The EU Medical Device Regulation (MDR, 2017/745/EU) came into force on May 25th, 2017.
Legacy medical devices that comply with the Medical Device Directive (MDD, 93/42/EEC) and are covered by a notified body certificate may benefit from the MDR transition timeline extension published in 2023 by the European Union. The transition deadline for Class III and IIB implantable devices has been extended to December 2027, while the transition for Class IIB non-implantable devices, Class IIA, and Class I sterile/measuring devices, as well as devices requiring notified body involvement for the first time under MDR, has been extended to December 2028.
However, manufacturers must comply with the new Post Market Surveillance (PMS) requirements specified in the MDR by May 26th, 2021, even if they continue placing a legacy device under MDD.
What does this mean?
Post Market Surveillance (PMS) requirements are defined in the MDD and ISO 13485:2016. Manufacturers complying with these requirements likely already have a system for PMS compliance. However, MDR Chapter VII (post-market surveillance, vigilance, and market surveillance) and Annex III (Technical documentation on post-market surveillance) introduce new risk-based PMS requirements and enforcement methods proportional to the device class. Manufacturers need to ensure a robust PMS system is in place to pass scrutiny from Notified Bodies and Competent Authorities.
According to the MDR, the PMS system must consist of:
Procedures as part of the quality system to control PMS activities.
PMS plan: Describing a proactive and systematic process to collect and analyze PMS data, confirming device quality, safety, and performance throughout the device's life cycle. The process should also allow a comparison between the device and similar products on the market.
PMS activities: Manufacturers must consider various activities to collect data, including vigilance (complaints handling, trend reports), proactive collection of customer feedback, CAPA, Field Safety Corrective Action, and collection of new data from literature or databases to identify new risks and information on device performance.
PMS Report (for Class I) or PSUR (Periodic Safety Update Report for Class IIa, IIb, III): Summarizing results and conclusions from PMS activities with a rationale and description of any preventive and corrective actions taken. Reports should be updated as necessary and made available to Competent Authorities upon request. For Class IIa, PSUR should be updated at least every two years, and for Class IIb and Class III, at least annually. Manufacturers of Class IIa and Class IIb should make the PSUR available to the notified body involved in conformity assessments. Manufacturers of Class III devices or implantable devices should submit the PSURs to the NB via EUDAMED.
Maintaining alignment between PMS Report/PSUR and other QMS documents, such as updating the Clinical Evaluation Report (CER), risk management file, and Instruction for Use with new risks or with a new rate of already identified risks.
Conclusion:
MDR introduces new PMS requirements for medical device manufacturers. Compliance must be demonstrated by May 26th, 2021, for all classes, even if compliance with the MDD is still declared.
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