Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDRPDF · Unverified extraction previewOfficial source
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MDCG 2020-6Guidance on sufficient clinical evidence for legacy devicesBackground note on the relationship between MDCG 2020-6 and MEDDEV 2.7/1 rev.4 on clinical evaluationApril 2020⌄
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Gradual roll out of EUDAMEDQ&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices1November 2024⌄
Gradual roll out of EUDAMEDPDF · Unverified extraction previewOfficial source
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MDCG 2022-15Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDDSeptember 2022⌄
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MDCG 2022-8Regulation (EU) 2017/746 - application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/ECMay 2022⌄
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MDCG 2022-6Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDRMay 2022⌄
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MDCG 2021-4 rev.1Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746September 2024⌄
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MDCG 2020-3 rev.1Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDDNote to the reader: Due to technical issues, please disregard the document displayed from 7 September 2023 until 8 September 2023.September 2023⌄
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MDCG 2022-4 rev.2Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDDMay 2024⌄
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MDCG 2020-12Guidance on transitional provisions for consultations of authorities on devices incorporating a substance which may be considered a medicinal product and which has action ancillary to that of the device, as well as on devices manufactured using TSE susceptible animal tissuesJune 2020⌄
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Q&A rev.2Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periodsJuly 2024⌄
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MDCG 2022-18 ADD.1MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate - Addendum 1June 2023⌄
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MDCG 2022-18MDCG Position Paper on the application of Article 97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificateDecember 2022⌄
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MDCG 2021-25 rev.1Application 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/EECOctober 2024⌄
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