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MDCG 2022-2: Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) – January 2022

7 Feb 2022 | MDCG, MDCG

Theme Clinical evidence – Performance evaluation Target Audience Manufacturers, investigators and study sponsors, regulators, notified bodies and other stakeholders when considering clinical evidence Products concerned IVD Documents mentioned IVDR (EU) 2017/746...

MDCG 2022-1: Notice to third country manufacturers of SARS-CoV-2 in vitro diagnostic medical devices – January 2022

7 Feb 2022 | MDCG, MDCG

Theme Compliance of SARS-CoV-2 IVDs with the requirements of Directive 98/79/EC or Regulation (EU) 2017/746. Target Audience Manufacturers of IVDs for the detection/quantification of markers of SARS-CoV-2 infection established outside the EU or EEA and intending to...

MDCG 2021-24 : Guidance on classification of medical devices – October 2021

11 Oct 2021 | All the News, MDCG, MDCG

Theme Classification Target Audience Manufacturers, Notified Bodies (NB) Products concerned MD Documents mentioned MDR (EU) 2017/745 Annex VIII This MDCG document is a real mine of information for interpreting the classification rules of the MD Regulation, which until...

MDCG 2021- 10 – The status of appendixes E-I of IMDRF N48 under the EU regulatory framework for medical device – May 2021

9 Jul 2021 | All the News, MDCG, MDCG

Theme UDI Target Audience Manufacturer   Products concerned MD and IVD Documents mentioned MDR (EU) 2017/745 Annex VI IVDR (EU) 2017/746 IMDRF/UDI WG/N48 FINAL: 2019 MDCG 2019-11   This document is intended to provide interpretations on how certain principles and...
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