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”
Category: Medical device
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?”
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A draft guidance has been drawn up on the risks associated with saline or silicone gel filled breast implants, including recommendations of measures to ensure patients and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”
The US FDA have finalised two guidances on guidewires, catheters and delivery systems
The United States (US) Food and Drug Administration (FDA) have issued two final guidances regarding performance tests and labelling considerations for intravascular guidewires, catheters and delivery systems. Read more “The US FDA have finalised two guidances on guidewires, catheters and delivery systems”
The Indian government will introduce a single regulatory framework for all medical devices
Between 2009 and 2015, India’s medical device industry grew by almost $2billlion. Read more “The Indian government will introduce a single regulatory framework for all medical devices”
How does the FDA plan to address safety concerns regarding metals in medical devices?
The United States (US) Food and Drug Administration (FDA) is continuing efforts to evaluate materials such as metals, used in devices, to ensure their safety and efficacy. Read more “How does the FDA plan to address safety concerns regarding metals in medical devices?”
73% of medical device makers say they will not be able to meet the full range of compliance criteria for the new EU MDR
A survey initiated by the Regulatory Affairs Professionals Society (RAPS) and the US tax, audit and advisory firm KPMG has established that only 27% of the 230 medical device makers who responded would be fully compliant with the new EU Medical Device Regulations (MDR), coming into effect on May 26th 2020. Read more “73% of medical device makers say they will not be able to meet the full range of compliance criteria for the new EU MDR”
Are you aware of the Department of Health and Social Care’s (DHSC) work with the industry on plans to minimise any medical supply disruption following a no-deal Brexit?
The Medicines and Healthcare Regulatory Agency (MHRA) have released guidance summarising their approach and actions to be taken by businesses supplying the United Kingdom (UK) with medicines from the European Union (EU), Iceland, Lichtenstein or Norway. Read more “Are you aware of the Department of Health and Social Care’s (DHSC) work with the industry on plans to minimise any medical supply disruption following a no-deal Brexit?”