The Medical Device Coordination Group has issued two very useful guidances for importers and distributors on repackaging and relabelling activities under MDR and IVDR as well as a guidance on the requirements for legacy devices under the MDR.
In this sense, the first Q&A guidance (MDCG 2021-26) gives more clarity on repackaging and relabelling under article 16 of both IVDR and MDR. Thus, this document is of great relevance for importers and distributors, as it provides with explanations the activities that can be performed without implying a modification of the device, which are namely the following as per article 16(2):
- Supplying information and translation of information (including IFUs) so the product can be placed in the market of an specific Member State. This is referred as “relabelling”.
- Applying changes to the outer package of a device already placed in the market in order to place it in the market of a Member State. This is referred as “repackaging”.
Therefore, the questions covered focus, among others, on the following points:
- The application of article 16(3) and (4) to MDR legacy devices
- The possible requirements for market the device in a Member State
- Whether dividing large quantities of devices is considered relabelling nor repackaging as per Article 16(2)
- The information that should be notified to the manufacturer as per art. 16(4), stating a timeline of 28 days prior to making the device available on the market.
- What information should be notified to Competent Authority by distributors and importers who perform those relabelling and/or repackaging activities as per art. 16(4) and what conditions they shall notify to the manufacturer and competent authority.
- The need of a notified body review and certification when performing repackaging and relabelling activities and for which class this is required.
More information on article 16 can be found in the following guidance as well as in MDlaw Library.
On the other hand, the second guidance (MDCG 2021-25) refers to the position taken by the ad-hoc task-force, a group created by the MDCG to discuss the topic of MDR requirements that apply to legacy and ”old” devices.
The Guidance states that as of 26 May 2021 the following MDR provisions apply to legacy devices:
- Article 120(3)
- Articles 85 and 86
- Provisions applicable for economic operators of legacy devices:
- For manufacturers: Article 10 (10), (12)–(15);
- For authorised representatives5: Article 11(3)(c)–(g);
- For importers: Article 13(2), 2nd subparagraph, (4), (6)–(8), (10);
- For distributors: Article 14(2), last subparagraph, (4)–(6);
Furthermore, this document also explains the general non-applicability of MDR requirements to devices placed on the market prior to 26 May 2021 (the so-called “old” devices), however, MDR Articles 93-100 do apply. As well as how system and procedure packs should be treated, e.g. if they consist of only legacy devices, MDR Article 22 does not apply. For further clarification, Annex to the Guidance contains a non-exhaustive list of all the MDR requirements that are applicable or not to legacy devices.
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