REACH in the Medical Device Sector

REACH Compliance for EU Medical Devices

As REACH (Registration, Evaluation, and Authorization of Chemicals – EU Regulation No 1907/2006) is in full force, medical devices also need to follow this legislation - if you are an EU manufacturer / importing to EU. Unlike ROHS, REACH applies to everything – from raw materials to finished goods.

REACH applies to each subcomponent called article – even manuals, packaging boxes. All the regulated/restricted substances are compared concerning the weight of the article (subcomponent). That is, you cannot use a non-compliant article on a very heavy device. Therefore, you need to go deeper into your BOM to see if it contains any substances listed out in – SVHC, Authorization, or Restricted substance list.

Understanding REACH Substance Lists

You have to comply with three REACH substance lists:

1. The substance of Very High Concern (SVHC) List – It consists of chemicals, which harm human health/environment. The list keeps updating every 6 months. As per the latest updated SVHC list (June 2021), there are 219 substances. If any of these substances are present in your product – more than the threshold limit (0.1% at article level), you have to submit a substance declaration in form of SCIP submission to the authorities and communicate the same information to all your customer's using-declaration letters. In addition, if you are importing more than 1 ton of that substance, you must notify ECHA (European Chemicals Agency)

2. Authorization list – These are also harmful chemicals, but manufacturers can use them if there are no other safer alternatives for their use. Therefore, in that case, you have to apply for Authorization from ECHA. This step will be easier as medical devices will be considering this step for complying with EU Medical Device Regulation

3. Restricted list – This is the list of chemicals, which are restricted in certain applications but are allowed for applications not addressed. Make sure your application is not restricted and you will need to replace the component if it is restricted.

Compliance Requirements for Manufacturers

So reach out to your supply chain to get material information of the product that they supplied to you. If any of your suppliers are not able to provide information, consider an alternate supplier or do physical testing for devices that have already been placed in the EU market.

Material Management in Supply Chains

REACH material lists are updated every 6 months, and the ECHA clearly states that your information should not expire more than 6 months. So you should re-audit your device every 6 months. REACH exemptions for medical devices

• 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 use of an Annex XIV material when required, as part of an in vitro diagnostic (IVD) procedure (eg a reagent, calibrator, control material, or kit) is excluded from the approval requirements - activity is carried out under controlled conditions and in a volume not exceeding one tonne per year per legal entity.

The most common problem that seems to occur in complex medical devices is the designing of a device around a critical component without knowing whether the device is REACH compliant. Always check your critical elements before making a design.

Reference: SVHC candidate list: https://echa.europa.eu/candidate-list-table
Restriction list- Annex XVII: https://echa.europa.eu/substances-restricted-under-reach