medicines-medical devices-regulatory affairs
On 6 January 2023, the European Commission adopted a proposal allowing more time to certify medical devices to mitigate the risk of shortages. The proposal: Further details are provided below. What does the length of the proposed extension period depend…
Guidance No About the guidance MDCG 2022-4 rev.1 Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD, Revision 1 – December…
Guidance No About the guidance MDCG 2021-22 Rev.1 Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6)…
The UK government has responded to the medical devices consultation (the original consultation is half way down the page) held between September and November 2021, with new plans to strengthen the regulation of medical devices in the UK. Following the…
The Medical Device Coordination Group (MDCG) has published the following updates: Guidance No About the guidance MDCG 2022-11 MDCG Position Paper: Notice to manufacturers to ensure timelycompliance with MDR requirements From 27 May 2024, the MDR will be fully applicable…
The following commission implementing decisions on the harmonised standards for medical devices drafted in support of the Medical Devices Regulation (EU) 2017/745 (MDR) of the European Parliament and of the Council have been published thus far: Commission Implementing Decision (EU)…
Hologic has launched its Artificial Intelligence (AI) based Genius Digital Diagnostics system in Europe, for cervical cancer screening. The burden of cervical cancer in Europe According to a study by the EPF in 2020: Current estimates indicate that every year, 61,072…
The Medical Device Coordination Group (MDCG) has published the following updates: MDCG number Notes MDCG 2021-26 Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746This document presents questions and answers…
TGA, Australia has published guidance on the imminent reclassification of certain medical devices. Which medical devices are going to be reclassified? The following medical devices are going to be reclassified: Medical devices in direct contact with the heart, central circulatory…
The UK MHRA is updating regulations applying to software and artificial intelligence (AI) as a medical device. The exciting and fast developing field of software and artificial intelligence (AI) as a medical device has an increasingly prominent role within health…