Regulatory & trade
EU MDR 2017/745
Also called: Medical Device Regulation, CE marking
EU MDR 2017/745 — The European Union Medical Device Regulation, which sets the requirements a device must meet to carry the CE mark in the EU.
The MDR replaced the earlier Medical Device Directive and tightened requirements on clinical evidence, post-market surveillance and traceability. Devices are classified by risk, and most classes need a notified body to review conformity.
In Pakistan, CE marking is commonly accepted as supporting evidence in DRAP registration and tender files. Check the declaration of conformity and certificate cover the exact product and size range offered.
Related termsISO 13485Free Sale CertificateDRAP
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