REACH Compliance

‍REACH Compliance is the mandatory conformance requirements concerning Restricted Materials/Substances within a product, particularly those governed by specific European Union regulations.

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals.

REACH Compliance means adhering to regulatory standards that restrict or require the declaration of hazardous chemical substances in components, raw materials, or finished goods supplied to a manufacturer, ensuring product safety and conformity with specific EU mandates.

In the context of quality management, particularly within the medical device and life science supply chain, REACH compliance is a critical element of supplier agreements, ensuring that material inputs do not compromise regulatory standing or pose health risks.

Mandate within the Supply Chain

Compliance with REACH requirements is typically enforced through Supplier Quality Agreements.

Certification Requirement:

A supplier providing products (whether component, raw material, or finished goods) to a purchaser (such as Zimmer Biomet, an implied medical device manufacturer) must certify that these products conform to the latest REACH standards.

Parallel Compliance

Suppliers must demonstrate simultaneous compliance with REACH, RoHS, and conflict materials restrictive substances as defined by the United States Dodd-Frank Consumer Protection Act compliance standards.

Focus on Restricted Materials and Substances

REACH compliance specifically targets substances identified as highly hazardous in the EU regulatory framework:

Substances of Very High Concern (SVHC):

Per the Medical Device Regulation (Regulation (EU) 2017/746), compliance involves declaring Restricted Materials/Substances that are part of the Candidate list of Substance of Very High Concern (SVHC, REACH, Article 59 (10)).

Carcinogenic, Mutagenic, and Reprotoxic (CMR) Substances:

The restriction set forth in the regulation also applies to all carcinogenic, mutagenic and/or reprotoxic substances (CMR) of category 1.A and 1.B.

Endocrine Disruptors (ED): Compliance also requires adherence to restrictions regarding endocrine disruptors (ED) substances with serious effects on human health.

Integration with the EU Medical Device Regulation (MDR)

For medical device manufacturers, ensuring REACH conformance is integral to achieving overall compliance under the MDR:

• Article 10.4 of MDR: The supplier must comply with the Medical Devices Regulation (Regulation (EU) 2017/745) and certify that the products provided integrate the requirements described in Article 10.4 of the MDR (Annex I, General Safety and Performance Requirements).
• Supplier Declaration: Suppliers must declare compliance with these specific restricted substance lists to ensure the supplied materials meet the stringent quality requirements for medical devices.

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