Post market surveillance in Europe
One of the changes in the new European Medical Devices Regulation (MDR 2017/745) is the strengthened post market surveillance requirements for medical device manufacturers in order to register their product in the European Union. This requires manufacturers for each medical device to plan, establish, document, implement, and maintain a post market surveillance in accordance to the risk class and the type of the medical device. This post market surveillance will also ensure an active and systematic recording and analysis of data with regards to the quality, safety, and performance of the medical device throughout its lifetime. This active and systematic approach will also help in drawing conclusions and establishing necessary preventive and corrective actions.
From the post market surveillance plan, the new European Medical Device Regulation requires manufacturers the following:
Post market surveillance report (for class I devices) :
which contains the summary and conclusion of the analysis of the gathered post market surveillance data, including rationale for any corrective and preventive actions (CAPA) taken. The report shall be updated when necessary.
Periodic safety update report (PSUR) (for class IIa, IIb, and III) :
which also contains the summary and conclusion of the analysis of the gathered post market surveillance data, including rationale for any corrective and preventive actions (CAPA) taken. The PSUR shall be set out for the entire lifetime of the medical device and must be updated at least every two years for class IIa and at least yearly for class IIb and III. The periodic safety update report (PSUR) shall be part of the technical documentation and must be made available to notified bodies and competent authorities.
These reports shall also include:
- Benefit-risk determination conclusion
- Findings of post-market clinical follow-up
- Sales volume of the medical device, evaluation of size and characteristics of population using the medical device, and frequency of use of the medical device
Vigilance: Report on serious incidents and field safety corrective actions :
includes report on serious incidents involving the medical device made available on the European Union market except side effects already documented in the product information. This also includes any field safety corrective action (FSCA) on medical devices made available on the European Union market, including FSCA undertaken in the third country on a device legally available in the European Union market.
The severity of the serious incident determines the timeframe of the reporting: 2 days, 10 days or 15 days after the manufacturer becomes aware of the incident.
Trend reporting :
includes report on a significant increase in the severity or frequency of non-serious incidents or expected side effects that may have significant effect on the benefit-risk analysis, and which may lead unacceptable risks over benefits when it comes to the health and safety of patients or users of medical devices. Manufacturers are required to specify how these incidents are managed and to identify the methods used in determining the significant increase of such incidents.
Analysis of serious incidents and field safety corrective actions :
after reporting, manufacturers are required to conduct investigations on serious incidents of the concerned medical device. The analysis shall include risk assessment and field safety corrective action. Manufacturers must work with competent authorities and notified bodies regarding the investigations.
See here our service for the European Medical Device Registration.