under different statutes with international dimensions, like the US FCPA and UK Anti-Bribery Act.

The study uses the term ‘corruption’ quite loosely. In the study this term covers a plethora of practices that a company may be faced with (and possibly engage in) when doing business in the healthcare sector in the EU, like misuse of influence, bribery and unethical marketing practices. It gives a nice typology of modalities corruption in healthcare, lists a large number (86) of case studies and in the process does a great job of describing compliance risks in the respective member states (although the writers of the report clearly received more input from some member states than from others).

What industry is not to allowed to give, doctors shouldn’t be allowed to ask

The study does a good job of describing the dilemma of lack of funds for training and (continued) education for physicians and the widely held expectation that industry will pony up the required funds one way or the other without being allowed to expect anything special treatment or consideration in return because that would be unethical.

The study clearly describes the – in my view – often neglected / overlooked role of the medical profession and healthcare institution management in initiation and perpetuation of unethical practices. While the study focuses on prosecution of individual doctors, it does not mention very positive developments like in the Netherlands (the study often refers to the Netherlands) where the associations of hospitals and doctors have also adhered to the self regulatory GMH Code. This way the loop has been closed – albeit with some firm coercion from the Ministry of Health to make the medical profession take their responsibility in this respect. This kind of closing the loop is – in my view – the only way to reduce unethical behavior in the healthcare market. You may say that I suffer from professional cynicism, but as long as the demand side still can expect behavior that is deemed unethical when exhibited on the supply side, unethical supply and unethical demand will always find a way to connect and it is in practice pretty difficult to determine what side initiated the unethical practice.

Certification fraud

The report also has a section discussing certification fraud / corruption with respect to medical devices, which is interesting in the light of recent accusations addressed to the notified bodies following the PIP breast implants and metal-on-metal hip implant cases that they are not well equipped to be gatekeeper for medical devices market access that played an important part in the medical devices directives revision. I must say I was a bit disappointed by the discussion in the report, which was somewhat thin and the conclusion seems to suggest issues the report does not support. The study report spends some time defining possible risks, like the alleged revolving door between industry and notified bodies / regulators, and describes developments in the new notified bodies code of conduct by Team NB. However, it does not discuss to a single concrete case and suffices to state that:

“Within the areas of pharmaceuticals and medicals devices very few cases have reported concerning the specific issues of authorization and certification. This may be the result of the rather technical nature of these processes that are only known in detail by a small number of people in each country. This may have influenced the identification of issues and nature of interview respondents in several countries.”

It may have also been that just almost no cases exist in this respect, which is the study seems to want to deliberately overlook as another plausible conclusion.


Personally I was very happy with the good work on compliance issues in procurement and the detailed topology of all the ways that procurement processes can be unduly influenced both from the outside and from the inside. The study gives a balanced overview of things by also discussing the doctors’ and healthcare institutions’ role in procurement compliance issues. If your company sells via tenders in the EU, this is a section of the study you should definitely read.

Local differences

The study describes the different ways that member states are dealing with the compliance issues in healthcare, and proves what everyone in EU compliance matters already knows: there is no one size fits all solution that works in the same way in every member state. The issues are also not of the same type and prevalence in each member state.

The study goes into a lot of detail when describing the different systems that member states use: self-regulatory rules as well as criminal, administrative and civil law. It shows how some approaches worked and how some failed. Interestingly it also tries to show how the failed approaches failed because they failed to provide the right (dis)incentives, with unintended consequences as result.


As a conclusion the study recommends that

“to address drivers of corruption that prevail in all EU MSs, EU-wide policies are needed. At the EU level it is recommended to a) set clear and effectively enforced general anti-corruption rules (e.g. UK Bribery Act and US Foreign Corrupt Practices Act), b) introduce independent and effective judicial follow up on corruption cases, and c) implement sound and transparent general procurement systems. General public procurement policies should also apply for the healthcare sector.

Another aspect that can be addressed at EU level concerns self-regulation, for example through a Code of Conduct or Code of Ethics. Industry organisations at the EU level, such as EUCOMED and EFPIA, have these already in place for their members. Self-regulation should also be organised at a national level. The good practices in the Netherlands and the United Kingdom illustrate that conditioned self-regulation can be an effective way of regulation a sector. It is recommended to find the right balance between formal regulation (legislation) and self-regulation and clearly define how the two function in parallel and complement each other.”

That is easier said than done however. The European Commission does not have any formal tools to make groups of companies work together and in practice the different groups in medicinal products and medical devices do not always cooperate smoothly. Cooperation in self-regulation will need to be a bottom-up approach, like the process of convergence that EDMA and Eucomed have started under the MedTech Europe name. But we have the Dutch on the case now trying to see if they can get an EU level policy started by gathering support from the other member states for addressing HCP-industry relations in the draft medical devices regulation. So far they have not gotten much traction, which shows that the member states are divided on this.

