UPGRADE YOUR TRIALS FOR MDR BY MAY 26, 2021!
WHY WE MUST UPDATE OUR TRIALS If you sponsor a trial that is already ongoing, you must update your safety procedures in accordance with the MDR by the deadline of May 26, 2021. If you are just [...]
Austria: medical device and IVD clinical trials submission process changes during transition to MDR
The Austrian Federal Office for Safety in Health Care (BASG) gave information on a new validation process during the transition to the MDR which will come into force in May 2021.Meditrial manages several studies in Austria and has direct connections [...]
EU: MDCG issued a guidance on standardization for medical devices
The European Commission Medical Device Coordination Group (MDCG) adopted a new standardization request for harmonized European standards in support of the MDR and IVDR after its initial standardization request was rejected last year.Contact Meditrial for a free consultation regarding your device! [...]
Switzerland: New requirements and changes to authorization practice as of May 2021
Swissmedic has recently announced new regulations and requirements for the authorization of clinical trials in Switzerland. Meditrial and its team based in the Zug office manage several studies in Switzerland and has direct connections with Investigators, hospitals and local [...]
EU: MDCG issues Q&A on custom made devices
The European Commission Medical Device Coordination Group has issued a Q&A document on custom made devices. The document includes the definition of custom made device, examples of eligible and non-eligible devices and MDR-related procedures. Contact Meditrial to know how we [...]
EU: The European Commission issues a guidance on management of legacy devices in Eudamed
The European Commission issued a new guidance explaining how legacy devices and in vitro diagnostics (IVDs) will be managed in its Eudamed database, expected to be fully rolled out by May 2022. "Legacy Devices are defined as Medical Devices, Active [...]
Netherlands: Notifications of clinical investigations with medical devices to CCMO as of the 1st of October
From the 1st of October 2020, manufacturers of medical devices must register clinical investigations with the Dutch Central Committee on Research Involving Human Subjects (CCMO). The Committee will take over the tasks of the Healthcare and Youth Inspectorate (IGJ) [...]
EU: EUDAMED actor registration module active as of December 2020
With the MDR, EUDAMED will act as central repository of information to lay the foundation for collaboration, transparency and interaction of all parties, namely the new European databank for medical devices and in vitro diagnostic devices. EUDAMED will have several [...]
EU: Common specifications for reprocessing single-use devices set by the European Commission
On August 19th, 2020 the European Commission implemented regulation as regard common specifications for the reprocessing of single-use medical devices under the Medical Device Regulation (MDR). Under the MDR, single-use devices may be reprocessed where permitted by national law. Reach [...]
The European Commission updates on MDR implementation
The European Commission over the past week provided several updates on the implementation of the Medical Device Regulation (MDR) and released a fact sheet explaining the information that will be available to the public about devices according to transparency [...]
