MEDIcept Insights
EUDAMED Database – Progress Updates
EUDAMED is one of the key elements of the European Medical Devices Regulation (EU) 2017/745 (MDR) and the In-Vitro Diagnostic Medical Devices Regulations (EU) 2017/746 (IVDR).
The FDA and Medical Device Cybersecurity
Healthcare providers are a prime target for cyberattacks due to many interconnected medical devices and the sensitive patient data they house.
Are Your Policy And Procedures In Place To Be Recall Ready?
If you are a medical device manufacturer, it is crucial to have the necessary recall policies and procedures in place to handle a potential field action quickly and effectively. A product recall can be costly and damaging to a company's reputation, so it's essential...
FDA’s Digital Health Center of Excellence: Recent Activities and Plan for the Future
The FDA's Digital Health Center of Excellence (DHCoE), founded in 2020, is a resource for both industry and the public, intending to accelerate innovation in digital health. Recently, they've been involved in several pilots and activities to promote digital health...
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...