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MDCG 2023-4 guidance was published on 18 October 2023
New ISO 10993-17:2023 available defining the toxicological risk assessment of medical device constituents
New ISO 10993-17:2023 available defining the toxicological risk assessment of medical device constituents 22 September 2023 The new ISO 10991-17:2023 (Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents) has been published. After more than 20 years, the standard replaces the previous version from 2002, introducing a lot of […]
On September 8, the FDA published an update of the document “Use of International Standard ISO 10993-1”, adapting it to the newest ISO 10993-1:2018.
On 14 August, Team-NB published the position paper on transfer agreement for surveillance of legacy devices.
Team NB publishes position paper on transfer agreement for surveillance of legacy devices 18 August 2023 On 14 August, Team-NB published the position paper on transfer agreement for surveillance of legacy devices. The agreement template specifies the terms of transfer of appropriate surveillance activities in respect of legacy devices certified in accordance with Directive 90/385/EEC […]
In June 2023, EC adopted the Implementing Regulation (EU) 2023/1194 on transitional provisions for certain products without an intended medical purpose.
Join SCC at MEDICA-COMPAMED in Dusseldorf on 13-16 November 2023
MHRA announces the deadline extension for the acceptance of CE marked medical devices and IVDs shortly before the expiry of the transitional period.
Notified Body Confirmation Letter – EU 2023/607 6 June 2023 The European Commissioners have issued a new confirmation letter on the recent amendments to the Medical Device Regulation (MDR + IVDR). The eagerly awaited publication of the Template for NB – Confirmation letter in the framework of Regulation (EU) 2023/607 has now been officially communicated […]