MD+DI: REACH FAQs for Medical Device Professionals



REACH FAQs for Medical Device Professionals, a guest article by Nigel Syrotuck is featured in the November 30, 2018 Regulatory and Compliance section of MD+DI online.

Subtitled “The EU regulation may have been around for more than a decade, but there is still a lot for medtech to learn”, the article notes: “The hard truth is that medical devices aren’t exempt from this legislation, and complying with it is no small task. Following are the most frequently asked questions posed (to Syrotuck) by medical device developers and suppliers.”

Nigel provides useful information including A Background on REACH, Application to Medical Devices, Detailed Application of REACH, Obligations, and Top Tips for Understanding and Complying with REACH.

He concludes, “The most common problem that seems to occur with complex medical devices is designing a device around a critical component without knowing whether it is compliant with REACH. Always check your critical components before committing to a design.”

Nigel Syrotuck is a StarFish Medical Mechanical Engineer Team Lead and frequent contributor to the StarFish blog and guest blogger for medical device media including MD+DIMedical Product Outsourcing, and Medtech Intelligence.  He injects humour and imagination into projects big and small and blogs on everything in-between.


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