EU Medical Device Compliance: Regulations for Substances of Very High Concern

When it comes to your supply chain, having high quality materials that meet regulations is essential to developing high quality products for the end user. And there is perhaps no industry where this is more important than medical devices. People’s lives depend on the medical devices they use, and companies who want to keep their products on the market will need to meet strict compliance requirements and regulations for Substances of Very High Concern (SVHC) to keep their products safe.

In the European Union (EU), hazardous substance regulations also apply to medical devices, with a few differences to be aware of. In 2021, there is also the new EU Medical Device Regulation (MDR) companies will need to comply with. Keeping your products compliant with these regulations is not just important for your market access and brand reputation, it is also essential for people who depend on the medical devices you produce.

EU Medical Devices Regulation (MDR)

In May of 2021, the new EU MDR replaced the previous Medical Device Directive (MDD), introducing a broader scope for regulations. The purpose of EU MDR is to regulate substances within devices and products used in close contact with the human body. This can include everything from implanted devices to contact lenses.

To comply with the EU MDR, companies will need to understand their reporting burden, survey their supply chain, and appropriately report data to the European Data on Medical Devices (EUDAMED) database. In 2021, submissions to EUDAMED are voluntary but will become required in the future.

If you already have a medical device complying with the MDD, you may need to recertify your product under the MDR. All products sold in the EU must meet the EU MDR certification deadline by May 2024.

Medical Devices and REACH Compliance

Since EU REACH (Registration, Evaluation, and Authorisation of Chemicals) applies to almost every good entering the EU market, most sections of REACH also apply to medical devices. Companies manufacturing medical devices or supplying parts to medical devices will need to have a solid understanding of the chemicals and substances that go into their products in order to comply with REACH.

There are some small exceptions to REACH compliance for medical devices. For instance, if your medical device is already subject to a more specific medical device regulation, that regulation may override REACH.

Medical Devices and RoHS Compliance

The Restriction of Hazardous Substances (RoHS) directive was originally created to regulate products in the electronics industry. But since its inception, its scope has broadened. Many medical devices, both electronic and non-electronic, are now subject to RoHS regulations.

However, some RoHS regulations have applied differently to medical devices. A new RoHS directive (EU 2015/863) with an expanded list of restricted substances went into effect in July 2019. Medical devices have until July 22, 2021 to comply. The new list includes four new types of phthalates: Bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP), and diisobutyl phthalate (DIBP).

Medical Devices and SCIP Compliance

The newest requirement from the European Chemical Agency (ECHA) is the Substances of Concern in Products (SCIP) database. While many of the SCIP database requirements align with what is already expected in REACH, the new requirement does include some additional reporting.

Medical devices are subject to SCIP requirements if they a) meet the definition of an article under REACH and b) contains an SVHC on the Candidate List in a concentration above 0.1% weight by weight.

There are no exemptions for medical devices under SCIP. All suppliers and manufacturers are expected to input data into the SCIP database, enabling the SVHCs in a product to be tracked throughout the product’s lifecycle.

Get Medical Devices Reporting Support

Understanding the chemical make-up of your medical devices is essential not just for the safety of your products, but to keep your products on the EU market. Failure to comply can result not just in market loss, but also a loss of reputation as consumers lose trust in your products.

Developing a full materials declaration (FMD) for your products will help you to comply with regulations now and into the future. With an FMD, you’ll have all the information ready at your fingertips for quick compliance whenever new regulations are introduced.

For support in keeping your medical devices compliant with EU SVHC regulations, contact Tetra Tech’s experts at [email protected]. We can help you understand your compliance requirements, survey your supply chain, and answer any questions you have about EU medical device regulations.

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