RECOM's MDR Checklist for Medical Manufacturers
Mar 20, 2019
The European Commission (EC) has determined that the existing European Union (EU) Medical Device Directive (MDD) is not sufficiently stringent and has been recast as a regulation – the Medical Device Regulation (MDR).
The difference between a directive and a regulation is that all member states in the EU are legally bound to abide by a regulation without any modifications (it enters law immediately). The EC can also take measures to penalize countries, manufacturers, importers, distributors, or even individuals if it determines that any violations have occurred and local authorities have not adequately enforced compliance. The wording used in a regulation is necessarily strict.
The MDR applies to all medical device manufacturers, meaning every manufacturer of a medical device or accessory has new obligations. The MDR uniquely defines job descriptions for staff that manufacturers must employ to remain in the medical market. It also assigns notified bodies extra duties, transforming them into regulatory oversight organizations rather than just industry certification partners.
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The MDR applies to all medical device manufacturers, meaning every manufacturer of a medical device or accessory has new obligations. The MDR uniquely defines job descriptions for staff that manufacturers must employ to remain in the medical market. It also assigns notified bodies extra duties, transforming them into regulatory oversight organizations rather than just industry certification partners.
RECOM's MDR Checklist for Medical Manufacturers
The following checklist from RECOM may assist manufacturers seeking to remain in the medical market after 2024:- Importers and Distributors: You will have the same responsibilities and liabilities as manufacturers. Without direct contact with the original manufacturer, including access to the design team, supply chain management, and production, meeting regulatory requirements for traceability and post-market surveillance will be challenging.
- Component Manufacturers: If you produce a component that is not classified as a medical device (e.g., a power supply), you will not be required to conduct clinical trials or apply for a unique identification code. However, you must still support and respond to any adverse results from the product’s use in a medical device over its lifespan. Assigning a serial number to each supplied product, linked to full documentation (production testing results, quality management system, bill of materials), is advisable. A simple date code identifier may be insufficient.
- Risk Assessment: If the supplied part presents a potential hazard (electrical, thermal, sharp edges, radiation), you must conduct a risk management assessment. This assessment goes beyond basic safety or EMC certifications and requires ongoing and periodic reassessments. You must also regularly contact each customer who has purchased the product throughout its lifecycle. Establishing a contractual agreement with customers to formalize this process is recommended.
- Notified Body (NB) Availability: There are not enough notified bodies accredited to meet medical device regulation requirements. New medical products may experience delayed market entry due to limited NB availability. Additionally, expect increased costs as demand surpasses supply.
- Regulatory Compliance Expertise: Manufacturers must have an in-house expert responsible for regulatory compliance with knowledge in the field of medical device compliance. If no such specialist is available internally, an arrangement with an external consultant will be necessary.
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