At national level the study recommends effective sanctions, transparency and active reporting by media, patient groups and individuals. Not the most surprising of conclusions perhaps, but that is often the case with empirically answered questions that do not falsify the initial intuitive answer to the research hypothesis.

Useful stuff in the annexes

The annexes contain useful very useful information for companies, such as

  • case studies;
  • overview of perceptions of corruption in the member states;
  • country reports per member state, with very convenient descriptions of the healthcare systems (including reimbursement systems) and compliance phenomena observed; and
  • a corruption risk checklist.

In other words, a wealth of useful information that you would otherwise pay a consultant a lot of money for. Use it at your advantage.

Want to know more?

Aline Lautenberg, the General Counsel – Director Legal & Compliance of Eucomed puts the study in the context of other developments in her recent blog post here. The report and other developments will be discussed at the Global MedTech Compliance Conference in Barcelona on 20-22 May. See you there!

3D printing of custom medical devices under future EU law

European ParliamentLately I have thought a lot about future-proofing of the new EU regulation proposals for medical devices and IVDs, specifically with respect to the development of 3D printing of individualized (custom) medical devices – which is well on its way with more and more companies joining the fray. With companies like Siemens and GE investing big in manufacturing processes for complex parts in e.g. aircraft engines, it’s just a matter of time before Moore’s law seriously takes off in 3D printing.

Think devices like prosthetic limbscustom exoskeletons, but also a wide variety of implants, like a an electronic glove for the heart that functions as pacemaker. Is the proposed medical devices regulation sufficiently equipped to regulate custom devices that are manufactured by 3D printing across the full risk profile spectrum?

My conclusion is: not even close, which is why we need to rethink the regime for custom made devices now that the regulations are still in the process of adoption. Here are some thoughts of mine in that respect.

Proposed low regulatory burden will not work

The big added value of 3D printed medical devices is the unlimited potential for customization of the devices, so they can be produced precisely to fit the individual patient’s needs and measurements. Custom made medical devices however currently enjoy a very light touch of regulation under the current MDD, and are proposed to continue to do so under the new regulation. The Explanatory Memorandum to the MDR states that

“Manufacturers of medical devices for an individual patient, so called ‘custom-made devices’, must ensure that their devices are safe and perform as intended, but their regulatory burden remains low.”

That kind of approach is of course perfectly OK for low risk medical devices traditionally produced by custom medical device manufacturers like orthopedic shoes, but is a lot less appropriate for high risk stuff like 3D printed orthopedic implants.

Annex I Essential Requirements and prescribers

Custom-made devices will still need to meet all Annex I requirements under the new MDR like they must under the MDD, but the only safeguards are the manufacturer’s diligence, the prescription that defines the custom made device and the ex-post controls exercised by competent authorities. This will not change under the new rules as they are currently proposed. Is that sufficient control? I am not so sure, even after the implementation of the Joint Immediate Action Plan and a possible action plan version 2.0 that I have heard rumors about.

What will change is the group of people allowed to prescribe a custom-made device. If the Parliament has its way, this will be extended to all “professional users” that are “appropriately qualified” (consisting of “a doctor of medicine, a dental practitioner or any other professional user”), which potentially is a frightfully big group of people with potentially very different levels of professional qualification and expertise. It’s also not clear what the member states are still allowed to do here since the proposal is a regulation, intended to give the member states only the freedom of implementation defined in the statute. This means that member states will each take their own view of what an appropriately qualified professional user is and this will likely become another situation of straight up CE (Confusion Everywhere). I think this really needs a more coherent approach.

Industrial manufacturing process / customization vs custom-made

We already know from existing guidance that custom-made devices cannot be mass-produced. This is clarified in the new regulation proposal as follows in one of the Parliament amendments to the MDR to article 2(3) MDR, which contains the definition of custom-made device:

“However, mass-produced devices which need to be adapted to meet the specific requirements of a doctor of medicine, a dental practitioner or any other professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of doctors of medicine, dental practitioners or any other authorised person shall not be considered to be custom-made devices;”

Indeed, in the EU regulatory logic such devices are customizable ‘standard’ medical devices. The question is whether this excludes individualised 3D printed devices or not. That will really depend on whether 3D printing is considered an “industrial manufacturing processes in accordance with [...] written prescriptions”. There are good arguments to say that it is. The available EU guidance on custom-made products says that mass-production according to individual specifications can still constitute a non-custom made medical device. In the field of other regulated life sciences products such as ATMPs authorities have been very quick to find without almost no exception that the cells or tissues have been produced with an industrial manufacturing process, purely because the perceived risk profile invariably prompts them into a precautionary regulatory approach and shelter under the heaviest regulatory regime so they can never be wrong – at least, that is my personal experience with authorities in the field. You could also argue that 3D printing is customisation of a standard virtual device defined in a software model rather than custom production according to a production process that is not already fully determined in advance, which would be the case for a true traditional custom-made device.

