Meet Your Regulatory Compliance Requirements

Strategies for Managing Compliance

When introducing a new medical device, ODMs and OEMs must initiate well-defined risk analysis and evaluation phases. Establishing risk management assessment processes is critical to ensure that manufacturers take into account the necessary risk analysis, evaluation, control, and corrective actions throughout new product introduction (NPI) and post-production. 

Medical device companies must comply with both industry-specific and universal standards and regulations for marketing product. Industry standards and regulations include International Standards Organization (ISO) 13485, ISO 14971, Food and Drug Administration (FDA) 21 CFR Part 820, and FDA 21 CFR Part 11. Environmental standards and regulations include Restriction of Hazardous Substances (RoHS), Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Waste from Electrical and Electronic Equipment (WEEE), and conflict minerals. 

Medical Device Specific Compliance

Each medical device regulation introduces the need to establish and manage current good manufacturing practices (CGMP) to reduce risks.³ Problems identified during the design, development, and use of a device can often be eliminated with the review of a medical device company’s multidisciplinary team. A product-centric QMS solution simplifies compliance by providing every team visibility to all processes, and enabling them to collaborate in real time to address design or production issues.

Teams participating in the risk assessment and management evaluation process should consider these questions:

• What is the intended use of the product?
• Is energy or a substance delivered to or extracted from the patient?
• Is the device to be routinely cleaned or disinfected by the user?
• Are measurements taken? Is maintenance or calibration necessary?
• Is the medical device susceptible to environmental influences?
• Does the medical device have software?
• Does the product have a shelf life, and what determines its useful life?
• Does product installation or use require special training?

Once the risk elements and hazards of the product design are identified, an analysis of each element can be performed.

Environmental Compliance

RoHS, REACH, WEEE, and conflict minerals

Any business, including medical device companies, that sells applicable electrical or electronic products, equipment, sub-assemblies, cables, components, or spare parts directly to RoHS (Restriction of Hazardous Substances) countries, or sells to resellers, distributors, or integrators that in turn sell products to these countries, is impacted if they use any of the restricted 10 substances. A component database integrated with their product-centric QMS solution helps medical device companies dramatically reduce environmental hazard compliance risks.

RoHS specifies maximum levels for the following 10 restricted substances. The first six applied to the original RoHS while the last four were added under RoHS 3.

• Cadmium (Cd): < 100 ppm
• Lead (Pb): < 1000 ppm
• Mercury (Hg): < 1000 ppm
• Hexavalent Chromium (Cr VI): < 1000 ppm
• Polybrominated Biphenyls (PBB): < 1000 ppm
• Polybrominated Diphenyl Ethers (PBDE): < 1000 ppm
• Bis(2-Ethylhexyl) phthalate (DEHP): < 1000 ppm
• Benzyl butyl phthalate (BBP): < 1000 ppm
• Dibutyl phthalate (DBP): < 1000 ppm
• Diisobutyl phthalate (DIBP): < 1000 ppm

Source: RoHS Guide Compliance⁴

Types of hazards can include energy, biological, environmental, software, user error, labeling, complexity of use, and functional failure. In addition to the chemicals regulation REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), medical device companies that want to sell their products globally must report on the use of certain hazardous substances per the RoHS directive.⁵

RoHS applies to a wide array of medical devices including:

• Radiotherapy equipment
• Cardiology
• Dialysis
• Pulmonary ventilators
• Nuclear medicine
• Laboratory equipment
• In-vitro diagnostic devices
• Other appliances for detecting, preventing, monitoring, treating, or alleviating illness, injury, or disability

The WEEE Directive aims to minimize the impact of electrical and electronic goods on the environment by increasing reuse and recycling to reduce the amount of waste of electrical and electrical equipment going to landfills. WEEE dovetails with RoHS efforts to reduce hazardous materials in electronics products. Category four and five medical devices are subject to recovery and recycling targets under WEEE.

In addition, responsible sourcing and reporting of conflict minerals is necessary to demonstrate due diligence. Environmental regulations are an integral part of medical device product design. Documenting and tracking the components and raw materials that are used for production must occur throughout the entire lifecycle. Because of this, OEMs, distributors, and contract manufacturers rely on component databases like SiliconExpert and Octopart to manage substance declarations. A component database is the only practical and cost-effective way to comply with ever-changing compliance mandates and frequent updates. Linking your product-centric QMS solution to these types of component databases allows you to leverage the single source of product truth and maintain environmental compliance data.⁶

Arena’s Supplier Item Lookup provides regulatory and material availability information to eliminate risks to ensure compliant parts can be sourced when needed.

A component database improves product risk management and provides instant access to component documentation. When integrated into a QMS solution, component databases help medical device companies dramatically reduce environmental hazard compliance risks. Compliance with regulatory requirements across the product lifecycle ensures product integrity, minimizes legal risks, and maintains industry standards from development to market.