medicaldeviceslegal

If you are still free this Wednesday afternoon and somehow involved on the medical devices industry in the EU, our seminar that afternoon in Amsterdam is for you as it discusses where we are with the implementation of the MDR and IVDR. We still have a few seats available, so this will be time well spent. Regardless of many requests we are not streaming or recording the seminar – we prefer the face to face contact. The presentations will be available on my firm’s website though.

Your time will be especially well spent because of the excellent speaker line-up:

• Gert Bos from Qserve on how to work with your notified body;
• Anja Wiersma from Mi-CE on what clinical, scientific and analytical evidence you will need for medical devices and IVDs and how to generate it timely;
• Erik Raadsheer from Align Technologies on how a medical devices company implements the MDR in a practical way; and
• myself about where we are with the regulations, implementation, Brexit etc.

The focus of the seminar is not on what the MDR and IVDR require in general (you should be well aware of that by now) but rather on where a company in medical devices and IVDs should be by now with its implementation work. The seminar will integrate the latest state of affairs with dependencies as e.g. Brexit as per the date of today.

Where should you be?

Not sitting on your hands, as I’ve been saying for a long time. I was moderating the EU MDR panel at Advamed’s MedTech Conference in Philadelphia on 24 September with so far the most mixed and complete panel so far with two competent authorities, a ministry of health, a notified body, an international devices company, a consulting company and MedTech Europe. It was a very good session with a lot of good information from the authorities.

It took place on a date nearly six years after the first draft of the MDR and IVDR were published and on the date that the MDCG had a meeting in Brussels to discuss progress of rolling out of these regulations. One of the pressing points is where the roll-out is and whether the regulatory system will be able to deliver on the daunting task of having to transition all medical devices and IVDs currently on the EU market to the new system in a shrinking amount of time with many parts of the regulatory system still unclear or up in the air. The big known unknown is if the notified body capacity that will at some point will become available to market gradually will be able to guarantee a transition that nobody anymore expects to be smooth – everyone will be happy if it is not too messy.

The shrinking time left until the Date of Application for the MDR (26 May 2020) has caused widespread hope and wishful thinking that the dates of application will be moved or that there will be other changes to manage the bottleneck expected towards the date of application. While industry is advocating a change of the implementation deadlines with the Commission and the member states because of the limited notified body capacity and the limited roll-out of implementation items and has put this on the agenda at the 24 September MDCG meeting, be very very warned that this is by no means certain to happen.

The panel gave a unitary message: no matter the degree of uncertainty about notified bodies and dates of application, your very worst option as manufacturer at the moment is to do nothing. If you are only starting the transition work now, you may be too late already, unless you have very few products in your company.

The panel also showed how the complexity of the EU CE system works against it at this moment:

• The competent authorities drafted the CAMD Roadmap but the implementation is left to the new committees under the MDCG that are replacing the current medical devices expert groups (MDEGs) and the authorities cannot make these committees deliver the documents and guidance in time. This is problematic because for example the work on the clinical guidance in the relevant group seems to have broken down for the moment.
• The ministries of health have delivered with the MDR and IVDR texts and for them there is not much to do, except focus on national implementation of the policy discretion that the regulations allow. We will take a first look at the Dutch implementation act at the seminar. Their message: work with what is there and you’ll be able to do most of the work. Notified bodies have to apply, and the applications must be good enough. They have provided and staffed an approval system for the notified bodies, but now the notified bodies are finding it more difficult than expected to meet the requirements for being a notified body under the new regulations, which especially affects the smaller notified bodies with a large scope. The first applicant notified body has in the mean time dropped out, having decided to put its money on consulting rather than being a notified body.
• Companies are getting exasperated because they require certainty for the rather considerable investments that they must make in the new system, while the system is still unfinished in several crucial aspects (like Eudamed and the essential implementing acts). They will happily so it generally because they are convinced that the new rules are in fact an improvement. However, it cannot be expected from industry that they fully commit to a system that is still being invented when it should have been ready, as this jeopardizes any meaningful use of the transitional periods.
• Notified bodies are in the middle: on the one hand they have to keep their business running and on the other hand reinventing themselves for Brexit and the MDR/IVDR application process take up a lot of their resources. I have heard that the audits for MDR/IVDR application are not a walk in the park at all and I think that especially for small notified bodies a large scope of designation will be very hard to pull off. While this is true for the bigger notified bodies that have an MDR/IVDR application in the water, the smaller notified bodies seem to have gone completely dark on what they are doing and what they are planning. The numbers of notified bodies applications for MDR/IVDR show that most of the notified bodies have not applied for MDR/IVDR designation. If you have a small notified body now with a full scope, better have a plan B and check if they have applied for MDR/IVDR, for what scope and if they expect to be able to support the scope you need. Don’t accept vague answers because they limit your options as manufacturer. It is unfortunate how only some notified bodies are trying to be transparent on where they are in the application process and what the consequences are for (AI)MDD recertification and MDR certificates. I appreciate that also for notified bodies there are a lot of uncertainties, but they can be clear on where they are in the process.

This shows that the highly decentralized EU system – which served the medical devices industry very well for a long time – now works against the objective of a quick and smooth transfer to the new system. Still, doing nothing is and remains your worst option – so, as the old Chinese proverb goes: are you going to curse the darkness or light a candle? If you light a candle, at least you might be able to shed light on some things and see them for what they are, which is always a good idea.

This is the time where everything you do as manufacturer is based on counting back from the Date of Application for your regulation (26 May 2020 or 2022), so you know how much time you still have to arrive where you need to be. Make no mistake, time is of the essence now. For example, if you are going for a renewal of your (AI)MDD certificate to extend past 2020, you should know when to hand in your application. That could be sooner than you think – according to a client communication of 2 July 2018 BSI requires it in the door by end Q1 2019 or they cannot guarantee that it will be processed timely. This means you may have to commit to an (AI)MDD certificate renewal before you are certain that your notified body is notified under the MDR. Have you got it clear what your notified body’s deadlines are and how this impacts what you are doing?

Also, if you have a UK notified body and a hard /no deal Brexit happens, do you know what this means for your CE certificates? The logical and legal consequence is that they will be invalid as of 30 March 2019 because the UK will be a ‘third country’ where no EU law applies as of that date (a transitional period only happens in case a deal is reached or if the EU is willing to unilaterally recognise certificates for (part of) their duration although the notified bodies that issued them have lost their notification) – do you have a backup plan for that?

Register for the seminar

If you’d like to join our seminar, please register here. As always, attendance is free and drinks afterwards in our newly expanded office space are on us!