Europe – Team-NB asks for regulatory clarity and for manufacturers to not delay MDR...
Notified bodies (NB) say that while extending the deadline to transition to EU Medical Device Regulation (MDR) has been a positive move, there is...
Europe – New European Manual on Borderline and Classification for medical devices and IVDs...
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...
Europe – MDCG 2024-5 guidance on content of the Investigator’s Brochure for clinical investigations...
When a sponsor of a clinical investigation shall submit an application according to article 70(1) of the MDR, the application shall be accompanied by...
USA – FDA opens TAP
The US Food and Drug Administration (FDA) has initiated a soft launch of its Total Product Lifecycle Advisory Program (TAP), which was negotiated under...
Europe – Update – MDCG 2022-13 Rev.1 – Designation, re-assessment and notification of conformity...
This document aims to provide guidance to the authorities responsible for notified
bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs)
when conducting:
− assessments of...
France – Surveillance des infections associées aux dispositifs invasifs en 2020
Santé publique France publie les résultats de la 2e édition de la mission nationale SPIADI menée entre le 1er janvier et le 15 juillet...
Europe – MedTech Europe’s vision for a resilient medical technology ecosystem
The digital ecosystem has dramatically changed the way in which healthcare is delivered to patients. Nowadays, medical technology companies concentrate not only on ensuring...
USA – FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They...
Physicians heavily rely on laboratory tests to make critical decisions about their patients’ care—roughly 70% of healthcare decisions depend on laboratory test results according...
Europe – MDCG 2022-14 – Transition to the MDR and IVDR – Notified body...
The MDCG recognises that significant and urgent challenges remain in ensuring sufficient
capacity of notified bodies and readiness of manufacturers in order to allow medical...
Europe – Annual report 2023
The Management Board’s oversight role covers the full range of EMA programmes and activities, making sure that the Agency works effectively and co-operates successfully...
