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