MDCG 2021-22 Rev. 1 : Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 – August 2021

7 Sep 2021 | All the News, MDCG

Theme Expert panel consultation referred to in article 48(6) of Regulation (EU) 2017/746 Target Audience Notified bodies – Manufacturers Products concerned IVD Documents mentioned IVDR (EU) 2017/746 Directive 98/79/EC   This MDCG guide sets out criteria to...

MDCG 2021-17 : Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/745 (MDR) – July 2021 MDCG 2021-18 : Applied-for scope of designation and notification of a conformity assessment body – Regulation (EU) 2017/746 (IVDR) – July 2021

7 Sep 2021 | All the News, MDCG

Theme Designation as notified bodies Target Audience Conformity assessment bodies Products concerned MD & IVD Documents mentioned MDR (EU) 2017/745 IVDR (EU) 2017/746 Commission implementing regulation (EU) 2017/2185   These MDCG guides (17 and 18) are the...