What new changes have been made to the EU MDR Transition Period?
The changes include, subject to certain conditions, an extension of the transitional period for higher-risk devices, such as pacemakers, to comply with EU MDR requirements until December 31, 2027. Subject to certain conditions, the transitional period for medium and lower-risk devices, such as syringes, has been extended until December 31, 2028. These changes apply automatically in Northern Ireland under the terms of the Northern Ireland Protocol.
Certificates issued by notified bodies under Directives 90/385/EEC and 93/42/EEC from May 25, 2017 and still valid on May 26, 2021 have also been extended until the end of the relevant transition period, depending on device class. This extension applies to certificates that expired before March 20, 2023, if certain conditions are met, and to certificates that were due to expire after March 19, 2023, but now expire at the end of the relevant transition period. These extensions are automatically applied in Northern Ireland, and certificates that have been extended will be recognized as valid for placing CE marked devices on the GB market.
How MDR Extension Effect on Medical Device Sales in the UK?
The MHRA’s Chief Healthcare Quality and Access Officer, Dr Laura Squire, welcomed the changes, stating that the priority is to ensure that patients have safe access to medical devices. The medical device industry has been concerned about certificate expiration, but EU changes to renewals mean that supply to the UK can continue for many manufacturers without the need for an exceptional use authorization. The MHRA will update its registrations guidance to reflect these changes.
So, Instead of procrastinating obstacle of EU MDR, Device manufacturers can really use this as an opportunity to create marketing advantage by developing a competitive edge and hastening to be EU MDR compliant in order to acquire the best advantage in this cutthroat industry.
Operon Strategist is here to assist you in overcoming all of these challenges and becoming the market leader by embracing the grace of becoming EU MDR compliant. Operon Strategist is a medical device regulatory consulting firm that works with various regulatory bodies to provide regulatory services to clients. In addition, we assist medical device manufacturers in obtaining CE Marking Certification for their products. Also, we are a medical device regulatory consultant and assist in CDSCO medical device registration in India.
Reference: https://www.gov.uk/government/news/extension-of-ce-certificates How
