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...
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MDCG 2021-27 Rev.1 : Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – December 2021
Theme Obligations of distributors and importers Target Audience Importers and distributors Products concerned MD & IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 MDCG 2018-6 MDCG 2021-13 MDCG 2021-23 MDCG 2021-26 Regulation (EU) 2019/1020 : market...
MDCG 2021-28: Substantial modification of clinical investigation under Medical Device Regulation – December 2021
Theme Notification of a substantial modification of clinical investigation Target Audience Sponsor of a clinical investigation Products concerned MD Documents mentioned MDR (EU) 2017/745 MDCG 2021-8 MDCG 2021-20 The sponsor of a clinical investigation is required to...
New harmonised standards under the MD and IVD Regulations: all you need to know about presumption of conformity
New lists of harmonised European standards under the Medical Devices (MD) and IVD Regulations have been published in the Official Journal of the European Union. There are now 14 standards harmonised under the MD Regulation and 9 standards harmonised under the IVD...
New Implementing Regulation on electronic instructions for use : under what conditions can we dispense with the paper format ? What changes have been made?
The European Commission published on December 14 in the Official Journal of the EU the Implementing Regulation (EU) 2021/2226 laying down detailed rules for the application of Regulation (EU) 2017/745 as regards electronic instructions for use for medical devices...
MDCG 2021-26 : Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – October 2021
Theme Obligations of persons referred to in Article 16 Target Audience Importers and distributors Products concerned MD & IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 This guide presents a series of questions and answers about the obligations of...
MDCG 2021-25 Rev 1 : Regulation (EU) 2017/745 – application 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/EEC – Octobre 2021
Theme Interpretation of the transitional provisions for DM certified under the Directives Target Audience Manufacturers, Notified Bodies Products concerned MD certified under the directives (IVD excluded) Documents mentioned MDR (EU) 2017/745 MDR – Article 120 Blue...
In vitro diagnostic medical devices: European Commission proposes to extend the duration of the transitional provisions
In order to ensure a continuous supply of in vitro diagnostic medical devices, the European Commission proposes to extend the periods initially foreseen in the Regulation concerning the transitional provisions. Please note that this proposal does not aim to change the...
MDCG 2021-24 : Guidance on classification of medical devices – October 2021
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 2021-23 : Guidance for notified bodies, distributors and importers on certification activities in accordance with Article (16)4 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – August 2021
Theme Certificates Target Audience Notified bodies, distributors and importers Products concerned MD & IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 This guide is intended to assist NB in carrying out certification activities in accordance...
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