Post Market Surveillance (PMS) under the new MDR
-by Dalia Givony-
MDR (Medical device regulation, 2017/745/EU) was entered into force on May 25th 2017 with 3 years transition period for medical devices. Due to Covid-19 pandemic the due date for compliance was pushed back a year to May 26th, 2021.
Legacy medical devices that holds a certificate from the Notified Body (NB) may still be placed on the EU market until May 26th, 2024 as long as the European Medical Device Directive (93/42/EEC) certificate is valid.
Nevertheless, manufacturers must comply with the new PMS requirements as specified in the MDR by May 26th, 2021 even if they continue placing a legacy device under a valid MDD certificate.
What does it mean?
PMS requirements are defined in MDD and ISO 13485:2016. Manufacturers which comply with these requirements probably already have established a system for compliance with PMS requirements. Yet MDR Chapter VII (Post-market surveillance, vigilance and market surveillance) and Annex III (Technical documentation on post-market surveillance) defines new risk-based PMS requirements and enforcement method proportionally related to device class. Manufacturers need to ensure a robust PMS system is in place to pass the Notified Body and the Competent Authorities scrutiny.
According to MDR PMS system must consist of:
1. Procedures as part of the quality system to control the PMS activities.
2. PMS plan: The plan shall describe a proactive and systematic process to collect and analyze PMS data in order to confirm device quality, safety and performance throughout the life cycle of the device. The process shall also allow a comparison between the device and similar products available on the market.
3. PMS activities: Manufacturer must consider various activities to collect data such as:
· Vigilance- complaints handling, trend reports
· Proactively collecting customer feedback
· CAPA, Field Safety Corrective Action
· Collection of new data from the literature or databases to identify new risks, information on device performance as well as on similar devices.
4. PMS Report (for Class I) or PSUR (Periodic Safety Update Report for class IIa, IIb, III) shall summarize the results and conclusions resulting from the PMS activities together with a rationale and description of any preventive and corrective actions taken. PMS Report (class I devices) shall be updated when necessary and made available to Competent Authorities upon request. For class IIa PSUR should be updated at least every two years. For class IIb and class III PSUR should be updated at least annually. Manufacturers of class IIa and class IIb should make the PSUR available to the notified body involved in the conformity assessments. Manufacturers of class III devices or implantable devices, shall submit the PSURs to the NB via EUDAMED.
5. An alignment between PMS Report/ PSUR and other QMS documents must be maintained. For example, the CER (Clinical Evaluation Report) must be updated, risk management file should be updated with new risks or with new rate of already identified risk, Instruction for Use must be updated with new residual risks.
MDR defines new PMS requirements for medical device manufacturer. Compliance must be demonstrated by 26th May 2021 for all classes, even if compliance to MDD is still declared. It is advised to conduct a gap assessment to identify the required activities to bring an MDD compliant system with the new PMS requirements.
Need assistance understanding PMS requirements or manage your PMS system?