The Medical Device Coordination Group (MDCG), the expert panel of the EU Member States and the EU Commission, has released on 20 October 2021 two guidance documents which provide meaningful guidance (1) for manufacturers, importers and distributors of “legacy devices” on which MDR obligations they must comply with (guidance document 2021-25), and (2) on the obligations of parallel importers regarding the repackaging and relabeling of medical devices under Article 16 MDR/IVDR (guidance document 2021-26).
In more detail
Under Art. 120(3) of Medical Device Regulation 2017/745 (MDR) provides that certain devices certified under the prior Medical Device Directives 93/42/EEC or 90/385/EEC (so-called “legacy devices”) may, for a transitional period, continue to be placed on the market after the date of application of the MDR on 26 May 2021 without being certified under MDR, provided, however, that the MDR rules regarding surveillance and vigilance be complied with. As many devices still rely on this transitional mechanism, the question which surveillance and vigilance obligations specifically must be complied with by importers and distributors of such legacy devices is critical.
In guidance document 2021-25 (“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”), the MDCG provides its opinion on this issue. The document contains detailed guidance particularly to which extent periodic safety update reports (PSURs) must be created and submitted. The MDCG also opines that manufacturers of legacy devices do not need to appoint a Person Responsible for Regulatory Compliance (PRRC) for legacy devices – a surprisingly lenient opinion which counters the previously prevailing stricter view that a PRRC, being a surveillance and vigilance-related function, was also necessary for legacy devices. Manufacturers, but also importers and distributors, of such legacy devices should carefully assess their current processes in light of this new guidance and adapt as necessary.
With respect to the parallel import of medical devices, the MDCG has provided additional questions and answers regarding the repackaging and relabelling of the devices (guidance document 2021-26 titled “Questions and answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746”; see also the New guidance on translation of labels and repackaging of medical devices). Among other guidance for parallel importers, the MDCG opines that Art. 16(3) MDR/IVDR which require the parallel importer to notify the original manufacturer does not apply to legacy devices. However, it should be noted that this guidance does not address whether parallel importers of legacy devices must nonetheless notify the trademark-holding original manufacturer under the ECJ trademark case law for medicinal products. Therefore, original manufacturers are advised to establish and maintain robust procedures to monitor, and take enforcement action against non-compliant or trademark-infringing, parallel trade of their medical devices.