Europe – MDCG 2023-1 Guidance on the health institution exemption under Article 5(5) of...
Medical devices can be manufactured and used within EU health institutions (in-house
devices), on a non-industrial scale, to address the specific needs of target patient...
Europe – MDR transition delay needs clarification, industry engagement to succeed
Whether the new proposal from the European Commission to delay the EU Medical Device Regulation (MDR) transition period works out will depend on the...
UK – Artificial pancreas technology set to change lives
Individuals who are typically unable to manage their type 1 diabetes will be offered new technology to help them control their condition. Furthermore, the...
Europe – Santé publique: plus de temps pour certifier les dispositifs médicaux afin de...
La Commission a adopté aujourd'hui une proposition visant à accorder plus de temps certifier les dispositifs médicaux afin de limiter le risque de pénuries. La...
UK – Exceptional use of non-UKCA marked medical devices
A manufacturer can apply to supply a medical device that does not comply with the law to protect a patient’s health if there is...
Europe – The designation of notified bodies under the upcoming Artificial Intelligence Act
Artificial Intelligence (AI) algorithms, in its various forms, machine learning, deep learning, etc., implemented as embedded software (SW) or standalone SW, are gaining in...
UK – Medical devices: UK approved bodies
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002)...
Europe – European Commission Proposes Extending MDR, IVDR Transition Periods
At the EPSCO Health Council on 14 June 2022, Health Ministers expressed their concerns that severe challenges related to the implementation of Regulation (EU)...
Switzerland – Swiss Regulators Set To Recognize US FDA-Cleared or Approved Medical Devices
Swiss legislators have authorized adoption of new laws to recognize medical devices and in vitro diagnostic (IVD) devices that have received US Food and...
Europe – Manual on borderline and classification for medical devices under Regulation (EU) 2017/745...
Determining whether a given product falls under the definition of a medical device and the
application of the classification rules fall within the competence of...
