The European Medical Device Regulations are due to be published in their final form late 2016 to early 2017. The draft regulations that have been shared include a requirement in relation to manufacturers completing a Periodic Safety Update Report (PSUR) for devices with classifications of IIa, IIb, and III.
These PSURs summarise the outcomes of the manufacturer’s post-market surveillance required by Annex IIa together with a justification and description of any corrective or preventative actions taken. They will be made available electronically to all interested parties including the general public.
Manufacturers of class IIb and III devices will be required to update the report at least annually. Manufacturers of class IIa medical devices will be required to update their PSUR when necessary and at least every 2 years.
Manufacturers of class III devices or implantable devices will also be required to submit their reports to their Notified Body. The Notified Body will then review the submission and any evaluation it makes along with details of any actions taken. The reports will then be available to the competent authorities through the electronic system.
The PSUR will require at least the following information
- Conclusion of the benefit/risk determination
- Main findings of the post-market clinical follow-up
- Volume of sales
- Estimate of the population that use the device
- Where practicable the frequency of use of the device
The details of how submissions will be made have not yet been finalised and the EUDAMED database is still being worked on. Once the regulations are published organisations will have 3 years in which to comply with them, it could be quite a busy time for all involved.
QCS International has the experience and knowledge to guide you through the initial steps to ensure your organisation submits PSURs correctly and timeously.