MDG 2024 – MedGenerAction Health Matters: Highlights
This white paper brings together some of the key information presented and discussed in the morning session of the MDG [...]
13 12 2024
13 12 2024
04 12 2024
04 12 2024
Practical Guide to the Classification of Medical Devices in the U.S.
This White Paper is a concise and practical guide to the classification of Medical Devices in the United States, with a [...]
22 11 2024
22 11 2024
Shortages of Medical Devices: Questions and Answers on Article 10a of Regulation (EU) 2024/1860
22/11/2024 The European Commission has recently published a document entitled 'Q&A Obligation to inform in case of interruption or discontinuation of [...]
22 11 2024
22 11 2024
Innovative Medical Devices in Saudi Arabia: Updated SFDA MDS – G002 Guidance. Version 3.0 (2024)
22/11/2024 In the wake of the increasing technological development in the medical device sector, the Saudi Food and Drug Authority (SFDA) [...]
22 11 2024
22 11 2024
MDCG Guideline 2022-5 Rev.1 Update: Clarification of Borderline Products between Medical Devices and Medicinal Products
22/11/2024 In October 2024, the Medical Device Coordination Group (MDCG) published the updated version of MDCG Guideline 2022-5 Rev. 1, entitled [...]
19 11 2024
19 11 2024
Trend Analysis in Post-Market Surveillance (PMS)
The European Union's MDR (EU) 2017/745 requires medical device manufacturers to adopt a systematic Post-Market Surveillance (PMS) process to ensure the [...]
18 10 2024
18 10 2024
Published MDCG Guidance 2024-11 for IVD Qualification
18/10/2024 On October 8, 2024, the Medical Device Coordination Group (MDCG) of the European Commission published the MDCG 2024-11 - Guidance [...]
18 10 2024
18 10 2024
ASCA Programme Updates: Three Draft FDA Guidelines
18/10/2024 On September 15, 2024, the FDA updated three draft guidelines related to ASCA (Basic Safety and Essential Performance), a voluntary [...]
18 10 2024
18 10 2024
CDRH Expands Voluntary Pilot Tap (Total Product Life Cycle Advisory Programme)
18/10/2024 On October 1, 2024, the FDA's Centre for Devices and Radiological Health (CDRH) in the US announced that devices with [...]
15 10 2024
15 10 2024
Medical Devices Change Management in the European Union and MDSAP Countries
Change management in Medical Devices is essential to ensure European and international compliance. After the product is first placed on the [...]
