Stop the Presses and add these earth shattering Regulations to your reading list for the next week or two:

• Medical Device Regulation (EU) 2017/745 and
• In Vitro Diagnostic Regulation (EU) 2017/746

Bassil Akra of TÜV SÜD some of the costs of this transition in his post on LinkedIn. It ain’t going to be cheap!

Back to our regularly scheduled post:

This Friday 5 May 2017 should be marked in your calendar or journal as a momentous date when the EU Official Journal will publish the Medical Device and In-Vitro Diagnostic Regulations and the transition periods for both start (3 years for the MDR & 5 years for the IVDR)!!  This is the start of a turning point for many medical device and IVD manufacturers as the clock starts ticking away til the end of the transition periods of these new Regulations.  If you haven’t started your transition planning strategies for your products & product families the pressure should be mounting quickly as there is so much to deal with for this transition time. Check out these resources for learning more about the MDR & IVDR. See below for some more details about the challenges you need to consider and START PLANNING for NOW (don’t wait)!

There is no grandfathering once the transition period ends for the applicable Regulation.  So, in 3 years and a day or so if you don’t meet the MDR or 5 years & a day or so if you don’t meet the IVDR you won’t be able to CE Mark your device and sell or distribute your medical or IVD device in the EU (& hopefully the UK which is in the middle of Brexit implications as UK will not be part of the EU by end of transition period).

We have talked about some of the challenges in the implementation of the MDR but here are more details to consider for your strategic planning:

• New definitions to deal with including nanomaterial, Unique Device Identifier, interoperability, economic operator, among other new & modified definitions.
• Person Responsible for Regulatory Compliance: Identify personnel that is  responsible for regulatory compliance with the Regulation and have a minimum work experience in the applicable device field and a minimum of academic qualifications.
• Enormous Single EU Database (not ready yet): Impacts all Economic Operators (which includes manufacturers) – Will register all devices, manufacturers, Economic Operators, CE Certificates, new clinical investigations, & incident reporting.  Will manage all Unique Device Identifications and Single Registration Numbers (SRN).
• Regulations are much more explicit now for the Quality Management System (QMS) & Risk Management System (RMS) requirements.  Beyond just what is in EN 13485 (ISO 1385:2016) & EN 14971
• Economic Operators (new to MDR): Impacts the activities of EU Representatives, Importers, Distributors & Manufacturers – Different Responsibilities depending on type of Economic Operators.
• Traceability of Devices Between Economic Operators: Between all Economic Operators (wow that in itself can be huge!) and all the way down to the healthcare institutions & in some cases down to the patients devices used on.
• Annex I now called Safety & Performance Requirements (not Essential Requirements): Much more prescriptive, addition of UDI & SRN to labelling requirements, all manufacturers will need to update all their Annex I checklists, new Clinical Evaluation & Clinical Performance Evaluations requirements
• Clinical Data: Much more prescriptive especially for higher risk class devices (class III & implantable devices) – Clinical Investigations needed in many cases now & restrictions of the type of clinical data allowed for class III devices (much more restrictive using equivalency data), post market clinical follow-up requirements for high risk class devices (i.e. annual summary reports for Class III & implantable devices).
• Notified Bodies: Much more prescriptive in competency requirements, conflict of interest, designation process, etc.  The end result is fewer Notified Bodies & Notified Bodies with narrower scopes after the designation process.  Also, with the nexus of  the EU regulations, Canada’s MDSAP requirements, and medical device manufacturers transitioning to ISO 13485:2016 the Notified Bodies resources are being strained which means less resources available to the medical device manufacturers. The limited resources means it may be a challenge to complete these processes without hitting the edge or past the transition period so start now or you may not be able to keep all your CE medical devices on the EU market in about 3 years from now when the clock runs out.

If you need help with your EU MDR or IVDR transition planning please email Leo Eisner at Leo at EisnerSafety dot com, or call Leo at +1 (503)-244-6151. He is the Principal Consultant of Eisner Safety Consultants.

If you are reading this post my guess is you already know the proposed MDD regulations are contentious and that there is some major changes proposed some good and some not so good. 

The later occurred a couple weeks ago when the Rapporteur Mrs. Roth-Behrendt proposed in a draft report for the MDD regulations.  As Eucomed states “The draft report is a step backward for patients, healthcare systems and Europe.”  The reason is the report calls for “a shift towards a centralised pre-market authorisation system which if carried through to the final legal text will confront patient in Europe with unnecessary delays of lifesaving medical devices reaching them without improving safety.”  The system would create a “enormous bureaucratic system with no benefits.”   Note, this is not a final report so there is a ways to go before we know if this will be finalized as is or modified. 

To get more information and perspective from these organizations please read on the posts and articles: Erik Vollebregt excellent article on the draft report detailing what the changes are; a Guest blog post on Erik Vollebregt medicaldeviceslegal website titled “no enhanced patient safety resulting from rapporteur Roth-Behrendt’s proposal”; Eucomed’s position and understanding of the Rapporteur ‘s draft report; a blog post by the CEO of MedTech Europe, EDMA, & Eucomed in regard to draft report for the MDD; MedTech Europe story on “European Parliament’s ENVI Committee releases draft reports on MDD and IVDD; and Where the EU system for medical devices is and needs to go.

We hope these articles help you understand where the process stands and help you form your own opinions.  From there where you go is up to you but know we will keep sending you updates on this process as we find relevant information to pass on as this process is critical to the survival of the European Medical Device Market.