France – La HAS réévalue les systèmes connectés de prise en charge du diabète
Saisie par le ministère chargé de la Santé, la Haute Autorité de santé (HAS) a réévalué les conditions de prise en charge par l’Assurance...
UK – An update on our plans for Med Tech regulatory change
Our external engagement on the programme of regulatory changes for medical devices has re-started in earnest this week following the pre-election period and early...
Europe – Code of Conduct for Notified Bodies under Regulations (EU) 2017/745 and (EU)...
The work of Notified Bodies (“NBs”) in the Conformity Assessment and Certification of
Medical Devices (MD) and In-Vitro Diagnostic Devices (IVD) continues to be a...
Europe – MDCG 2021-4 rev.1 – Application of transitional provisions for certification of class...
According to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR), as part of conformity assessment of class D in vitro diagnostic...
USA – FDA names new head of medical device evaluation and quality
The Food and Drug Administration named Ross Segan as director of the medical device center’s Office of Product Evaluation and Quality (OPEQ), following a...
USA – FDA releases three post-pilot ASCA draft guidances
The US Food and Drug Administration (FDA) has issued its first set of draft guidance documents for the full-fledged Accreditation Scheme for Conformity Assessment...
International – The global regulatory landscape for AI/ML-enabled medical devices
Digital health has revolutionized the healthcare sector. Artificial intelligence (AI) and machine learning (ML) have gained widespread recognition because of their promising benefits in...
International – Artificial intelligence in medical devices
Welcome to the September issue of RF Quarterly, which includes articles examining artificial intelligence (AI) in medical devices, focusing on the global regulatory landscape, contact-free AI...
Europe – Notification of a Body in the framework of a technical harmonization directive
Body Name
ISTITUTO SUPERIORE DI SANITA'
Address
Viale Regina Elena, 299
00161 - ROMA
Country
Italy
Phone
+39 06 49906146
Fax
+39 06 49903150
Email
roberta.marcoaldi@iss.it
Website
www.iss.it
Body Number
0373
Last approval date
03/05/2016...
USA – FDA Authorizes First Over-the-Counter Hearing Aid Software
Today, the U.S. Food and Drug Administration authorized the first over-the-counter (OTC) hearing aid software device, Hearing Aid Feature, intended to be used with...
