October 25, 2021
The European Commission’s Medical Device Coordination Group (MDCG) has published new guidance pertaining to Medical Devices Regulation (MDR) compliance for legacy devices already sold in the European Union.
EU MDR compliance for legacy devices
The MDCG has issued a report and guidance stemming from a task force’s examination of how to effectively apply transitional provisions for legacy medical devices that have been certified and commercialized in Europe prior to the MDR’s May 26, 2021 date of application.
The MDCG task force focused on three key issues:
- Applying MDR Chapter VII requirements to legacy devices
- Applying other MDR requirements to legacy devices
- Applying MDR requirements to “old” devices—those placed on the EU market according to Medical Devices Directive (MDD) 93/42/EEC or Active Implantable Medical Devices Directive (AIMDD) 90/385/EEC, before the MDR took full effect
Task force recommendations regarding these issues have now been incorporated into the MDCG guidance for legacy devices.
MDR Chapter VII and legacy devices
In terms of MDR Chapter VII, requirements for post-market surveillance, market surveillance and vigilance will apply to legacy devices. Regarding Notified Body (NB) obligations to perform appropriate surveillance of legacy devices, the guidance recommends flexibility for NBs when it comes to reviewing these requirements.
The guidance also covers periodic safety update report (PSUR) requirements for legacy devices according to MDR Article 86; legacy devices are subject to PSUR requirements, including making PSURs available to Competent Authorities upon request as well as providing PSURs to their NBs during surveillance audits.
“Other” MDR requirements for legacy devices
The MDCG guidance also recommends application of other MDR requirements to legacy devices. These requirements involve post-market and market surveillance, vigilance and registration of both economic operators and devices.
General obligations for manufacturers and importers require conformity with MDR (Articles 10(1) and 13(1), in particular); for legacy devices, however, MDR conformity entails conformity to either the MDD or AIMDD as well as to requirements laid out in MDR Article 120(3).
“MDR requirements that are not related to post-market surveillance, market surveillance, vigilance, registration of economic operators and devices should in principle not apply to economic operators in respect to ‘legacy devices,’” states the guidance.
MDR requirements for “old” devices
Last, the MDCG guidance notes that in general, MDR requirements should not apply to old devices placed on the EU market prior to May 26, 2021. MDR Articles 93 to 100 pertaining to Competent Authorities’ market surveillance rights and obligations, on the other hand, do cover old devices.
“This allows competent authorities to check that those devices are in conformity with the rules applicable at the moment when they were placed on the market and to take appropriate measures against non-compliant or unsafe devices,” the guidance states.
A separate MDCG market surveillance working group will issue further clarification regarding practical application of market surveillance for old devices, according to the guidance.
Legacy device manufacturers and other economic operators should refer to the full MDCG guidance document for further details on their compliance obligations under the MDR.