In light of the disruption caused by the COVID19 pandemic in Europe, The European Commission has adopted a proposal to postpone the application date of the Medical Device Regulation MDR for one year.
This proposal is now expected to pass quickly through the European Parliament and Council, becoming law by the end of May 2020.
This is important news for Medilink members, the wider Medical Device sector and those organisations selling into European Union countries. The delay secures an essential extension for companies who have been working towards compliance, as the ongoing pandemic situation causes disruption to activities.
Whilst the delay will be welcome in many areas, it is not an indefinite suspension. Companies will still need to be fully compliant by May 2021, with many still reporting in a recent Innovate UK survey that there was a substantial amount of work to be done to meet the requirements of the MDR.
Now is the ideal time to begin addressing your compliance.
Medilink Regulatory and our network of approved regulatory associates are on hand to work with you on bringing your regulatory work up to MDR standard. Some key services include:
- MDR gap analysis
- Clinical Evaluation Report planning and authoring
- Technical File Review’
- Risk Management
- Post Market Surveillance
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Contact Medilink Regulatory on firstname.lastname@example.org or telephone 0114 232 9282 to discuss your requirements.