REACH Regulations in the Medical Device Sector

REACH regulations are no small feat—about 45% of substances registered under standard registration undergo thorough compliance checks by the European Chemicals Agency (ECHA). For medical device manufacturers, achieving REACH compliance means meeting high standards that safeguard patient health while protecting the environment. 

But why is REACH so crucial, and how does it impact every step, from material selection to market entry? 

In this blog, we explore the importance of REACH compliance for medical devices, its scope, exceptions, and regulatory activities to make your compliance journey a smoother, safer market entry.

What is REACH Compliance for Medical Devices? 

REACH compliance in the medical device sector refers to adherence to the EU’s Regulation on Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH). This regulation requires companies to assess and document any chemicals used in their products to protect human health and the environment.

For the medical devices industry, compliance involves identifying and managing hazardous substances, particularly those that patients or healthcare workers might be exposed to during use. 

Meeting REACH standards ensure medical devices are safe, environmentally responsible, and permitted for distribution within the EU market. This compliance is critical for manufacturers targeting a global, regulatory-conscious audience.

Understanding REACH compliance is only the first step—it's essential to explore how these regulations specifically benefit the medical device sector. The importance of REACH compliance for the medical device sector is as follows:

Importance of REACH Regulations in the Medical Device Sector

• Access to EU Markets: REACH compliance opens doors to the lucrative European Union market, enabling companies to sell their medical devices across Europe without regulatory barriers.
• Health and Safety Assurance: REACH regulations protect patients and healthcare professionals by limiting exposure to harmful chemicals in medical devices and ensuring safer treatments and procedures.
• Environmental Protection: By restricting hazardous substances, REACH reduces environmental pollution and promotes sustainable manufacturing practices across the industry.
• Drive for Innovation: REACH compliance encourages manufacturers to explore safer, alternative materials, spurring innovation and sustainability within product development.
• Risk Management: REACH encourages thorough risk assessment of chemicals, helping manufacturers proactively address potential health hazards and product recalls.
• Enhanced Brand Reputation: Compliance demonstrates responsibility toward environmental health, strengthening the company's reputation with eco-conscious clients, investors, and consumers.

Internal audits are essential for REACH compliance, but tracking changes can get complex. BPRHub’s Audit Hub simplifies this with real-time compliance checks, instant status updates, and corrective actions, ensuring you stay audit-ready and fully compliant.

Understanding REACH Compliance for Medical Devices

REACH compliance for medical devices depends on their composition and function. Devices are categorized into chemical substances/mixtures or articles, each with distinct requirements. This session explores the compliance obligations for both categories, focusing on registration, chemical substance management, and manufacturer/importer responsibilities to ensure adherence to EU regulations. 

1.Scope

REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals) sets distinct requirements for medical devices based on their composition and intended use. Under REACH, medical devices are categorized into two main groups based on their function and chemical structure, with specific compliance obligations for each. 

a. Categories of Medical Devices Under REACH

1. Chemical Substances and Mixtures

• The majority of REACH requirements apply to devices classified as chemical substances or mixtures, such as lubricants, dental filling materials, and bone cement.
• These devices must undergo REACH registration unless they qualify for specific exemptions, as outlined in the regulation.

2.Articles

• Articles are defined as objects with functions determined by their shape, surface, or design rather than their chemical composition (Article 3.3 of REACH). Examples include blood glucose meters, catheters, and contact lenses.
• Most medical devices likely qualify as articles under REACH. Articles are not generally subject to REACH requirements unless they contain specific chemical substances regulated by REACH.

b. Obligations for Manufacturers and Importers of Articles

1. Registration of Substances in Articles

Registration is required if a substance in the article meets two conditions:

• It is present in quantities exceeding one tonne per producer or importer per year.
• It is intended to be released under normal or foreseeable use conditions (Article 7.1, REACH).

2. Notification to the European Chemicals Agency (ECHA)

Notification is mandatory if the article contains Substances of Very High Concern (SVHC) listed on ECHA's Candidate list that meets both of these criteria:

• Present in quantities over one tonne per producer or importer annually.
• Present above a concentration of 0.1% (weight by weight).

3. Communication of SVHC Information

For articles containing SVHCs in concentrations above 0.1%, the supplier must provide safe-use information on request within 45 days, including the SVHC's name at minimum. This information must be available to:

• Industrial or professional users and distributors.
• Consumers who request it for their safety.

2. Exceptions

Under REACH, medical devices may qualify for specific exemptions that lessen the compliance burden, particularly when other EU regulations apply. These exemptions recognize the distinct safety and classification standards already imposed by medical device regulations.

a.  Supply Chain Information Exemption (Title IV)

Because invasive medical devices already follow strict EU safety guidelines, REACH doesn’t require additional reporting here. However, this exemption mainly applies to mixtures, so most devices—often classified as “articles”—are unaffected.

REACH’s Title IV, which requires detailed supply chain information about hazardous substances, does not apply if all these conditions are met (Article 2.6(c), REACH):

• The device is a mixture (like a gel or lubricant).
• It is invasive or comes into direct contact with the human body.
• Other EU regulations already require labeling or classification of dangerous substances or chemical mixtures in the device.

b.   Exemption Under Sector-Specific EU Medical Device Legislation

For devices covered by these specific directives, REACH applies only to areas not covered by these existing laws. Suppose a device uses a substance on REACH’s Annex XIV (restricted substances). In that case, the manufacturer does not need to reassess health or environmental risks, as the medical device regulations already manage these.

