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...
After more than 20 years in medical device industry (manufacturing, quality and regulatory), I have started my new nexialist challenge in February 2022 as Quality Consultant with one main focus “THE PATIENT”, thus product safety. I worked for medical device supplier...
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 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...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
