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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

10 Jun 2022 | All the News, MDCG, MDCG

Theme Transitional provisions Target Audience Manufacturers, Authorised representatives, Importers, Distributors, Notified Bodies Products concerned IVD Documents mentioned IVDR (EU) 2017/746 IVDR – Article 110 Blue Guide MDCG 2019-5 MDCG 2021-13 rev.1   This...

MDCG 2022-7 : MDCG 2022-7 – Questions and Answers on the Unique Device Identification system under Regulation (EU) 2017/745 and Regulation (EU) 2017/746

10 Jun 2022 | All the News, MDCG, MDCG

Theme UDI Target Audience Manufacturers, systems and procedure packs producers, kit producers   Products concerned MD, IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 UDI FAQ MDCG 2018-1 MDCG 2018-6 MDCG 2021-19 MDCG 2021-27 COMMISSION IMPLEMENTING...

MDCG 2022-6 : Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR

10 Jun 2022 | All the News, MDCG, MDCG

Theme Significant change under the transitional provisions Target Audience Manufacturer   Products concerned IVD : legacy devices Documents mentioned Regulation (EU) 2017/746 Directive 98/79/EC MDCG 2020-3 Regulation (EC) 1272/2008 Regulation (EC) No 1907/2006 Q&A...

MDCG 2022-5 : Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices

10 Jun 2022 | All the News, MDCG, MDCG

Theme Borderline between medical devices and medicinal products Target Audience Manufacturers Products concerned Borderline products Documents mentioned Directive 2001/83/EC Regulation (EU) 2017/746 Directive 93/42/EEC Regulation (EU) 528/2012 Directive 2004/27/EC...

MDCG 2022-4 Rev.2 : Guidance 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 AIMDD

1 Mar 2022 | MDCG, MDCG

Theme Surveillance of requirements for Legacy devices Target Audience Notified Bodies Products Concerned MD Documents mentioned MDR (UE) 2017/745 MDCG 2021-25 MDCG 2020-3 MDCG 2019-10 rev.1 MDCG 2021-1 rev. 1 NBOG BPG 2009-4   Legacy devices with valid EC...

MDCG 2022-3: Verification of manufactured class D IVDs by notified bodies

1 Mar 2022 | MDCG, MDCG

Theme Conformity assessment Target Audience Notified bodies Products Concerned Class D IVD Documents mentioned IVDR (EU) 2017/746 MDCG 2020-16 rev.1  The MDCG 2022-3 guidance specifies the role and responsibilities of Notified Bodies in the verification of batches or...
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