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 […]
Team-NB publishes best practice guidance for the submission of technical documentation for IVD MD
Team-NB publishes best practice guidance for the submission of technical documentation for IVD MD 3 May 2023 In February 2023, the European Association of Medical devices Notified Bodies, or Team NB, published the position paper „Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Devices […]
Team-NB revises the best practice guidance for the submission of technical documentation for medical devices
Team-NB revises the best practice guidance for the submission of technical documentation for medical devices 2 May 2023 On 19th April 2023, the European Association of Medical devices Notified Bodies, or Team-NB, published Version 2 of the position paper “Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of Medical […]
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European Commission extends MDR transition period
On 7 March 2023, the EU Council adopted the Commission’s proposal granting notified bodies and manufacturers more time to certify medical devices.
MDCG guidance on classification rules for IVDs revised
MDCG updates the guidance on classification rules for in vitro diagnostic medical devices
New MDCG guidance – questions and answers on vigilance terms and concepts according to MDR available
New MDCG guidance on vigilance terms and concepts according to MDR available since February 13, 2023
MDCG guidance on application of MDR Article 5(5) to in-house medical devices published
MDCG issues the guidance on application of MDR Article 5(5) setting rules for the manufacture and use of in-house medical devices
Commission implementing regulation (EU) 2022/2346 and 2022/2347 regarding MDR published
Regulation (EU) 2022/2346 lays down common specifications for all groups of products in Annex XVI of the MDR without an intended medical purpose.
EU commission adopted proposal for a longer transition period to adapt to MDR
The transition period is extended until 31 December 2027 for higher risk devices, until 31 December 2028 for medium & lower risk devices and until 26 May 2026 for class III implantable custom-made devices.
