What’s Trending in Medical Device Legislation?
Since the publication of the new EU MDR, discussions on the potential impact of the new regulations has been ongoing. After an initial delay due to the COVID-19 pandemic, the MDR entered into force in May this year. Although the EU Commission has issued a long list of guidance documents to facilitate the implementation, uncertainties remain as to how, in real life, the Notified Bodies and regulatory agents would implement the regulations.
The below provides a summary of some key points currently being discussed at conferences across the medical device sector.
Under the new MDR, Notified Bodies will be audited jointly by the local Competent Authority, representatives of the European Commission, and another member state Competent Authority. Annex VII sets out requirements to be met by Notified Bodies. In addition, all Notified Bodies will be subject to monitoring and re-assessment. Stricter rules on designation of Notified Bodies may reduce the number of existing Notified Bodies. According to an expert speaker at the RAPS conference, most of the Notified Bodies are currently at their full capacity. It would be harder for medical device companies to launch new products if there is a reduction in the number of Notified Bodies, not to mention the prolonged waiting time. On the other hand, there are 5 new Notified Bodies designated for in-vitro diagnostic devices under the IVDR which is good news for IVD companies. However, it is still suggested that companies should act quickly to contact Notified Bodies. One piece of advice that was given, again and again, is to keep in touch with your Notified Bodies for the most up to date information.
The development of EU harmonized standards is another key part of the regulatory compliance world. Since March 2020, there are 264 standards harmonized with the MDD 93/42/EEC and 41 standards harmonized with the IVDMDD 98/79/EEC. Now that we have come to the end of the transition period for MDR, and with only 1 year from the implementation of IVDR, the list of new harmonized standards is expected to be published soon. Under Standardization Request M/575, there are 201 standards to be amended or revised and 27 standards to be drafted for MDR; 46 standards to be amended or revised and 3 standards to be drafted for IVDR by the end of May 2024.
UK legislation post Brexit is also worth discussing as it ties so closely to EU legislation. From 1 January 2021, the UKCA marking has replaced EU CE marking in Great Britain, however, the CE marking will still be recognized until 2023 for medical devices. Northern Ireland continues to use CE marking.
In terms of medical device legislation, the current UK Medical Device Regulation 2002 (UKMDR) which is a direct transposition of the EU Medical Device Directive (MDD) will continue to apply in Great Britain. Therefore, the UK requirements would divert from the EU rules from the enforcement of EU MDR. The UK published the Medicines and Medical Device Act 2021 in early February. The Act granted direct powers to the Secretary of State for Health to update the existing regulatory frameworks in the fields of human medicines, veterinary medicines and medical devices. It will be interesting to see if the authorities will introduce any changes to the current regulation to be in line with EU MDR.
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