The EU MDR 2017/745 was published in May 2017 with a transition period of three years which was extended by one additional year to address COVID 19 restrictions and limitations.
This additional year was taken away from the predefined grace period in Article 120 of the EU MDR 2017/45. During the grace period, which will end in May 2024, manufacturers are still allowed to place devices certified under the Medical Device Directives to the Union Market.
With approximately 2 years to go till the end of the grace period, manufacturers and notified bodies are under growing time pressure to move devices from the old Directives to the EU MDR 2017/745.
This move is leading to a lot of issues which are connected to capacity limitations, continuous new interpretations, and administrative burdens.
After more than 4.5 years after publication of the regulation just 50% (n=27) of the notified bodies who applied (n=54) to be designated and notified for the new regulation were successful and are enabled now to perform their task under the new legislative framework.
Nevertheless, just 10% of these notified bodies hold a full scope of designation.
More than 90 guidance documents were published since the publication of the regulation to explain the meaning of the legal text, leading to new interpretation in a continuous manner and impacting already running conformity assessment processes critically. Common specifications which are essential for the system are still under preparation. Voluntary consultation process to address the missing pre-assessment elements and technical meeting services of notified bodies is not available.
During this annual Medical Device conference, keynote speakers from the various sectors will share their views, current experiences, and recommendations towards a smoother implementation of the EU MDR 2017/745.
|27 September 2022|
|Welcome from the Scientific Board|
|Impact of the EU Regulations on the daily work of Competent AuthoritiesThomas W. Møller – Director of Medical Devices at Danish Medicines Agency|
|European MDR update – Status of implementationDario Pirovano – Senior Regulatory Adviser at MedTech Europe|
|Capacity of Notified BodiesSabina Hoekstra-van den Bosch – Regulatory Strategy Principal at TÜV SÜD|
|First Experience with EU MDR Certification – are we there yet?Elizabeth Gfoeller – Corporate Director, Regulatory Affairs at MED-EL Elektromedizinische Geraete GmbH|
|Lessons Learned with MDR Consultation RequirementsBassil Akra – Chief Executive Officer at AKRA TEAM GmbHArkan Zwick – Corporate Regulatory Affairs Director at CROMA Pharmaceutical, Austria|
|Compliance in the Grace Period – Balancing MDD vs. MDRPhilippe Auclair – Senior Director, Regulatory Strategy and Advocacy at Abbott Quality and Regulatory|
|How to ensure better Readiness of your Application?Gert Bos – CSO at Qserve Group|
|Round Table: What? When and How?|
|All day long||Meet-the-Experts one-on-one slots: MDR State of the Art & Medical Writing|
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