Medical Device “Certificates of Compliance” / “Attestation of Conformity” have no legal standing under MDR
Posts tagged as “MHrA”
First Do No Harm – The report of the Independent Medicines and Medical Devices Safety Review MHRA response statement to IMMDS Review report publication
Medicines and Medical Devices Bill: overarching documents
Guidance Notified bodies for medical devices
Clinical investigations of medical devices – guidance for manufacturers
MHRA guidance updated to reflect the MDR – Clinical investigations of medical devices – Biological safety assessment
Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2018 to 2019
MHRA launches consultation on how to best engage patients and the public
New information about upcoming MDR and IVDR regulations added to the page – Medical devices: guidance for manufacturers on vigilance
Recommendations from the independent Expert Advisory Group on the use of Paclitaxel Drug-Coated Balloons (DCBs) and Drug-Eluting Stents (DESs) to the MHRA