The European Commission (EC) has released documents outlining the principles behind EUDAMED’s nomenclature. Read more “The principles behind the European Medical Device Nomenclature to support EUDAMED”
Category: Medical device
Find out about the eCopy Program for medical device submissions to the FDA
Did you know that section 745A (b) of the Federal Food, Drug, and Cosmetic (FD&C) Act requires submission of electronic copies (eCopy) for medical device submissions? Read more “Find out about the eCopy Program for medical device submissions to the FDA”
Regulis wins TOPRA Regulatory Support Award 2019!
We are thrilled to announce that our medical devices team collected the Support award at TOPRA’s 10th Awards for Regulatory Excellence. Read more “Regulis wins TOPRA Regulatory Support Award 2019!”
How will Canada’s new Medical Devices Directorate help to tackle the growing medical device industry?
Health Canada recently announced the creation of a new Medical Devices Directorate (MDD), to address the challenges and opportunities relating to the ever-changing landscape of the medical device industry. Read more “How will Canada’s new Medical Devices Directorate help to tackle the growing medical device industry?”
MDCG issues guidance on legacy device certification issues surrounding the new MDR
There has been growing concern among many manufacturers about how the new Medical Device Regulation (MDR) will affect currently marketed devices, also known as “legacy devices”. Read more “MDCG issues guidance on legacy device certification issues surrounding the new MDR”
Did you know that certain Class I devices could get four extra years to comply with EU MDR?
A decision is soon expected on a corrigendum initiated in May by the European Commission (EC), to extend the existing transition period for certain class I reusable devices, including some software, that are being up-classified. Read more “Did you know that certain Class I devices could get four extra years to comply with EU MDR?”
Have you seen the IMDRF’s final clinical guidelines for medical devices?
The International Medical Device Regulators Forum (IMDRF) has released three final guidelines relating to clinical evaluations, clinical investigations and clinical evidence for medical devices. Read more “Have you seen the IMDRF’s final clinical guidelines for medical devices?”
How is a Two-year Delay to the Implementation of EUDAMED a Positive Opportunity for the Medical Device Industry?
The European Commission (EC) has announced a two-year delay to the implementation of it’s new EUDAMED database under the incoming Medical Device Regulation (MDR). Read more “How is a Two-year Delay to the Implementation of EUDAMED a Positive Opportunity for the Medical Device Industry?”
FDA proposes new warnings for breast implants
A draft guidance has been drawn up on the risks associated with saline or silicone gel filled breast implants, including recommendations of measures to ensure patients and physicians are mindful of them. Read more “FDA proposes new warnings for breast implants”
New guidance released by the MDCG regarding medical device software
The European Commission’s Medical Device Coordination Group (MDCG) have unveiled a guidance on qualification and classification of medical software under the new European Union’s (EU) Medical Devices Regulation (MDR) and In-Vitro Diagnostic Regulation (IVDR). Read more “New guidance released by the MDCG regarding medical device software”