The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes ...
Following its recent departure from the EU, the UK has introduced a new medical device information system (MDIS) that requires all medical devices available on the UK market to be registered with the ...
Cambridge, UK - Regulatory compliance in medical device development is often treated as a hurdle to be cleared late in a programme. In practice, addressing it too late can introduce significant ...
Roche Diagnostics is the first manufacturer to score certification for a class D product under the new in vitro diagnostic regulation (IVDR). TÜV SÜD Product Service issued the IVDR certificate. TÜV ...
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