New MDCG Guidance documents released

October 21st and December 9th, 2021, new guidance documents were released by the Medical Device Coordination Group (MDCG). These new documents provide clarification on the 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 (MDCG 2021-25), address questions and answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (MDCG 2021-26) and on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 (MDCG 2021-27), and provides guidance with regards to substantial modifications of clinical investigation under Medical Device Regulation (MDCG 2021-28).

MDCG 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.

This guidance addresses the applicability of MDR requirements to “legacy devices” and “old” devices. Legacy devices have been defined as devices, which, in accordance with Article 120(3) of the MDR, are placed on the market after the MDR’s date of application (DoA) and until 26 May 2024 if certain conditions are fulfilled. Old devices have been defined as 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.
Through this guidance the MDCG clarifies that the MDR’s post-market surveillance, market surveillance, and vigilance requirements apply to legacy devices. The guidance also specifically addresses the application of Article 86 MDR on the periodic safety update report (PSUR), and states that manufacturers of “legacy devices” are subject to the requirement to draw up and update PSURs in accordance with the aforementioned MDR Article.
In addition, also other MDR requirements should apply to “legacy devices”, provided that those requirements relate to post-market surveillance, market surveillance, vigilance, registration of
economic operators and devices. MDR requirements that are not related to these topics should in principle not apply to economic operators in respect to “legacy devices”. However, the market surveillance activity requirements of the MDR do apply to “old” devices.

MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

The questions and answers 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 MDR/IVDR concerning relabelling and repackaging of devices. It is noted that Article 16(2), (3) and (4) of the MDR/IVDR 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.

Some of the questions addressed in this document are the following:
• Do Article 16(3) and (4) of the MDR apply to “legacy devices”?
• Is the splitting-up of large quantities of devices in shipping containers into smaller quantities of devices in packages or individual units covered by Article 16(2)?
• What information should be notified to the manufacturer according to the Article 16(4)?
• What information should be notified to the competent authority according to the Article 16(4)?
• To which notified bodies may importers and distributors apply to obtain the certification referred to in Article 16(4)?
• In the case of translation of the IFU, is it necessary to keep the original version of these instructions in the packaging?

MDCG 2021-27 Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.

The questions and answers covered by this document aim to provide further detail on the operational and practical implementation of Articles 13 and 14 and other related obligations for importers and distributors under the MDR/IVDR.
This guidance deals with topics such as the distinction between importers and distributors, the general obligations of these economic operators as well as the specific verification and registration obligations. The guidance also offers several practical examples of different situations involving the import or distribution of medical devices and IVDs.

MDCG 2021-28 Substantial modification of clinical investigation under Medical Device Regulation

Under the MDR, the sponsor of a clinical investigation is required to notify the Member State(s) in which a clinical investigation is being, or is to be, conducted if it intends to introduce modifications to a clinical investigation that are likely to have a substantial impact on the safety, health or rights of the subjects or on the robustness or reliability of the clinical data generated by the investigation, within one week, by means of EUDAMED. However, as EUDAMED is not yet fully functional, MDCG has created a series of clinical investigation application/notification documents to support clinical investigation procedures with respect to MDR until EUDAMED is ready.

The guidance however states that it is important to check with the individual Member State in which the clinical investigation is taking place or planned to be conducted as to any specific national requirements that may apply. It also adds that this template will be withdrawn once the EUDAMED module for clinical investigations is fully functional.

What does this mean to you?

MDCG 2021-25 provides relevant insights into the applicability of the MDR to “legacy” devices and “old” devices. Despite only addressing the MDR a similar interpretation could be made for the IVDR.
MDCG 2021-26 and 27 answer relevant questions with regards to repackaging and relabelling of devices and tackles some of the key questions with regards to importers and distributors.
MDCG 2021-28 contains a practical form for the notification of substantial modifications of a clinical investigation under the MDR.

Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.

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