UK – MHRA guidance on new Medical Devices Post-Market Surveillance requirements
A suite of guidance has been published by the Medicines and Healthcare products Regulatory Agency (MHRA). This guidance is designed to help medical device manufacturers...
UK – Implementation of medical devices future regime
The government intends to introduce new regulations for medical devices that prioritise patient safety, give patients access to the medical devices they need and...
USA – FDA finalizes guidance on reporting medical device shortages
The US Food and Drug Administration (FDA) issued finalized guidance on its requirements for notifying the agency of potential medical device shortages during or...
Europe – MDCG 2024-8 Rev. 1 Preliminary assessment review template – ...
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed...
Europe – MDCG 2024-7 Rev. 1 Preliminary assessment review template – MDR...
This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed...
Europe – MDR Certification Process (including Pre-application, Application and Post Application phases) – Consensus...
The purpose of this consensus document is to describe in detail the pre-application, application processes through which manufacturers may apply to Notified Bodies (NBs)...
Europe – MDCG 2023-3 Rev. 2 Questions and Answers on vigilance terms and concepts...
This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical...
USA – FDA issues much-anticipated guidance on pulse oximeters
The Food and Drug Administration on Monday released much-anticipated testing recommendations for pulse oximeters. The draft guidance follows years of discussion about concerns that the devices can be...
USA – FDA issues draft guidance on developing and managing AI-enabled devices
The US Food and Drug Administration (FDA) on Monday published a much-anticipated guidance on developing and managing medical devices with artificial intelligence (AI). The...
USA – FDA updates GUDID final guidance
The US Food and Drug Administration (FDA) issued an updated final guidance on Tuesday addressing the submission of unique device identifiers (UDIs) to the...
