by administrador | Apr 30, 2025 | Medical Devices
Article 10a – What Changes for Medical Device Manufacturers? As of 10 January 2025, a new obligation introduced by Regulation (EU) 2024/1860, under the MDR/IVDR requires manufacturers to notify relevant parties in advance when an interruption or discontinuation...
by administrador | Aug 2, 2024 | Medical Devices
Decree-Law No. 29/2024 and Medical Device Compliance in Portugal: Learn About the Main Changes New Decree-Law No. 29/2024 on Medical Devices On April 5, Decree-Law No. 29/2024 was published, ensuring the national implementation of Regulation (EU) 2017/745 concerning...
by Suporte | Feb 1, 2023 | Medical Devices
Breaking Down Notified Bodies’ Standard Fees: What You Need to Know The European Commission’s Medical Device Coordination Group (MDCG) has issued new guidance on the standard fees that Notified Bodies (NBs) must publish for conformity assessment and...
by Suporte | Feb 1, 2023 | Medical Devices
Extension of the EU MDR transition period – Recent Developments With EU Members arguing legislative measures had to be put forward to help prevent potential medical device shortages, the European Commissioner for Health and Safety proposed measures to extend the...
by Suporte | Feb 1, 2023 | Medical Devices
What you need to know – UDI in the MDR The new Medical Device Regulation 2017/745 (MDR) changed and introduced various requirements to obtain regulatory approval for medical devices in the EU. One of these is the introduction of the UDI – Unique Device Identifier, an...
