This post is based on the Impact of the Draft report on the EU MDD proposed regulations and comes from posts, opinion pieces and stories from MedTech Europe, Eucomed & Erik Vollebregt (medicaldeviceslegal.com)
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.