Today, 21 June 2023, the Official Journal of the European Union published the final text…
CE recognition period extended: UK law officially published
On 14 June 2023, the UK Government published The Medical Devices (Amendment) (Great Britain) Regulations…
MDR QMS compliance: Necessary elements by 2024
Manufacturers can benefit from the extended transitional period for legacy devices under certain conditions. One…
National implementation law: Turkey
The Turkish Medicines and Medical Devices Agency released its national legislation on medical devices in…
Updated MDCG Guidance on significant changes (MDR transitional provision)
On 12 May 2023, the Medical Device Coordination Group (MDCG) published the revised Guidance on…
Feedback on amendment of common specifications for products without intended medical purpose
Between 8 May and 5 June 2023, medical device stakeholders can submit feedback on the…
Guidance on content and structure of the clinical investigation report summary
According to Article 77 of the Medical Devices Regulation (MDR), the sponsor of a clinical…
Team-NB: Notified Body Confirmation Letter to prove application and signed agreement
The latest developments in the implementation of the medical devices and IVD medical devices Regulations…
UK: Extension of CE recognition & Registration of extended Certificates
The UK government announced that it intends to prolong the acceptance of CE marked medical…
MDR & IVDR national implementation: Malta
The Medicines Act 2020 “Medical Devices and In-Vitro diagnostic Medical Devices Provision on the Maltese…