The Medical Device Coordination Group (MDCG) has released two very useful guidances: one concerning the application of IVDR requirements to “legacy devices” and devices placed in the market under IVDD, and a Q&A guidance on UDI under the In Vitro Devices and Medical Devices Regulations.
Starting with the first guidance on IVDR requirements, it addresses Article 110(3) of the In Vitro Devices Regulation (IVDR) 2017/746, giving clarity on the transition periods for the different IVDR classes (A sterile, B, C and D). It also states the main IVDR requirements for legacy devices, which are the following:
- Post-Market Surveillance (PMS) system based on a PMS plan as per Articles 78 and 79 IVDR;
- Post-Market Performance Follow-Up (PMPF) requirements, to be included in the PMS as per Annex XIII, Part B, IVDR;
- Requirements and procedures related to serious incidents and field safety corrective actions, as well as to trend reporting, as per Articles 82 to 84 IVDR;
- PMS Report under article 80 IVDR (unless class C or D manufacturers that can voluntarily prepare a PSUR under Article 81 IVDR);
- General obligations for manufacturers (Article 10(9) & (11-14)), authorised representatives (Article 11(3)(c)–(g) + 11(1)(7)), importers (Article 13(2, second subparagraph, and (4), (6)-(8), (10)), and distributors (Article 14(2), last subparagraph, (4)-(6)).
The MDCG however outlines that the economic operators can ”follow any IVDR requirements also for legacy devices, especially if they deal with both ‘legacy devices’ and IVDR devices and want to apply the same procedures for all devices.”
Moreover, regarding devices placed on the market under the IVD Directive 98/79/EC (also referred to as “old” devices), it is worth mentioning that Articles 82 to 84 (on reporting and analysis of serious incidents and field safety corrective actions) and 85 to 95 IVDR (stating the obligations of competent authorities on market surveillance activities) are also applicable to these devices.
Finally, the guidance provides a table in its Annex that further clarifies the above-mentioned requirements and indicates under which conditions they are applicable to legacy devices.
On the other hand, the Q&A guidance on UDI under IVDR & MDR provides insightful answers to several questions related, among others, to:
- Basic UDI-DI;
- UDI Labelling;
- UDI rules for Systems and Procedure packs (SPSS);
- UDI and EUDAMED
- Where the number of items in a device package changes, is a new UDI–DI assignment required?
- Are the UDI–DIs of single–use reprocessed devices the same as the original devices?
- Where does the UDI carrier need to be placed on the label?
- How should UDI requirements be applied to kit components?
- Do manufacturers need to report the UDI–PI to the Eudamed database?
You can find these and other relevant guidances for your devices in our MDlaw Library.
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