As most IVD manufacturers will know, a derogation to the IVDR was passed earlier this year which allows for a stepped transition in accordance with Article 110(3) of the IVDR. This allows for General IVDs registered under the IVD Directive which will require Notified Body intervention under the Regulation an extended transition period. However, there are some terms and conditions to consider, these being the Regulation requirements on:
- Post-Market Surveillance.
- Market Surveillance.
- Registration of Economic Operators and Devices.
However, there is some confusion on which other requirements will apply to these legacy devices. MDCG 2022-8 aims to dispel these doubts. Here we provide an excerpt from the guidance on the applicable requirements to legacy devices:
| IVDR Requirement | Application to IVD Legacy Devices |
| Art. 10(9), (11)-(14) – manufacturers’ obligations | YES (nota bene: ‘conformity with the requirements of this Regulation’ for ‘IVD legacy devices’ means conformity with the IVDD and the additional requirements in accordance with Article 110(3) IVDR) |
| Art. 11(3)(c)-(g), (7) – authorised representatives | YES (nota bene: ‘conformity with the requirements of this Regulation’ for ‘legacy devices’ means conformity with the IVDD and the additional requirements in accordance with Article 110(3) IVDR) |
| Art. 13(2), 2nd subparagraph, (4), (6)-(8), (10) – importers obligations | YES (nota bene: ‘conformity with the requirements of this Regulation’ for ‘IVD legacy devices’ means conformity with the IVDD and the additional requirements in accordance with Article 110(3) IVDR) |
| Art. 14(2), last subparagraph, (4)-(6) – distributors’ obligations | YES (nota bene: ‘conformity with the requirements of this Regulation’ for ‘IVD legacy devices’ means conformity with the IVDD and the additional requirements in accordance with Article 110(3) IVDR) |
| Art. 15 – person responsible for regulatory compliance | NO |
| Art. 16(3) and (4) – repackaging and relabelling | NO |
| Art. 22 – identification in the supply chain | NO (without prejudice to traceability requirements in the supply chain applicable to ‘IVD legacy devices’ in accordance with other rules such as on market surveillance of goods or the General Product Safety Directive) |
| Art. 24 – UDI | NO (See in this respect also MDCG 2019-5 on registration of legacy devices in Eudamed) |
| Art. 26 – registration of devices | In principle YES, but in the absence of EUDAMED’s full functionality, specific transitional provisions apply in accordance with Art. 112, 113(3)(f) IVDR |
| Art. 28 – registration of economic operators | In principle YES, but in the absence of EUDAMED’s full functionality, specific transitional provisions apply in accordance with Art. 112, 113(3)(f) IVDR |
| Art. 29 – summary of safety and performance | NO |
| Art. 78, 79 – PMS system and PMS plan | YES (including PMPF according to Annex XIII Part B; however with exception of requirements that relate to non-applicable obligations, e.g. Art. 78(3)(d) – Summary of safety and performance; no requirement for a full revision of the technical documentation in accordance with Annexes II and III) |
| Art. 80 – PMS report | YES, applicable to all ‘legacy devices’, unless manufacturer voluntarily prepares a PSUR pursuant to Article 81 |
| Art. 81 – PSUR | NO |
| Art. 82 – reporting of serious incidents | YES |
| Art. 83 – trend reporting | YES (trend reporting was already part of the vigilance system established under the IVDD) |
| Art. 84 – analysis of serious incidents and FSCA | YES |
| Art. 85 – analysis of vigilance data | YES |
| Art. 86 – implementing acts | YES |
| Art. 87 – EUDAMED vigilance module | In principle YES, but in the absence of EUDAMED’s full functionality, specific transitional provisions apply in accordance with Art. 112, 113(3)(f) IVDR |
| Art. 88 – market surveillance activities | YES |
| Art. 89 – evaluation of non-compliances | YES (nota bene: ‘conformity with the requirements of this Regulation’ for ‘legacy devices’ means conformity with the IVDD and the additional requirements in accordance with Article 110(3) IVDR) |
| Art. 90, 91, 92 – devices presenting an unacceptable risk; evaluation of national measures; other non-compliance | YES (nota bene: ‘conformity with the requirements of this Regulation’ for ‘legacy devices’ means conformity with the IVDD and the additional requirements in accordance with Article 110(3) IVDR) |
| Art. 93 – preventive health protection measures | YES |
| Art. 94 – good administrative practice | YES |
| Art. 95 – EUDAMED market surveillance module | YES |
