Medical Device Webinar: Current Information about the Medical Device Regulation
On the 17th of March 2020, the EU Parliament voted for a one-year delay of the Date of Application (DoA) of the medical device regulation EU MDR 2017/745 to 26 May 2021. This change was accepted by the Council on the 22nd of April pushing the process further for the official publication in the Official Journal on 25th of April.
EU MDR was published on the 5th of May 2017 with a planned DoA on 26 May 2020. This is the only date which is postponed, enabling all stakeholders to gain back the lost time due to the COVID-19 crisis and ensuring continuity of the healthcare system during this challenging period.
All other dates listed in Article 120 of the EU MDR remain unchanged. So, the certificates in accordance with Directives 90/385/EEC and 93/42/EEC will, as initially planned in EU MDR, become void at the latest on 27 May 2024. This date will remain the same even though the DoA is now postponed till 26 May 2021 allowing ongoing renewal of certificates to continue one more year and enabling the introduction of significant changes based on the old legislation rules to have a reasonable chance in the crisis situation.
Dr. Sabina Hoekstra and Dr. Bassil Akra from TÜV SÜD Product Service GmbH will use this webinar to share with you their thought on this delay and present to you the pros and cons associated with the whole change of timelines. Delays are not always positive and may include surprises that we typically don´t like, attend and learn more about the impact of this change to your ongoing activities.
If you want to register for the Webinar "Postponement of the MDR", please fill in the form on this page.
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Bosnia and Herzegovina