Team-NB: Position paper on medical device lifetime
Team-NB published a position paper on the lifetime of medical devices on 15 December 2023
Commission Implementing Regulation 2023/2713 published
2023/27 designating EU reference laboratories in the field of IVD MD
MDCG 2022-11 revised in November 2023
Notice to manufacturers to ensure timely compliance with MDR requirements
SCC team at MEDICA-COMPAMED 2023
Thank you for joining us at MEDICA-COMPAMED 2023
MDCG 2023-4 Guidance for Medical Device Software (MDSW) – Hardware combinations published
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 […]
US-FDA publishes a revised guidance “Use of International Standard ISO 10993-1”
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.
Team NB publishes position paper on transfer agreement for surveillance of legacy devices
On 14 August, Team-NB published the position paper on transfer agreement for surveillance of legacy devices.
EU Commission Issues an Addendum to MDCG 2022-18 Position Paper on Application of Article 97
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 […]
Implementing Regulation (EU) 2023/1194 on transitional provisions for Annex XVI products adopted
In June 2023, EC adopted the Implementing Regulation (EU) 2023/1194 on transitional provisions for certain products without an intended medical purpose.
