Great Britain Medical Device Registration
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA), under the jurisdiction of the UK Department of Health and…
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New Guidance on EtO in Medical Device Sterilization
The Medical Device Coordination Group (MDCG) has released a new guidance document, MDCG 2024-13,…
Defining Medical Device vs Medicinal Product | MDCG 2022-5
The Medical Device Coordination Group (MDCG) has released a revision of the MDCG 2022-5 guidance, which…
New EU Guide | Medical Device Supply Interruption
The European Commission has released a comprehensive Q&A guide to clarify new reporting obligations regarding the supply interruption…
EU Parliament Urges Revision of MDR and IVDR
The European Parliament has published the adopted text of a resolution entitled ‘Urgent need to revise the medical…
Australia Accepts US FDA 510(k) for Class III & IIa Devices
On 16 October, an amendment to Australian legislation was published that expands the conditions for medical devices already marketed in…
FDA Issues Draft Guidance on Chemical Analysis for Devices
The FDA issued draft guidance on September 19, 2024, concerning its recommendations related to chemical analysis for biocompatibility assessment of…
FDA Recognizes New Sterility Standards for Medical Devices
Currently the FDA recognizes 100’s of consensus standards from reputable organizations such as ISO, ANSI, AAMI, IEC, ASTM, etc. These…
FDA Final Rule Changes for Medical Devices and LDTs
The final rule related to medical devices and LDTs (Laboratory Developed Tests) was finalized in April 2024 by the FDA.
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