USA – FDA updates third party 510(k) guidance
The US Food and Drug Administration (FDA) has published a draft guidance that updates a 2020 final guidance on its third party 510(k) review...
Europe – The clock is ticking – MedTech Europe’s recommendations ahead of May 2025...
Class D IVDs are critical for public health. They mainly fall into two categories: a) those related to blood, cells, tissues or organ screening,...
Europe – Questions & Answers for applicants, marketing authorisation holders of medicinal products and...
This Question and Answer (Q&A) document provides practical considerations concerning the implementation of the medical devices and the in vitro diagnostic medical devices regulations.
This...
Europe – MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products :...
The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR (medical device regulation), provides a possibility to use clinical data related...
Europe – MDCG 2023-5 – Guidance on qualification and classification of Annex XVI products...
The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR, is applicable to the groups of products without an intended medical...
Europe – Update – MDCG 2021-6 – Rev.1 – Regulation (EU) 2017/745 – Questions...
This document is intended for sponsors of clinical investigations of devices conducted within
the scope of the Regulation (EU) 2017/745 (MDR). This document may be...
USA – Experts discuss red flags that can trigger legal action against drug and...
Legal observers discussed some of the red flags that can trigger legal actions against healthcare product manufacturers, as well as some of the lessons...
Europe – Designation of EU reference laboratories for high-risk in vitro diagnostic medical devices
On 5 December 2023, the European Commission adopted an implementing act designating 5 EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices...
USA – Fall unified agenda includes new rule on removing outdated regulations, returning QMSR...
The Department of Health and Human Services (HHS) recently published the fall 2023 unified agenda for the US Food and Drug Administration (FDA) that...
USA – Combination products: FDA experts address UDI, harmonization, OPQ reorganization
Officials from the US Food and Drug Administration (FDA) fielded wide-ranging questions on the development and marketing of combination products — from UDI requirements...
