Theme Vigilance Target Audience Manufacturers Products concerned Specific devices : cardiac ablation, coronary stents, cardiac implantable electronic devices, breast implants Documents mentioned MDR (EU) 2017/745 – articles 87 et 88, 92 IVDR (EU) 2017/746 –...
Theme Clinical investigation exemption, demonstrating equivalence Target Audience Manufacturers Products concerned Class III and implantable MD Documents mentioned MDR (EU) 2017/745 – Article 61(4)-(6) MDCG 2020-5 MDCG 2020-6 MDCG 2020-8 This MDCG guide aims...
Theme Clinical evaluation, demonstrating equivalence Target Audience Manufacturers, notified bodies Products concerned Products without an intended purpose listed in Annex XVI of MDR Documents mentioned MDR (EU) 2017/745 - Annex XIV, Annex XVI Implementing...
I worked as a physiotherapist for two years, after that I worked as a medical representative for a pharmaceutical laboratory. Then I decided to broad my skills and get a degree in Engineering and Ergonomics of Physical Activity before completing my academic career...
Theme Software Target Audience Manufacturers Products concerned MDSW (Medical device software) Regulatory reference MDR (EU) 2017/745 Documents mentioned MDCG 2019-11MDCG 2020-1MDCG 2019-16 This guidance examines and clarifies the specific regulatory aspects that...
After more than 20 years’ experience in medical devices and in vitro diagnostic medical devices fields, I joined nexialist team in November 2022. With an academic background in biomaterials, I had the opportunity to work in different environments : Research...
Theme Vigilance Target Audience Competent authorities, economic operators, and other interested parties Products concerned MD Regulatory reference MDR (EU) 2017/745 Documents mentioned MEDDEV 2.12/1 rev.8Regulation (EU) No 1025/2012EN ISO 15223-1:2021Manufacturer...
Theme List of standard fees Target Audience Notified bodies Products concerned MD, IVD Regulatory reference MDR (EU) 2017/745IVDR (EU) 2017/746 Documents mentioned MDCG 2019-6Recommendation 2003/361/EC Regulations (EU) 2017/745 and 2017/746 require Notified Bodies to...
Theme In house devices Target Audience Health institutions, healthcare professionals Products concerned MD, IVD Regulatory reference MDR (EU) 2017/745IVDR (EU) 2017/746 Documents mentioned MDCG 2020-16MDCG 2021-24 This MDCG document addresses so-called "in house"...
Theme PSUR – Article 86 MDR Target Audience Manufacturers of class IIa, IIb, and III medical devices Products concerned MD Regulatory reference MDR (EU) 2017/745 Documents mentioned MDCG 2022-14MDCG 2021-25MDCG 2021-3MDCG 2021-1 rev.1IMDRF Adverse Event Terminology...
