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