Europe: New MDR Compliance Guidance for Legacy Medical Devices Has Been Released by Authorities

ARQon
Dec 17, 2021
2 min read

Medical Device Coordination Group (MDCG) has published a new guidance on application of MDR requirements to ‘legacy devices’ and to devices placed on the market in accordance with Directives 90/385/EEC or 93/42/EEC. The MDCG has released a report and guidance as a result of a task force's investigation into how to successfully use transitory provisions for legacy medical devices that were certified and commercialised in Europe prior to the MDR's applicability date of 26 May 2021. The discussion was focused on three points below:

Application of requirements set out in Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) to ‘legacy devices’
Application of other MDR requirements to ‘legacy devices’
Application of MDR requirements to ‘old’ devices

Application of requirements set out in Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) to ‘legacy devices’ Legacy devices will be subject to post-market surveillance, market surveillance, and vigilance obligations under MDR Chapter VII. When it comes to Notified Body (NB) obligations to conduct proper surveillance of legacy devices, the guideline advises NBs to be flexible when considering these requirements. According to MDR Article 86, legacy devices must provide periodic safety update reports (PSURs), which include making PSURs available to Competent Authorities upon request and delivering PSURs to their NBs during surveillance audits.

Application of other MDR requirements to ‘legacy devices’

Other MDR criteria should be applied to legacy devices, according to the MDCG guidance. Post-market and market surveillance, vigilance, and registration of both economic operators and devices are all part of the requirements.

MDR compliance is required by general obligations for manufacturers and importers (in particular, Articles 10(1) and 13(1)). Nevertheless, MDR compliance for legacy devices includes compliance with either the MDD or AIMDD, as well as MDR Article 120 criteria (3).

Application of MDR requirements to ‘old’ devices

MDR requirements should not apply to devices put on the EU market until May 26, 2021. Old devices, on the other hand, are covered by MDR Articles 93 to 100, which deal with Competent Authorities' market monitoring rights and obligations. This allows competent authorities to assess that those devices are in compliance with the standards in effect at the time they were placed on the market and to take appropriate measures against non-compliant or unsafe devices.

According to the guidance, a separate MDCG market surveillance working group will give additional clarification about the practical implementation of market surveillance for obsolete devices.

Sources:

MDCG 2021-25 Regulation (EU) 2017/745 - application of MDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC