On 5 July 2023, the Official Journal of the European Union published two new harmonised…
CE recognition period extended: UK law officially published
On 14 June 2023, the UK Government published The Medical Devices (Amendment) (Great Britain) Regulations…
National implementation law: Turkey
The Turkish Medicines and Medical Devices Agency released its national legislation on medical devices in…
MDR & IVDR national implementation: Malta
The Medicines Act 2020 “Medical Devices and In-Vitro diagnostic Medical Devices Provision on the Maltese…
IMDRF latest developments: towards global regulatory harmonisation
International Medical Device Regulators Forum (IMDRF) is a group of regulators specialising in the field…
UK recognises extended CE Certificates
The UK is taking new steps to recognise the extended CE Certificates in light of…
Q&A on extension of the MDR transitional period and removal of the “sell off” period
Following the publication of the latest amendment to the Medical Devices Regulations (MDR and IVDR),…
Amendment to the MDR and IVDR transitional period is official!
Today, 20 March 2023, the Official Journal of the European Union published the latest amendment…
MDR & IVDR national implementation: Croatia
Croatian national laws implementing the Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostics…
New Timeline for MDCG Guidance Documents for 2023
The European Commission Directorate-General for Health and Food Safety has released the updated document on…