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Medical Devices - Sector - Latest updates (143)
RSSMDR and IVDR Communication Survey
MDR and IVDR Communication Survey
Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period
Flowchart to assist in deciding whether or not a device is covered by the extended MDR transitional period
Rev. 1 - Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607
Rev. 1 - Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607
Add 1 - MDCG Position Paper on the application of Art.97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
Add 1 - MDCG Position Paper on the application of Art.97 MDR to legacy devices for which the MDD or AIMDD certificate expires before the issuance of a MDR certificate
New Commission Implementing Regulation (EU) 2023/1194 on transitional provisions for products without an intended medical purpose (Annex XVI)
New Commission Implementing Regulation (EU) 2023/1194 on transitional provisions for products without an intended medical purpose (Annex XVI)
UPDATE - MDCG 2020-3 Rev.1 - Guidance on significant changes regarding the transitional provision under Article 120 of the MDR - May 2023
UPDATE - MDCG 2020-3 Rev.1 - Guidance on significant changes regarding the transitional provision under Article 120 of the MDR - May 2023
2023/C 163/06 - Commission Guidance on the content and structure of the summary of the clinical investigation report - May 2023
2023/C 163/06 - Commission Guidance on the content and structure of the summary of the clinical investigation report - May 2023
Meeting audio available - Day 1 & 2: 27-28 March 2023 IMDRF Stakeholder Forum
Meeting audio available - Day 1 & 2: 27-28 March 2023 IMDRF Stakeholder Forum
IMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany
IMDRF Meeting 24th session - 25-26 September 2023 - Berlin, Germany
Q&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” periods
Q&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” periods
Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions
Regulation (EU) 2023/607 of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions
MDCG work in progress - Ongoing guidance documents
MDCG work in progress - Ongoing guidance documents
MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices - February 2023
MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices - February 2023
Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023
Update - MDCG 2020-16 Rev.2 - Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746 - February 2023
MDCG 2023-2 - List of Standard Fees - January 2023
MDCG 2023-2 - List of Standard Fees - January 2023
MDCG 2023-1 - Guidance on the health institution exception under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 - January 2023
MDCG 2023-1 - Guidance on the health institution exception under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 - January 2023
MDCG 2022-4 rev.1 - Guidance on appropriate surveillance regarding MDR Art.120 transitional provisions - devices covered by MDD or AIMDD certificates - December 2022
MDCG 2022-4 rev.1 - Guidance on appropriate surveillance regarding MDR Art.120 transitional provisions - devices covered by MDD or AIMDD certificates - December 2022
MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 - December 2022
MDCG 2022-21 - Guidance on Periodic Safety Update Report (PSUR) according to Regulation (EU) 2017/745 - December 2022
Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022
Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 - Version2 - December 2022
MDCG 2022-20 - Substantial modification of performance study under Regulation (EU) 2017/746 - December 2022
MDCG 2022-20 - Substantial modification of performance study under Regulation (EU) 2017/746 - December 2022