The European Union Medical Device Regulation (MDR) (EU) 2017/745, which took effect on May 26, 2021, represents a significant overhaul of the previous regulatory framework for medical devices, the Medical Device Directive (93/42/EEC) – often referred to as the MDD. For medical device distributors, understanding the key differences between these two sets of regulations is crucial for ensuring continued compliance and navigating the evolving landscape of the EU market. While the fundamental role of distributors in the supply chain remains, the MDR introduces more stringent requirements and greater scrutiny, impacting various aspects of their operations. This article provides a comprehensive overview of the essential differences between the MDR vs MDD that medical device distributors must be aware of.
Increased Scope and Device Classification
MDD: The scope of the MDD primarily covered medical devices but had some ambiguities regarding borderline products (e.g., some cosmetic products with medical claims). The classification system was largely based on risk, with classes I, IIa, IIb, and III.
MDR: The MDR expands the definition of a medical device to include certain aesthetic products without a medical purpose (Annex XVI). It also refines the classification rules, leading to the up-classification of some devices (e.g., certain software and active implantable devices without a direct medical purpose).
Impact on Distributors: Distributors need to be aware of the expanded scope to ensure that all products they handle that now fall under the MDR are treated accordingly. Changes in classification can affect the regulatory pathway and the information that must accompany the device.
Enhanced Requirements for Clinical Evidence
MDD: The requirements for clinical evidence varied depending on the device class, with lower-risk devices often relying on equivalence to predicate devices with less stringent evidence.
MDR: The MDR introduces significantly stricter requirements for clinical evidence for all device classes, emphasizing the need for high-quality data from clinical investigations, particularly for higher-risk devices. Equivalence is more tightly controlled and requires demonstrable equivalence in technical, biological, and clinical characteristics, along with manufacturer access to the predicate device’s technical documentation.
Impact on Distributors: While manufacturers bear the primary responsibility, distributors may need to be prepared to provide information to manufacturers regarding the real-world performance and any issues encountered with devices in the market, contributing to post-market clinical follow-up (PMCF) activities. They also need to ensure that the devices they distribute are backed by the necessary clinical evidence as demonstrated by the manufacturer’s documentation.
Greater Scrutiny of Notified Bodies
MDD: The oversight of Notified Bodies (NBs) varied across Member States.
MDR: The MDR introduces much stricter criteria for the designation and monitoring of NBs to ensure their competence and independence. This includes joint assessments by the European Commission and national authorities. NBs also face more frequent audits and increased scrutiny of their decisions.
Impact on Distributors: Delays in conformity assessment due to stricter NB processes can potentially affect the availability of certain devices. Distributors should maintain close communication with manufacturers regarding the CE certification status of the products they distribute. The enhanced credibility of NBs under the MDR should ultimately lead to greater confidence in the compliance of certified devices.
Introduction of the Person Responsible for Regulatory Compliance (PRRC)
MDD: The MDD did not mandate a specific role equivalent to the PRRC.
MDR: Article 15 of the MDR requires manufacturers to have a Person Responsible for Regulatory Compliance (PRRC) with the necessary expertise. Micro and small enterprises can have permanent and continuous access to a PRRC.
Impact on Distributors: While distributors are generally not required to have a PRRC (unless they assume manufacturer obligations under Article 16), the presence of a PRRC at the manufacturer level should lead to improved regulatory oversight and potentially better quality and compliance of the devices they distribute. Distributors may need to interact with the manufacturer’s PRRC on regulatory matters.
Strengthened Post-Market Surveillance (PMS) and Vigilance
MDD: PMS requirements were less detailed, and vigilance reporting thresholds varied.
MDR: The MDR significantly strengthens PMS requirements for manufacturers, mandating proactive collection and analysis of post-market data, including PMCF. Vigilance reporting requirements are also more stringent, with clearer timelines and reporting obligations for serious incidents and trends.
Impact on Distributors: Distributors play a crucial role in PMS by forwarding complaints and information about adverse events or device malfunctions they receive from the market to the manufacturer (and potentially competent authorities). They need to establish clear internal procedures for this. The enhanced PMS should lead to quicker identification and correction of safety issues, benefiting the entire supply chain and end-users.
