![Less than 16 months before IVDR date of application, have you gotten a head start ? It’s time to get moving !]()
20 Jan 2021 | Regulation
The new in vitro Diagnostic Regulation (EU) 2017/746 (IVDR) which replaces the IVD Directive (98/79/EC), entered into force on May 25th 2017, and will enter into legal application by 26 May 2022 after a 5-yeartransition period. Team-NB published a consideration...
14 Jan 2021 | Regulation
Given the exceptional circumstances of the COVID-19 epidemic, the European Commission published a Notice on 11/01/2021 that temporarily allows notified bodies to perform remote conformity assessments of manufacturers QMS under the MDR/IVDR. Certain conditions...
24 Dec 2020 | MDCG
Theme COVID-19 – Audit Target Audience Notified Bodies, Manufacturers, Subcontractors Products concerned MD, IVD Documents mentioned MDCG 2020-4 : Guidance on temporary extraordinary measures related to medical device notified body audits during COVID-19...
24 Dec 2020 | MDCG
Theme UDI – EUDAMED Target Audience Manufacturers Products concerned Spectacle lenses and ready readers Documents mentioned MDR (EU) 2017/745 Article 10(7) Chapter III : Article 27, Article 27(3), Article 29, Article 31 Annex VI In this document, the...
24 Nov 2020 | MDCG
Theme Classification Target audience Manufacturers, Notified Bodies (NB) Products concerned IVD Regulatory references IVDR (EU) 2017/746 Annex VIII This MDCG document is a real mine of information for interpreting the classification rules of the IVD...
