EU Post Market Surveillance – Transitional Requirements for Medical Device Manufacturers
The transition of the medical device industry in the European Union to the Medical Device Regulations 2017/745 is now well underway. Thousands of manufacturers are now successfully certified to the new regulation, and more certifications are being issued each week.
There remain many more thousands of products which are still certified to the Medical Device Directive 93/42/EEC, which can continue to be legally sold whilst valid certification is maintained. Manufacturers of these products are however required and expected to adhere to the requirements of both the old directive, and certain aspects of the new regulations. This article helps manufacturers understand the requirements which apply to them, and how to practically meet them.
Who can use the transitional measures?
There are several reasons why manufacturers might still be legally able to sell products under previous Medical Device Directive certificates and approvals:
- They maintain valid notified body certification to the MDD. The expiry date is listed on the certificate itself, after which date product can no longer be legally sold into the EU.
- They have a device which is Class I self-certified, was validly CE Marked before May 2021, and has a new, higher risk classification under EU MDR which requires a notified body.
Recent proposals for update of the EU Medical Device Regulation increase the scope for manufacturers to use the transitional measures, which have now been approved. This allows manufacturers to keep selling product after existing notified body certification has expired, subject to certain provisions;
- If certification has already expired, obtain a valid exemption which has been authorised by an EU regulator, which allows them to continue selling a product without valid certification for a limited time.
- If certification has not expired, sign a contract with their notified body to begin the EU MDR certification process for the devices which are currently available under MDD certification.
Notified Body Expectations
As part of the surveillance and auditing activities of EU notified bodies, they will be looking at confirming continuing compliance to both the certified directive and of the relevant requirements listed in article 120 of EU MDR;
- Contracts are in place to cover the surveillance activities of the notified body during the transition period.
- Manufacturer quality management systems continue to be effective and are demonstrated to be so at notified body audits.
- Post market surveillance on the products is maintained, and the safety profile does not identify significant increases in observed harm, and no potential threats to patient and public health posed by the devices.
- Notified bodies are expected to consider the transition planning to EU MDR for the products, if they are not being discontinued, so will look to audit these plans.
Quality Management Systems
The quality management system must continue to address the requirements of the Medical Device Directive and demonstrate its effectiveness at meeting the regulatory requirements. In addition to this, the quality management system will also need to demonstrate through documented processes the requirements of Article 120 of EU MDR are met. This includes creation of MDR compliant post market surveillance documentation, vigilance reporting, and not making significant changes to the products.
Call out – Vigilance reporting timelines
Vigilance reporting timelines have been updated and reduced from a maximum timeframe of 30 days to a minimum of 15 days after first becoming aware of a serious complaint which could or has caused serious injury. Even stricter timeframes apply in certain cases where a death is potentially attributed to a medical device.
Call out – Significant Changes
Where using the transitional provisions, a stipulation is that “no significant changes to design or intended purpose” are authorised without the product achieving EU MDR certification. There is EU guidance published in this area.
Call out – Periodic Safety Update Reports
Periodic safety update reports (PSUR) will be required for all Class IIA, Class IIB and Class III devices under EU MDR. For Class IIB and Class III devices, these products should already have an approved PSUR, which requires further update and approval at least once per year thereafter. Class IIA devices are recommended to have a PSUR in place before 26 May 2023, 2 years after EU MDR came into effect.
A manufacturer will need to demonstrate to their notified body that they have effective quality management system processes for creating PSUR reports and performing any necessary analysis and remedial actions as part of routine audits.
Successfully navigating transition
Successfully navigating the transition requirements and meeting notified body expectations can be challenging, when considering resourcing constraints at manufacturers. The critical step is understand the transitional requirements outlined in Article 120 of EU MDR, updating the quality management system where necessary to address transitional requirements, and demonstrating compliance through documented records in advance of notified body surveillance audits.
Secondarily, keeping an eye on your MDD certificate expiration date and taking necessary actions needed for extension of certification validity.