Enhanced Traceability
MDD: Traceability requirements were less comprehensive.
MDR: The MDR introduces the Unique Device Identification (UDI) system, which mandates the placement of a UDI on devices and their packaging. Economic operators, including distributors, have obligations related to the UDI. Distributors are required to store and keep, preferably by electronic means, the UDI of the devices they have supplied and the UDI of the devices supplied to them, particularly for implantable devices and Class III devices.
Impact on Distributors: Implementing systems to record and maintain UDI information is a new and significant requirement for distributors. This will necessitate investments in IT infrastructure and changes to logistics processes to ensure compliance with the MDR traceability requirements. Accurate UDI tracking is crucial for effective recalls and market surveillance.
Increased Obligations for Importers and Distributors
MDD: The obligations for importers and distributors were less clearly defined.
MDR: Article 13 and 14 of the MDR explicitly outline the obligations of importers and distributors. These include verifying that devices bear the CE marking, are accompanied by the required information, and that the importer’s details are on the device (for importers). Distributors must also ensure proper storage and transport conditions, inform authorities of non-conformities, and cooperate with corrective actions.
Impact on Distributors: The MDR formalizes and increases the legal responsibilities of distributors. They can no longer simply act as intermediaries but have a clear role in ensuring the compliance and safety of devices they handle. Thorough understanding and implementation of Article 14 obligations are essential.
Greater Transparency and EUDAMED
MDD: Public access to information about medical devices was limited.
MDR: The MDR mandates the establishment of the European Database on Medical Devices (EUDAMED), which will provide a comprehensive and publicly accessible platform for information on medical devices, including registration of devices and economic operators, certificates, clinical investigation data, and vigilance reports.
Impact on Distributors: Distributors will need to register in EUDAMED. The increased transparency will allow stakeholders, including distributors, to access more information about the devices they handle, potentially aiding in due diligence and market understanding.
Stricter Requirements for Materials and Substances
MDD: Requirements regarding hazardous substances were less detailed.
MDR: The MDR introduces stricter requirements concerning the presence of carcinogenic, mutagenic, or toxic to reproduction (CMR) substances and endocrine-disrupting substances in medical devices above a certain concentration limit.
Impact on Distributors: Distributors may need to obtain information from manufacturers regarding the presence of these substances in the devices they distribute and ensure that this information is available as required.
Conclusion
The transition from the MDD to the MDR brings about a more rigorous and comprehensive regulatory framework for medical devices in the EU. For distributors, this means increased responsibilities, a greater focus on traceability and post-market activities, and the need for enhanced collaboration with other economic operators. Understanding these key differences is not just about compliance; it’s about ensuring the safety and performance of medical devices reaching patients and maintaining a sustainable and trustworthy supply chain in the EU market. Distributors must proactively adapt their processes and systems to meet these new requirements to continue operating effectively under the MDR.
FAQ
Q: What is the main difference between MDR and MDD for distributors?
A: The MDR places more explicit and stringent obligations on distributors regarding verification of device compliance, storage and transport, traceability (including UDI), and cooperation in post-market surveillance and vigilance activities compared to the MDD.
Q: How does the MDR’s enhanced traceability affect distributors?
A: Distributors are now required to store and maintain UDI information for the devices they handle, particularly Class III and implantable devices, necessitating changes in their data management and logistics systems.
Q: What is the PRRC, and how does it affect distributors?
A: The Person Responsible for Regulatory Compliance (PRRC) is a new role for manufacturers under the MDR. While distributors generally don’t need one, the presence of a PRRC at the manufacturer level should improve device compliance and may be a point of contact for regulatory matters.
Q: How does the strengthened post-market surveillance under the MDR impact distributors?
A: Distributors have a more formal role in forwarding complaints and information about adverse events to manufacturers and potentially competent authorities, contributing to the overall PMS system.
Q: Will distributors need to register in EUDAMED?
A: Yes, distributors, as economic operators, will be required to register in the European Database on Medical Devices (EUDAMED) once it is fully functional.