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...
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...
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...
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 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...
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...
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...
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 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...
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...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
