Medical Device Regulation Fall-Out Will Make EU Compliance Tricky For Years
European Regulatory Environment Has Become Hostile For SMEs
Medtech companies accessing the EU market must be fully compliant with the new Medical Device Regulation by 26 May 2024 – but the regulatory structure is incomplete and companies also have the ongoing pandemic to contend with.
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Common specifications, Eudamed arrangements and EU reference laboratories are all topics that should be addressed in EU legislative acts to assist with the implementation of the new medtech regulations.
Ensuring key standards are available for manufacturers to demonstrate compliance with the MDR and IVDR is one of the top priorities for the European Commission after the summer break.
BSI would have been disappointed if it had received the comments featured in the first expert panel opinion, but vice-president Gary Slack believes the report provides many insights and opportunities around how this scrutiny process will impact the sector.