The two co-legislators of the European Union: the European Parliament and the Council of the EU have commonly agreed to delay the date of application of IVDs requiring Notified Body involvement under the In Vitro Devices Regulation 2017/746 (IVDR). With the aim of maintaining the supply of these medical devices, this postponement of the requirements varies in time depending on the class of In Vitro Device:
- Class D requirement will apply from May 2025;
- Class C from May 2026;
- Class B and A (sterile) from May 2027;
Additionally, ¨in house¨ devices requirements are delayed until May 2024 or May 2028 if the health institution proves the unavailability of an equivalent device on the market. Thus, this extension of deadlines follows what was previously explained in another MDlaw post addressing the proposal from the European Commission. Finally, the following devices:
- CE-marked devices that do not require notified body involvement; and
- “new” devices that have neither a notified body certificate nor a declaration of conformity under IVDD 98/79/EC
are not subject to the aforementioned provisions. Therefore, for them the IVDR 2017/746 is applicable from 26 May 2022. This roll-out will soon be published in the Official Journal of the European Union, thus coming into force.
All documents are available in our dedicated IVDR Library of documents!
REFERENCES
https://ec.europa.eu/commission/presscorner/detail/en/ip_21_6965
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A02017R0746-20170505
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:01998L0079-20120111&from=EN
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