Which medical devices fall under the EU MDR scope?
By when do I need to update the Clinical Evaluation Report?
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released today a business plan for the upcoming year, noting its primary focus on developing a consensus around a proposed model for the future of the country’s regulation of medicines and medical devices following its departure from the EU.
The final texts of the new European medical device and in vitro diagnostic (IVD) regulations were published today in the Official Journal of the European Union, setting in motion the timeline for implementation of the new regulations to commence on 25 May.
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Post-market surveillance is an important process for medical device developers, with regulatory bodies expecting you to follow through and have effective procedures.
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