Theme Clinical trials using diagnostic tests Target Audience Manufacturers and clinical trials sponsors Products concerned IVD & medicines Documents mentioned Regulation (EU) 2017/746 Regulation (EU) No 536/2014 Directive 98/79/EC This guide provides...
Theme Summary of safety and performance (SSP) Target Audience Manufacturer Products concerned Class C and D IVD Documents mentioned Regulation (EU) 2017/746 This guidance presents the model of the summary of safety and performance (SSP). This one must be established...
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...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
