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.
MEET us at MEDICA-COMPAMED 2023
Join SCC at MEDICA-COMPAMED in Dusseldorf on 13-16 November 2023
UK MDR: GB extends the acceptance of CE marked medical devices
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
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 […]
MDCG 2020-3 Rev.1: Guidance on significant changes to transitional provisions under Article 120 MDR revised
MDCG 2020-3 Rev. 1: Guidance on significant changes to transitional provisions under Article 120 MDR revised 31 May 2023 Medical devices placed on the market after the effective date of the Medical Device Regulation (EU) 2017/745 (MDR), 26 May 2021, and compliant with MDCG Guidance 2021-25 are considered “legacy devices“. These include: “devices which are […]
