EU to Delay Portions of the IVDR Rollout

The European Union had recently proposed doing what the medical device industry has been urging for years – delaying the implementation of certain aspects of the In Vitro Diagnostic Medical Devices Regulation (IVDR) that is slated to replace the current In Vitro...

Medical Device Regulatory Changes in the Post-Brexit UK

If you are currently selling, or planning to sell, medical devices in the United Kingdom, the clock is ticking for Class III, IIb, IIa, and I devices. As of January 1, 2022, the UK Medicines and Healthcare products Regulatory Agency (MHRA) has mandated that all...