NEWS
Medical Devices – Latest News
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...
Read MoreUS-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...
Read MoreTeam 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...
Read MoreEU 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...
Read MoreImplementing 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...
Read MoreSubscribe to our News
Stay up to date on regulatory issues relating to the approval and marketing of medical devices