medicaldeviceslegal

When Gert Bos and I wrote BSI’s white paper on the impending EU medical devices regulation and the IVD regulation, the white paper was received very well but we also received requests to write something more detailed and practical.

Here it is

So we did just that. And here it is – the next BSI white paper on the MDR, written from the perspective of a medical devices manufacturer that is faced with the MDR on the horizon and has to figure out what to do.

Chapter by chapter

We’ve taken the MDR and annexes apart in their constituent chapters and have described for each chapter what it means for the manufacturer and what the manufacturer can do to prepare for compliance before, during and after the transitional period following the entry into force of the MDR. The “do’s” are set out in convenient tables per chapter and in the overview version of a consolidated table in the back of the white paper.

Of course things may still change because the text of the MDR is still not final yet and the different versions of proposals by Commission, Parliament and Council differ considerably on some points. Where that is the case we have used our best judgement on where we think that particular item will likely land in the final text.

Did we miss anything?

We have tried to be as practical as possible but of course it is not possible to cover every permutation in the white paper. Also, we’re just legal and regulatory nerds with our own perspective on things that might be different from yours (although our valued reviewers helped us a lot in that regard). If you feel that we have left out anything important we would love to hear from you so we can take it on board in an updated version so everybody can benefit.

In the mean time: where is the MDR?

The short answer is:”it’s complicated”, still. From what I hear these are some of the distinct forces that slow down the trilogue:

• Germany defending reprocessing of single use devices;
• France and a coalition around them as well as the Parliament want centralisation of market access controls in some kind of EU competence (EMA like agency, special notified bodies), while other member states do not want to delegate more power to Brussels;
• the European Parliament attaches great importance to lifestyle testing issues and genetic testing (IVDR issue) and wants an expanded definition of what consitutes a medical device;
• there is a strong Parliament political commitment to a mandatory product liability for medical devices manufacturers and authorised representatives
• Parliament has plans to radically change  CMR rules to something that goes beyond labeling (meaning a complete short term phase out, as they proposed)

Then the transitional period has become a policital issue because as result of intensive lobby the politicians are starting to realise that three years is a very short transition period if there is no grandfathering whatsoever. So now there is a lot of discussion about how to make this more workable, e.g. by allowing certificates to be issued under the old rules until the end of the transitional period with full 5 years validity (which is not possible in the initial Commission proposal).

The Dutch presidency is aiming for a ‘second reading agreement’ in by June 2016, resulting from 3-5 political trilogue meetings and more than 10 technical meetings. The Dutch are planning to have a dialogue that is as inclusive as possible and act as ‘honest broker’ for all member states. The Commission, in the mean time, seems to be getting increasingly impatient  and may even start to think about putting the option to revoke the proposals altogether on the table. When that happens the Commission could start again with a new proposal at the status quo of what it knows works for the Council and the Parliament or just propose incremental improvements to the existing directives instead.

Horse trading patterns are difficult to spot at this point because of the way the trilogue works and because all involved are keeping a very tight lid on things. If, at the end, one of the actors is not happy with the way their scored items add up, they can still refuse to accept the result unless they get this or that and it’s at that point where the real horse trading starts.

My expectation

My expectation is that there will be a lot of difficult meetings increasing the pressure towards the end, and there may be a surprise (like the Council general approach at the end of the Latvian presidency).

But there also may not be, and what happen then depends on (1) if the Commission is getting fed up enough with the way things are bogged down then and (2) on if the institutional actors are numb enough to come to quick agreement in the following Slowakian presidency. Who knows, the central European presidencies have caused the biggest breakthroughs so far.