At present, we don’t know yet where this will land, but it would be a good idea for the Commission to provide guidance on how it sees this. To me, an industrial manufacturing process is characterised by a standardised production method, which intends to ensure that each device is produced in the exact same way, using the same materials and the same manufacturing template, taking into account customization features that are implemented in the production process. This seems to fit manufacturing of individualised devices by means of 3D printing pretty well – and fits 3D printing of non-individualised devices without any doubt. Basically, 3D printing of custom devices is mass-production of devices that are customized in the production process, rather than producing ‘custom conceived and built devices one at a time’. The current custom-made devices regime assumes that the prescription specifics and the expertise of the custom device manufacturer are sufficient safeguard for the safety and performance of the device. This may be true for many of the traditional custom made devices, but will arguably not be sufficient for higher risk devices produced with a production process that the prescription cannot really change anything about, except provide for customization specifics.

Production quality requirements

A way to deal with the regulatory insufficiency is to require that manufacturers of higher risk 3D custom printed devices (e.g. implantable and/or invasive custom-made devices) shall be subject to a conformity assessment based on product conformity verification as specified in Section 7 of Part A of Annex X (see our consolidated text). This would provide for initial and regular follow-up notified body control of the production process, and an ex ante and continuing audit of whether the production process is capable of producing devices that meet the Annex I requirements as required. This solution has my own personal preference, because it does exactly what is needed in solving the production quality dilemma and can be inserted in the current text of the proposal with such minimal invasiveness that it should not even be controversial.

Input material medical device?

Yet another (or complimentary) way to control quality of 3D custom printed devices would be to require CE marking of the input material. This approach would require taking the view that the printing material is equal to, for example, CE marked filling materials that are used for creating a dental filling. That would fit current policy in the EU Guidance Note For Manufacturers Of Custom Made Medical Devices , which sets out specifically in this regard:

“Intermediate products specifically intended for manufacture of custom-made devices may also be considered as medical devices. This applies essentially to dental alloys, dental ceramics, modular components for prosthesis, if the intended purpose of such products is specifically related to medical devices.”

Since it is the intended purpose of the input material  that counts, manufacturers could be required to use CE marked input material. This would apply even if the input material is completely generic material, just like completely generic industrial gasses like oxygen must be licensed as medicinal products in a number of member states if they are to be used for medical purposes.

Regulate lower risk like home brew IVDs?

If 3D printing of all types of devices remains within the custom-made devices regime, I think the EU should consider some revisions to the custom-made devices regime. Characteristic for 3D printing is that it concentrates manufacturing in one place, and limits reliance on suppliers (except for the raw materials input for the printer). On the other hand, because anybody that can obtain the software models for devices can print them anywhere you can install a 3D printer (like in my own garage) quality systems become very very important. More so even if you would come to the conclusion that individualised 3D printed devices do not consitute devices fully subject to medical devices regulation. Yet, quality system requirements are precisely what is lacking in the new rules with respect to custom-made devices. As a result, 3D printing regulation in the medical devices field in the EU is not really scalable, unless you would bring 3D printing out of the scope of the custom made devices scope alltogether by taking the policy decision that 3D printing using software defined models consitutes manufacturing using an industrial process. Especially for higher risk 3D printed devices this seems a way to go, because it would involve certification of the quality system and production process by a notified body, ensuring a degree of ex ante controls on production and quality system.

A way to solve this for lower risk custom devices would be to include a regime analogous to the home brew IVDs regime set out in article 4 (5) of the IVD regulation proposal. This regime focuses on quality system requirements for the production of home brew IVD devices and makes sure that lab developed tests have at least been developed in an accredited laboratory, with the other requirements (e.g. ex-post notification to member state) being remarkably similar. This approach would help ensure that at least the production environment is controlled, which would be important for higher risk devices.

Several ways to Rome

As I have shown, there are several ways to Rome in this case, and it’s important that we take one. Proverbially speaking, your life is not complete if you’ve never visited Rome. I have pointed to a lot of instances of not very well-considered over-regulatution in the medical devices regulation proposal on this blog, but regulation of custom 3D printed devices is one area that is definitely stuck in the past given the developments in this field. If this technology delivers on its promises – and all the signs point to that it will – it will very soon be an important regulatory item the medical devices regulation cannot afford to not have seriously considered, especially because adaptation of regulation to new technologies (like nanotech) is one of the important drivers for the new regulation proposal.


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