International – REACH FAQs for Medical Device Professionals

The EU regulation may have been around for more than a decade, but there is still a lot for medtech to learn..

REACH stands for Registration, Evaluation, and Authorisation of Chemicals. It is European Union Regulation No 1907/2006. It has many objectives, the most pertinent of which to medical devices is to improve the protection of human health and the environment. At over 1000 pages long, it’s been described as the most complex in EU History.

Now that REACH is in full effect, I am often asked about the scope, application, and obligations for medical devices. 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 me by medical device developers and suppliers.

A Background on REACH

Is it like RoHS 2011/65/EU?

It’s kind of like RoHS on steroids, but it doesn’t just apply to electronic equipment, and instead of one list, there are three! There are a bunch of other small but important differences, too.

Would it be simpler to understand the differences between REACH and RoHS as opposed to learning from scratch?

What are the three REACH lists?

  • Substances of Very High Concern (SVHC) list. These are chemicals for which the harms to human health or the environment are thought to outweigh the benefits, but that hasn’t been fully assessed yet. Items on the SVHC list can be thought of as “in the queue” to possibly be in one of the next two lists while the European Chemicals Agency (ECHA) and the public make their cases for and against.
  • Authorization list. These are chemicals known to be harmful to human health and/or the environment, but manufacturers can apply for authorization to use them anyway. A manufacturer must show that there are no safer alternatives, and it’s better overall for the public to use that chemical for a certain application than to not be allowed to use it at all. All authorizations are application specific and are posted publicly. Medical devices need not address REACH-driven risks to human health when applying for authorization (this is presumably because risks to human health must be considered as part of the medical device regulatory process anyway).
  • Restricted list. These are chemicals known to be harmful to human health and/or the environment. Opposite of authorized, they are restricted for certain applications but are permissible for applications not addressed…