UK – Register medical devices to place on the market
All medical devices, including IVDs, custom-made devices and systems or procedure packs, must be registered with the MHRA before they can be placed on the market in...
Europe – Accord avec le Royaume-Uni relatif à la reconnaissance mutuelle en matière d’évaluation...
Depuis le retrait du Royaume-Uni de l’UE, l’accord entre la Suisse et l’UE relatif à la reconnaissance mutuelle en matière d’évaluation de la conformité...
Europe – Lancement d’un groupe de travail européen sur l’évaluation des DM numériques (ANS)
PARIS (TICpharma) - Un groupe de travail européen sur l'évaluation des dispositifs médicaux (DM) numériques a débuté ses travaux en vue de "parvenir à...
Europe – European Notified Body survey: MDR, IVDR certification numbers remain low
A new survey from the European Commission shows that many medical device and in vitro diagnostic (IVD) manufacturers have yet to apply for certification...
Europe – Notified bodies survey on certifications and applications
Notified Bodies Survey on certifications and applications (MDR/IVDR) - MDCG & Stakeholders...
UK – New device launched for diagnosing prostate cancer
CamPROBE may save vital time and money while reducing the risk of infection
November will witness the launch of a new device that is set...
Europe – MDCG 2022-16 – Guidance on Authorised Representatives Regulation (EU) 2017/745 on medical...
Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if...
UK – MHRA : Implementation of the Future Regulations
The future Medical Device Regulations is a substantial reform of the current framework as outlined in the government response. The government is committed to...
UK – Implementation of the future regulation of medical devices and extension of standstill...
On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom....
Europe – COMMISSION IMPLEMENTING REGULATION (EU) …/… laying down common specifications for the groups...
This Regulation lays down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745.
Annex...