Devices governed by specific EU medical laws are partially exempt from REACH. It includes:

• Directive 90/385/EEC for active implantable medical devices.
• Directive 93/42/EEC for general medical devices.
• Directive 98/79/EEC for in vitro diagnostic devices.

REACH regulations demand extensive documentation and strict compliance, which can quickly become overwhelming. BPRHub’s Document Hub centralizes all compliance paperwork, streamlining updates, approvals, and storage in one secure location.

3. Regulatory Activities

Compliance with REACH requires engaging in multiple regulatory activities, including registration, evaluation, and authorization of substances. Ensuring REACH compliance in medical devices involves several regulatory activities that manufacturers must follow to meet EU standards. Below is a detailed breakdown of these requirements:

    a. Regulatory Compliance Requirements

Medical devices must meet safety and performance requirements outlined in Annex I of the regulation. The several assessments of compliance are:

• Clinical Evaluation (Annex XIV): Evaluates the clinical safety and performance of the device.
• Conformity Assessment Procedure (Annexes IX, X, and XI): This procedure ensures that devices meet the regulatory standards before market entry.
• Technical Documentation (Annex II): Provides detailed information on the device’s design, function, and compliance measures.
• EU Declaration of Conformity (Article 19): Confirms that the device meets all regulatory requirements.
• CE Marking (Article 20): Symbolizes that the device complies with EU standards and can be sold in the EU market.

As per Article 15, manufacturers must appoint at least one individual to oversee regulatory compliance to ensure that all requirements are met consistently.

     b. Labeling and Instructions

• Labeling Standards
  • As specified in Annex I, medical devices must adhere to specific labeling guidelines that provide essential safety and usage information.
• Instructions for Use
  • To ensure patient and user safety, detailed instructions for proper usage must be provided. These instructions cover operational details, precautions, and information on potential hazards.

      c. Registration of Devices and Stakeholders

• Unique Device Identification (UDI-DI)some text
  • Each device must have a unique device identifier (UDI-DI) assigned under Article 29 to enable traceability.
• Registration of Manufacturers, Representatives, and Importerssome text
  • Manufacturers' authorized representatives and importers must be registered under Articles 30 and 31 to ensure accountability within the supply chain and compliance with EU regulations.

     d. Post-Market Surveillance

Ongoing Monitoring (Articles 83-101)

• Post-market surveillance is mandatory to monitor device performance and address any issues after the device is available to consumers. This includes gathering feedback, tracking adverse events, and making updates to the device if needed.
• To protect patients and users, manufacturers must establish and maintain a system for continuous assessment of their devices' safety and effectiveness.

      e. Requirements for Supply Interruption

• Notification of Anticipated Supply Disruptionssome text
  • Suppose a manufacturer foresees an interruption or discontinuation in the supply of a non-custom-made device that could harm patients or public health. In that case, they must notify the relevant authorities at least six months in advance (Article 10a).
• Communication Obligationssome text
  • The manufacturer must inform the national authority in the country of operation, as well as relevant economic operators, healthcare facilities, and professionals who directly receive the device.
  • Other operators in the supply chain must then pass this information to their respective clients and contacts without delay.

REACH regulations involve a complex compliance process, which is often overwhelming for medical device manufacturers due to multiple standards and detailed requirements.   

How BPRHub Eases the Path to REACH Compliance

Medical device manufacturers often find it challenging to achieve REACH compliance due to the detailed documentation and strict regulatory requirements involved. BPRHub, a cloud-based compliance management platform, simplifies this journey by automating compliance tasks, streamlining workflows, and enabling data-driven decisions.

BPRHub’s platform guides you through each step, from registration and risk assessments to labeling and post-market surveillance, ensuring your devices meet EU standards while staying current with REACH exemptions. By using BPRHub, manufacturers can reduce regulatory risks, boost operational efficiency, and focus on growing their presence in the European market with confidence.

Achieving REACH compliance doesn’t have to be overwhelming; choose BPRHub, stay up-to-date with the latest regulations, and reduce the risk of non-compliance penalties

FAQ’s

1.What are the REACH regulations?

Ans: REACH regulations (Registration, Evaluation, Authorisation, and Restriction of Chemicals) aim to protect human health and the environment by controlling the use of chemicals. It requires manufacturers to register chemicals, assess risks, and manage hazardous substances in products, ensuring safety and compliance within the EU market.

2.What are the regulatory requirements for REACH?

Ans: REACH regulatory requirements include registering substances with the ECHA, evaluating chemical risks, and authorizing or restricting certain hazardous substances. Manufacturers must provide safety information, label products accurately, notify about Substances of Very High Concern (SVHC), and manage post-market surveillance to ensure compliance with EU standards and protect health and the environment.

3.How does BPRHub support manufacturers in keeping REACH documentation organized?

Ans: BPRHub’s Document Hub centralizes all compliance-related documentation, ensuring easy updates, approvals, and secure storage. This feature streamlines the management of REACH-related paperwork, enabling manufacturers to track changes, maintain audit readiness, and stay compliant with evolving regulatory requirements.

4.What is REACH compliance, and why is it important for medical devices?

Ans: REACH compliance ensures medical devices meet EU regulations for the safe use of chemicals, protecting human health and the environment. It is critical for market access, ensuring safer products, environmental responsibility, and enhanced brand reputation in the European market.

5.Are medical devices exempt from REACH? 

Ans: Medical devices are not fully exempt from REACH. However, certain exemptions apply, such as for devices already regulated under specific EU medical device laws. These exemptions reduce the compliance burden, particularly for invasive devices or those that meet specific safety criteria.