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?
Perhaps. Read this article to see a comparison.
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.
Are the lists ever updated?
Yes, usually every 6 months.
Application to Medical Devices
Does REACH apply to my medical device?
Yes, if you’re importing it to Europe.
What if it’s an exploratory medical device for a clinical trial?
Substances used for “scientific research and development” are exempt from the requirements of both Restriction (Article 61, Section 1) and Authorization (Article 56, Section 3). The legislation appears to be unclear whether this extends to SVHCs.
What if the device is being removed from the EU after a clinical trial?
Removing the device/substance after a trial appears to be mostly irrelevant, however, applications for authorization do consider the waste removal process.
But my medical device isn’t even electronic!
Unlike RoHS, REACH applies to everything – even simple medical devices like scalpels. For context, it even applies to clothes!
My medical device is a finished good, not a chemical, so isn’t this moot?
No, REACH applies to finished goods as well as to raw chemicals.
Does REACH have any exemptions for medical devices?
Not really. The only provisions for medical devices surround communications requirements and the methods the Commission takes to determine whether a substance should be authorized for certain uses. For instance, Perfluorooctanoic Acids are permitted in medical devices until 2032.
Does REACH apply to the box that my medical device is shipped in?
Yes. Everything imported into the EU is subject to REACH.
Does REACH apply if I import less than 1 ton of my medical devices per year?
Yes, the 1-ton limit is for registration of chemicals, which is not addressed in this FAQ.
Does REACH apply if I import less than 1 ton of a particular substance per year? For example, what if my medical device contains only a small amount of an SVHC?
Yes, although you aren’t required to communicate with the ECHA to the same extent as you would be if you imported more of that SVHC.
Detailed Application of REACH
Does REACH apply to my whole device or to each individual subcomponent?
Each individual subcomponent, called an “article,” must be assessed for compliance with REACH. See this guidance for details of these terms to determine how deep into your BoM you must go.
Is there a lower limit?
For SVHCs and authorized substances, nothing below 0.1% w/w would need to be considered. Restriction conditions can, however, set higher or lower limits than 0.1%.
Is the weight of the substance compared to weight of the finished device?
No, it applies to each subcomponent (or article).
So, if my device weighs 100 kg, but a subcomponent (or article) contains only 1 g of a substance on one of the lists, I am good?
No. That article must be compliant with REACH all on its own – you can’t drop a non-compliant article into a really heavy device and call it a day. Therefore, that article would have to weigh at least 1 kg to be compliant on its own should it contain 1 g of a substance on one of the lists.
Can an article contain more than one substance on one of the lists?
Yes. In the example above, if the 1-kg article contained 1 g of an SVHC, 1 g of another SVHC, and 1 g of an authorized substance (for example), it would be compliant with REACH.
Can I see some detailed examples?
Read the ECHA’s guidance on this subject here – it’s loaded with examples.
What do I have to do for my medical device?
REACH is a self-certification activity, so you have to assess your device on a component-to-component basis to find out whether it contains any SVHCs, authorized substances, or restricted substances, and take appropriate action if it does. Yes, this is a lot of work.
What if my device is already on the market?
Any devices already imported into the EU are not subject to REACH, but any that haven’t are. So, if you’re a North American manufacturer, REACH applies to all units not yet arrived in Europe.
What actions must I take if a component in my device does contain one or more substances on one of the lists, over the minimum weight threshold?
- SVHC. You must inform your distributor, or, if you sell directly to European consumers, have that information available and provide it upon request. Furthermore, if you are importing more than 1 ton of that substance, then you must inform the ECHA.
- Authorized. You must seek an authorization for your specific application or substitute the part for another option without the substance.
- Restricted. Check to make sure that your application is what is restricted, otherwise you’re all good. If your application is restricted, you’ll have to substitute the component.
How do I find out what is in my device?
The simple answer is to ask the suppliers of your subcomponents. They should be able to send you information on the content of the component they’ve sold you. If they don’t have it handy, they may have to ask their own suppliers.
What if they can’t tell me what’s in the articles they supply?
If they can’t provide information on their products, consider an alternate supplier. If there is no alternative supplier available for that particular component, you may be painted into a corner. Physical testing is a common last resort.
Do I have to re-audit my device every 6 months when the lists are updated?
This guidance clearly states (section 3.4.2) that you be no more than 6 months out of date on your information; however, it is worth noting that timeframe applies to suppliers at the top of the supply chain, too. Therefore your suppliers would have to work more quickly than the letter of the law to allow you to keep up.
Is there anything else I should know?
Yes - lots. It would take a good chunk of a lifetime to fully understand REACH. Don’t rely on this FAQ as your only source of information.
Top Tips for Understanding and Complying with REACH
A chemical, when talking about REACH, isn’t an ethereal green liquid you’d find in a flask in a laboratory. It’s anything and everything that make up our physical world, from metal alloys to plastics to silicone in resistors. There is a much more accurate definition in the legislation, but if you’re only interested in the big picture, this is probably the best definition to remember.
Also, 99% of the battle is finding out what is in your device. After that, the process if fairly clear and predictable – replace any substances or components you need to, and inform your customers or the ECHA if so required.
Many vendors supply REACH information easily; many do not. Choose your vendors wisely and early. For some reason, electronics vendors tend to be more likely to supply REACH information, perhaps because they learned the value of getting on top of things years ago when RoHS was first implemented.
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.
Please note: these questions and answers are not endorsed by the ECHA and do not represent official responses in any way. They are a based on my understanding of the legislature and its implementation.