15 Jun 2023 | All the News
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...
15 Jun 2023 | All the News
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...
15 Jun 2023 | All the News
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...
15 Jun 2023 | All the News
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...
![Martina Cotena]()
12 May 2023 | All the News
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...
