The US Food and Drug Administration (FDA) has published an updated version of the guidance on the use of ISO 10993-1 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) to support medical devices application. Read more “New version of the FDA guidance on the use of ISO 10993-1”
Category: Medical device
Keep up to date with the latest medical device news in the pharmaceutical industry.
New guidelines on the submission of periodic risk assessment reports to the NMPA
Medical device manufacturers seeking to market their products in China will be required to adhere to new guidelines in the risk assessments they submit to the National Medical Products Administration (NMPA). Read more “New guidelines on the submission of periodic risk assessment reports to the NMPA”
Post-transition guidance from the MHRA: Medical Devices
On 01 September 2020, the Medicines and Healthcare products Regulatory Agency (MHRA) laid out the future UK requirements on device certification, conformity marking and registration with the agency. Read more “Post-transition guidance from the MHRA: Medical Devices”
FDA finalises two device-specific guidances
The device-specific guidances establish performance criteria to support 510(k) clearance via the new safety and performance based pathways. Read more “FDA finalises two device-specific guidances”
Switzerland approves revision of the Medical Devices Ordinance (MedDO)
In a move towards harmonisation with the EU Medical Device Regulation (MDR), the Swiss Federal Council have approved a thorough revision of MedDO and the new Ordinance on clinical Trials for Medical Devices (ClinO-MD). Read more “Switzerland approves revision of the Medical Devices Ordinance (MedDO)”
Find out about the latest MDR implementation updates
The European Commission (EC) have recently provided several updates on the implementation of the Medical Device Regulation (MDR). Read more “Find out about the latest MDR implementation updates”
FDA e-submissions for medical devices
A new guidance finalised by the US Food and Drug Administration (FDA) outlines the framework for electronic submissions for medical devices. Read more “FDA e-submissions for medical devices”
Exceptional use authorisations for medical devices during COVID-19
The Medicine and Healthcare Products Regulatory Agency (MHRA) have released a list of medical devices granted exceptional use applications during the pandemic. Read more “Exceptional use authorisations for medical devices during COVID-19”
Transitioning devices with ancillary substances to MDR
A guidance recently published by the Medical Device Coordination Group (MDCG) explains the process for transitioning CE certificates for devices containing an ancillary substance under the Medical Device Regulation (MDR). Read more “Transitioning devices with ancillary substances to MDR”
The latest update on the MDR, IVDR implementation timeline
The European Commission (EC) has updated its rolling plan for adopting implementing acts ahead of the Medical Device Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). Read more “The latest update on the MDR, IVDR implementation timeline”