MDCG updates October 2021

The Medical Device Coordination Group (MDCG) has published the following updates:

MDCG numberNotes
MDCG 2021-26Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746
This document presents questions and answers about obligations introduced by Article 16(2) to (4) under Regulation (EU) 2017/745 on medical devices (MDR and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). Reference to ‘the Regulations’ should be understood to cover both the MDR & IVDR.

Article 16 generally concerns cases in which obligations of manufacturers apply to importers, distributors or other persons.

The questions covered by this document aim to guide economic operators carrying out any of the activities mentioned in points (a) and (b) of Article 16(2) of the Regulations concerning relabelling and repackaging of devices.

It should be noted that Article 16(2), (3) and (4) of the Regulations do not apply to operators subcontracted by the manufacturer (that may also qualify as importers or distributors), who also carry out relabelling and/or repackaging activities on behalf and under the control of the manufacturer.
MDCG 2021-25Regulation (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
Having regard to the discussions of the MDCG meeting on 27/28 May 2021 on “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 set up an ad hoc task-force to further discuss this topic in order to quickly find a solution that is legally defendable and pragmatic. The outcome should guide the ongoing work on guidance documents, such as on PSUR and notified bodies’ appropriate surveillance.

Discussions were divided in three parts:
1) Application of requirements set out in Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) to ‘legacy devices’
2) Application of other MDR requirements to ‘legacy devices’
3) Application of MDR requirements to ‘old’ devices

Legacy devices should be understood as devices, which, in accordance with Article 120(3) of the MDR, are placed on the market after the MDR’s date of application (26 May 2021) and until 26 May 2024 if certain conditions are fulfilled.

‘Old’ devices are those devices that were placed on the market before 26 May 2021 in accordance with the AIMDD or the MDD or in accordance with the applicable rules before the Directives had entered into force.

With this document, the task-force reports back to the MDCG about its position on the applicability of MDR requirements to ‘legacy devices’ and ‘old’ devices. The annex contains a non-exhaustive table illustrating MDR requirements that should apply to ‘legacy devices’.
MDCG 2021-24Guidance on classification of medical devices
The purpose of this chapter is to provide a general overview on the impact of the classification of medical devices on different aspects of the device compliance with the legal requirements. The explanations provide some simplified concepts and are not exhaustive. For details see the MDR and related additional guidance.