Standards, Guidance & Notices
Showing 21–30 of 37
JFMDA
Notice
Notice
jaame-committee
COVID-19 Prevention Guidelines for Medical Device Sales, Rental, and Repair Business Operations
JAAME Sales and Maintenance Committee published comprehensive COVID-19 prevention guidelines for medical device distribution and service sectors, updated May 8, 2023, addressing operational disruptions and infection control measures.
Published: 2023-03-15
EU
MDCG
MDCG
MDCG 2022-19
Performance study application/notification documents under Regulation (EU) 2017/746
MDCG 2022-19 — Performance study application/notification documents under Regulation (EU) 2017/746 — (December 2022)
Published: 2022-12-01
EU
MDCG
MDCG
MDCG 2020-10
Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form
MDCG 2020-10 — Guidance on safety reporting in clinical investigations Appendix: Clinical investigation summary safety report form — (October 2022 October 2022)
Published: 2022-10-01
EU
MDCG
MDCG
MDCG 2022-15
Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD
MDCG 2022-15 — Guidance on appropriate surveillance regarding the transitional provisions under Article 110 of the IVDR with regard to devices covered by certificates according to the IVDD — (September 2022)
Published: 2022-09-01
EU
MDCG
MDCG
MDCG 2022-12
Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices)
MDCG 2022-12 — Guidance on harmonised administrative practices and alternative technical solutions until Eudamed is fully functional (for Regulation (EU) 2017/746 on in vitro diagnostic medical devices) — (July 2022)
Published: 2022-07-01
EU
MDCG
MDCG
MDCG 2022-8
Regulation (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/EC
MDCG 2022-8 — Regulation (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/EC — (May 2022)
Published: 2022-05-01
EU
MDCG
MDCG
MDCG 2021-18
Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR)
MDCG 2021-18 — Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) — (July 2021)
Published: 2021-07-01
EU
MDCG
MDCG
MDCG 2021-17
Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR)
MDCG 2021-17 — Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) — (July 2021)
Published: 2021-07-01
EU
MDCG
MDCG
MDCG 2021-10
The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices
MDCG 2021-10 — The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices — (June 2021)
Published: 2021-06-01
EU
MDCG
MDCG
MDCG 2021-8
Clinical investigation application/notification documents
MDCG 2021-8 — Clinical investigation application/notification documents — (May 2021)
Published: 2021-05-01