Europe – MDCG 2024-12 Corrective and preventive action (CAPA) plan assessment: guidance and templates...
This guidance document is intended for conformity assessment bodies (CABs), notified
bodies (NBs), designating authorities (DAs), and Joint Assessment Teams (JATs) involved
in Regulation (EU) 2017/745...
UK – MHRA e-cigarette and vape products regulator profile
The information below contains the contact details and responsibilities of each of the regulatory bodies involved in the regulation of e-cigarette and vape products...
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...
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...
Europe – EU Update: Current State of Medical Device Regulations
Amending legislation published to extend the transition of legacy IVDs and roll out EUDAMED
Regulation 2024/1860 was officially released to extend the transition time for legacy...
Europe – New pilot programme to support orphan medical devices
EMA has launched a pilot programme for expert panels to support the development and assessment of orphan medical devices in the European Union (EU)....
Europe – Commission Implementing Decision (EU) 2024/2120 of 30 July 2024 renewing...
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) 2017/745 of the European Parliament and of...
Europe – Medical device competent authority statement on the status of the EU regulatory...
National Competent Authorities have endorsed a consensus statement and shared it with the European Commission on the status of the EU regulatory framework for...
