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...
Expert biologist in the field of health. Holder of a Marie-Curie H2020 research doctorate in Health and Development Biology. This interdisciplinary project focused on identifying the effects of nanomaterials and organic pollutants on the reproductive toxicity of...
Area Publication or last update date Text Theme Scope nexialist synthesis EU 2016 Regulation (EU) 2016/679 on General Data Protective Regulation Data management Artificial intelligence Link EU 2018 European Commission : Questions and Answers: coordinated plan...
Government of the Netherlands: Legal analysis – European legislative proposal draft AI act and MDR/IVDRGovernment of the Netherlands: Legal analysis – European legislative proposal draft AI act and MDR/IVDRThis legal analysis carried out by Hooghiemstra & Partners...
WHO Ethics and Governance of AI SystemsWHO Ethics and Governance of AI SystemsThe World Health Organization released a general report in 2021 on the use of artificial intelligence in health and the challenges and risks that these technologies can produce. In this...
