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…
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…
New Timeline for MDCG Guidance Documents for 2023
The European Commission Directorate-General for Health and Food Safety has released the updated document on the ongoing work of the MDCG and its subgroups. You…
Team-NB guidance on submission of technical documentation under IVDR
Team-NB has released a new position paper on the best practice guidance for submitting technical documentation under Annexes II and III of the IVDR. To develop…
IVDR: 10th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! National Standards Authority of Ireland (NSAI) is the 10th EU Notified Body notified under…
IVDR: 9th Notified Body on NANDO!
The NANDO database has a new Notified Body under the IVDR! MDC MEDICAL DEVICE CERTIFICATION GMBH is the 9th EU Notified Body notified under the…
Updated MDCG Guidance on classification rules for IVD medical devices
In February 2023, the Medical Device Coordination Group (MDCG) published a new revision of the Guidance on classification rules for IVD medical devices. The revision…