The European Commission has officially announced a delay in the full implementation of the EUDAMED database. As mentioned in a previous post, this delay will…
Classification of medical devices: Which legal provisions and guides to consider?
A key moment in the compliance process of products is their classification. It is the manufacturer’s sole responsibility to select the appropriate class and rule…
IVDR: 11th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! Eurofins Electric & Electronics Finland Oy is the 11th EU Notified Body notified under…
Poland: MDR & IVDR national implementing laws
Upon the publication of the Medical Devices Regulation 2017/745 (MDR) and the In Vitro Diagnostic Devices Regulation 2017/746 (IVDR), Poland has taken steps to establish…
Legacy device manufacturers: Important deadlines & steps
Legacy devices are devices that are typically covered by a valid CE Certificate or are being up-classified by the Regulations and benefit from a special…
European Commission updates factsheet for non-EU/EEA authorities
The European Commission has published an updated factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices. This factsheet seeks…
CE recognition period extended: UK law officially published
On 14 June 2023, the UK Government published The Medical Devices (Amendment) (Great Britain) Regulations 2023. As mentioned in our previous post, Statutory Instrument 2023…
National implementation law: Turkey
The Turkish Medicines and Medical Devices Agency released its national legislation on medical devices in June 2021. In this sense, as per the Customs Union between…
MDR & IVDR national implementation: Malta
The Medicines Act 2020 “Medical Devices and In-Vitro diagnostic Medical Devices Provision on the Maltese Market Regulations” implements the EU Regulations on medical devices and…
MDR & IVDR national implementation: Croatia
Croatian national laws implementing the Medical Devices Regulation (MDR) 2017/745 and the In Vitro Diagnostics Devices Regulation (IVDR) 2017/746 are mainly the Act on the…