Swissmedic have announced that the first two modules (actor and device) of the Swiss national regulators database 'Swissdamed’ have gone live.
Ben KempAugust 14, 2024
CLSI have updated EP30 – Characterization and Qualification of Commutable Reference Materials for Laboratory Medicine, 2nd Edition. Updated to align with the current ISO 17511:2020 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples and current versions of CLSI EP14 Evaluation of Commutability of Processed Samples, 4th…
Ben KempAugust 14, 2024
You can find EFLM's newsletter here, including updates from EFLM’s green labs, and updated urinalysis recommendations.
Ben KempAugust 7, 2024
On 9 July 2024, WHO announced the launch of the first global open-access platform for medical devices: MeDevIS. MeDevIS references two international naming systems for medical devices - the European Medical Device Nomenclature (EMDN), mostly used in European countries for registration in the European database, and the Global Medical Device Nomenclature (GMDN) used in regulatory agencies in Australia, Canada, the…
Ben KempJuly 16, 2024
New laws and regulations at the state and federal levels in the U.S. are anticipated to create mandatory requirements for thousands of companies to provide climate-related reporting, in areas including value chain emissions and climate-related risks, even in the potential absence of climate reporting rules from the Securities and Exchange Commission (SEC), according to a new report by Fitch Group’s…
Ben KempJuly 16, 2024
Please note this is an extract of the original bulletin. Go-live for the swissdamed Actors module Since 26 May 2021, Swiss economic operators (manufacturers, importers and authorised representatives) have had to register with Swissmedic in order to obtain a unique registration number (Swiss Single Registration Number – CHRN). The Actors module of swissdamed will be available from 6 August 2024. After…
adminJuly 3, 2024
The National Institute of Standards and Technology (NIST) is an agency of the US Department of Commerce whose mission is to promote innovation in America. The agency has updated the widely used Cybersecurity Framework (CSF), its landmark guidance document for reducing cybersecurity risk. The new 2.0 edition is designed for all audiences, industry sectors and organization types, from the smallest…
adminMarch 6, 2024
This guidance document has been updated to expand on the definition of "significant change" in the Medical Devices Regulations (regulations). This will help you determine whether a change proposed to a Class III or IV medical device is significant. Health Canada have a updated the Guidance on how to interpret ‘significant change’ of a medical device in order to expand…
adminFebruary 14, 2024
Please note this is an extract of the original bulletin. swissdamed – Swiss Database on Medical Devices The “going-live” date being deferred to the 2nd half of 2024
adminFebruary 14, 2024