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?”

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?”