We are reaching key milestones on the road to EU Medical Device Regulation (MDR) implementation for legacy devices!
Regulation (EU) 2023/607 of 15 March 2023 amended Regulation (EU) 2017/745 for the transitional provisions for certain medical devices to give Notified Bodies (NB) the time to carry out their conformity assessments and avoid shortages of devices. The figure below describes the deadlines for legacy devices that can benefit from this extended transitional period. These legacy devices may still be placed on the market/put into service until the given deadlines.
At Archer Research, as specialized Medical Device CRO, we understand the EU MDR clinical requirements and deadlines, and we are there to advise and guide our clients. Herewith we would like to highlight key points that should be considered when preparing for the transition. Not only for our clients, but for all manufacturers:
The NB conformity assessment process under MDR after submission of application can take approximately 18 months.
The technical documentation required for the conformity assessment procedure for certain medical devices must include, among other documentation, sufficient clinical evidence resulting from post-market surveillance and clinical follow-up (PMCF) data.
Setting-up a clinical study and obtaining the necessary authorizations (which may vary depending on the study design and Member State in which the study is being performed) can take several months, and manufacturers are advised to plan for clinical data collection in time.
With extended expertise in the medical device industry, Archer Research can help manufacturers evaluate their gaps in clinical evidence and provide support to design and conduct studies that meet their needs in a timely-manner, while ensuring cost-efficiency.
Delayed submissions could lead to significant administrative complications and risk of shortages of devices on the market.
Get in touch
If you have questions, concerns, need advice about the EU MDR clinical requirements or need a partner to set up and manage your clinical study, feel free to contact us to find out how Archer can support you in your journey:
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