In the fast-paced and ever-evolving world of medical device manufacturing, achieving regulatory product compliance is no easy feat. With over 800 regulations worldwide, including REACH, RoHS, PFAS, and SCIP, navigating the complex web of standards can feel like an insurmountable challenge. Every step of the process requires meticulous attention to detail and a deep understanding of the regulations that govern the industry. From staying current with ever-changing obligations to conducting thorough due diligence, the demands on manufacturers are overwhelming.
Effectively managing compliance is a common challenge that companies face, whether they choose to handle it in-house or outsource it. However, by adopting product compliance best practices or partnering with a supply chain solution provider, companies can effectively navigate these challenges and ensure their programs run smoothly. Regardless of the chosen approach, the goal should be finding a solution that helps businesses remain compliant and reduce risks. With the ever-increasing importance of compliance in today's regulatory landscape, companies must prioritize finding the right compliance solution to safeguard their operations and reputation.
This e-book provides a comprehensive guide to product compliance in medical device manufacturing. It covers the regulatory landscape—including standards like REACH, RoHS, PFAS, SCIP, and the EU MDR—and examines common challenges in managing compliance. It also outlines best practices for in-house compliance management and demonstrates how leveraging advanced compliance software can streamline processes. Finally, it shows how Source Intelligence’s product compliance solutions empower your organization to efficiently meet evolving regulatory requirements and reduce risk.
Achieving regulatory product compliance in the medical device manufacturing industry requires a deep understanding of the complex regulations and standards that govern the sector. The most common regulations companies in the medical device manufacturing space must comply with are REACH, RoHS, PFAS, SCIP, TSCA, and the EU MDR.
The EU Medical Device Regulation (MDR) (2017/745) is a regulatory framework that governs the production and distribution of medical devices in the EU. It was adopted in 2017 and implemented on May 26, 2021, replacing the EU Medical Devices Directive (MDD) (93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD) (90/385/EEC). It intends to ensure that medical devices in the EU meet strict safety and quality standards while supporting fair market access.
The regulation restricts the use of certain hazardous substances in the design and manufacturing of medical devices and establishes reporting requirements for devices containing any restricted substances over a certain threshold. Medical device companies (i.e., legal manufacturers) that intend to sell or distribute their products within the EU member states must comply. EU MDR compliance ensures that medical devices are safe, high-quality, and well-designed for the safety of providers and patients.
Managing product compliance in-house can be daunting, requiring a significant investment of internal resources and regulatory compliance expertise. However, with the right approach and dedication, it is possible to successfully meet your product compliance obligations. Companies must be prepared to allocate the necessary resources to their compliance program and utilize best practices to ensure its success. By taking control of product compliance in-house, companies can comprehensively understand their obligations and maintain a high level of control over the process. This helps companies ensure compliance with applicable regulations, enhances their reputation, and builds trust with customers.
The complexities and challenges of managing product compliance in-house can be simplified by following industry best practices. The regulatory experts at Source Intelligence have identified six key best practices that can help companies successfully manage their product compliance programs.
Being as self-sufficient as possible regarding data collection is an effective way to reduce supplier fatigue, starting with understanding how to find the appropriate documentation online to fulfill your data requests. Compliance documentation is often available on supplier websites, so it’s best practice to thoroughly search for the required data online before reaching out to suppliers. Requesting supplier data via phone or email can frustrate and fatigue suppliers when the information is publicly available.
Obtaining compliance information online will vary depending on the supplier. Some suppliers may require creating an account to access the information. Other suppliers may provide part-specific details on their website’s product pages or have a specific webpage dedicated to compliance data. If the compliance information is not available on the supplier’s website (or the data on the website is insufficient), further research to identify the appropriate contact to request the information is required.
Reaching out to the most relevant department with information requests helps save time. For example, contacting the supplier via the purchasing or sales department may not be the most effective route. Quality, compliance, and engineering departments are better suited to fulfill the request in a timely manner. Suppliers may also have a specific email address for compliance requests.
Accepting evidentiary compliance data in any format available greatly reduces the supplier’s effort, yielding a higher response rate and lower turnaround time. Some suppliers may have company policies that prohibit them from completing customer-submitted forms, while others may not have adequate internal capabilities to complete custom forms.
Examples of commonly used formats for compliance information include:
Evidentiary documentation accumulates quickly during a robust compliance effort. Once the necessary compliance information has been collected and analyzed, it should be compiled and organized. To effectively utilize documentation already on file, it is necessary to have a compliance system in place that can house documentation and associate the documentation to specific purchased parts. In some cases, previously provided supplier documentation can be applied to newly procured components if they are similar, or if the previous documentation was provided at the company level. Making use of company documentation and product family declarations decreases the need to request new data from suppliers, which helps avoid fatigue.
Elevate your medical device compliance
You've just explored the core regulatory landscape and initial strategies for managing product compliance in medical device manufacturing. Next, the e-book dives deeper into optimizing internal processes and leveraging advanced compliance software—showing how Source Intelligence’s product compliance solutions can reduce risk and enhance efficiency.
Read the complete e-book to transform your compliance approach and safeguard your market presence.