All medical devices to be placed on the EU Market need to get a CE Mark. The latest EU Medical Device Regulations have significantly impacted the compliance process. Medical device consultant Sophie Laurenson, Ph.D., outlines the major changes in the EU MDR and the consequence of these changes.
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In recent years, several high-profile incidents have highlighted the weaknesses in the Medical Device Directives (MDD) active in the European Union (EU). The Medical Device Regulation (MDR) was introduced to address these weaknesses and improve the performance and safety of medical devices in Europe. The new regulations (fully titled REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices) were approved by the European Parliament on the 5th April 2017 and published in the Official Journal of the European Union on 5th May 2017.
The MDR represents a significant shift in approach to regulating medical devices, in response to changes in the scientific and technical landscape shaping the medical device industry. The implementation of the regulation is staged over a three-year transition period, to enable manufacturers to adjust. To ensure market access within the EU, all medical device products must achieve a CE Mark under the new regulation 2017/745. This obligation affects existing on-market products as well as products that are currently in development.
The changes introduced in the MDR affect many aspects of the CE-Marking process including device classification, Technical File documentation, Post-Market Activities as well as business partners of device manufacturers. The overarching aim of the new regulations is to enable “…a fundamental revision of those Directives is needed to establish a robust, transparent, predictable and sustainable regulatory framework for medical devices which ensures a high level of safety and health whilst supporting innovation.” (MDR 2017/745, 1).
Medical device classification stratifies products according to risk and specifies the conformity assessment routes required for CE Marking. While the overall classification scheme from Class I to Class III has been retained in the MDR regulation, some products have been reclassified. The MDR Classification rules are outlined in Annex VIII. In particular, the requirements for some digital and software products have been delineated in Classification Rule 11. Reformed obligations also apply to reusable Class 1 devices, cosmetic implants and products without an intentional medical function (described in MDR Annex XVI). Manufacturers will need to accurately classify their products and determine whether new conformity assessment routes are required. This represents a challenge in cases where devices are reclassified in a higher risk profile group, requiring clinical and technical data that may not be readily available.
The MDR regulation affects both manufacturers and their business partners, including Economic Operators within the product supply chain. This includes product Importers and Distributors, which are explicitly regulated under MDR Article 25 (in addition to Articles 13 and 14). There are also more prescriptive requirements placed on EU Authorized Representatives (EUAR) as described in MDR Article 11. EUAR partners must be registered, have appropriate regulatory systems, personnel and liability insurance in place. MDR Article 15 describes the requirement for a Person Responsible for Regulatory Compliance (PRRC) to be appointed for manufacturers and EUAR organizations. This individual must have either appropriate academic qualifications in a relevant scientific discipline and at least one year of professional experience; or alternatively, four years of professional experience. Micro and small enterprises are excluded from requiring a permanent PRRC position but must have a suitable candidate continuously at their disposal.
The Technical File (or Design Dossier) is an important component of medical device regulation. This documentation should include a comprehensive description of the device and demonstrate regulatory compliance. A Technical File contains detailed information on the function, design, intended use, clinical evaluation and claims surrounding a medical device. The MDR specifies a significant revision of the current approach to Technical File generation. To harmonize the technical documentation required by global regulators, requirements have been based on the current GHTF (Global Harmonization Task Force) STED guidance document.
Essential Requirements (ERs) in the MDD have been replaced by Safety and Performance Requirements (MDR Annex I). Manufacturers will need to identify the applicable requirements and ensure compliance through technical and clinical data and risk management. For devices that are in conformity with relevant harmonized standards, the Presumption of Conformity remains (outlined in MDR Article 8). However, in instances where harmonized standards do not exist or are insufficient, the European Commission may define Common Specifications.
Clinical Evaluation Reports
Clinical Evaluation Reports (CERs) document the clinical data pertaining to a medical device. Recent revisions to the MDD placed greater emphasis on clinical investigations in the CER. The MDR is more explicit regarding the need for clinical evidence and evaluation (MDR Annex XIV, Part A). The criteria for establishing equivalence will become more stringent and the use of scientific literature in clinical evaluations will become strictly regulated. This may require manufacturers to alter their CER processes and obtain additional data from clinical investigations. It is also anticipated that there will be enhanced scrutiny of CERs by Notified Bodies (NBs). Manufacturers should review the CERs in their legacy and development portfolios and ensure that they conform to new specifications. This is particularly important in cases where the initial CE Marking was supported with limited clinical data and Post-Market Surveillance activities have generated additional data. For devices with high risk profiles (such as Class III or implantable devices), a Summary of Safety and Clinical Performance must be compiled and deposited on the EUDAMED database (see below) (MDR Article 32).
Post Market Surveillance (PMS) and Vigilance
Requirements for PMS and Vigilance activities are expected to change significantly under the new MDR. Device manufacturers are required to collect Post Market Clinical Follow up (PMCF) data to assess potential safety risks. This process continues throughout the lifecycle of a product and contributes to continuous clinical evaluation (MDR Annex XIV, Part B). Periodic Safety Update Reports (PSUR) will be required, although the frequency is dependent on device type (MDR Article 86). Electronic vigilance reporting will be introduced (MDR Article 92) and reporting timeframes are reduced for serious incidents (MDR Article 87).
Traceability and Transparency
Transparency is one of the key areas that the MDR is seeking to improve: “transparency and adequate access to information, appropriately presented for the intended user, are essential in the public interest, to protect public health, to empower patients and healthcare professionals and to enable them to make informed decisions, to provide a sound basis for regulatory decision-making and to build confidence in the regulatory system’’. MDR Article 33 contains a provision for a European Data Bank on Medical Devices (EUDAMED) containing data provided by manufacturers on registered devices and economic operators, clinical investigations and post-market activities. NBs will also provide information and certificates on this system. In some instances, this data will be available to the public. The EUDAMED system is an ongoing project, managed by the European Commission and manufacturers should closely follow the development of the project to ensure compliance.
Unique Device Identification system (UDI) System
The MDR mandates the identification and traceability of all devices marketed within the EU through a Unique Device Identification system (UDI System) (MDR Articles 27 – 29 and MDR Annex VI). The UDI system is recommended based on international guidance and aims to improve post-market safety related activities. Under these regulations, each device must be assigned an UDI and the data stored in the EUDAMED database. UDIs will be provided by an approved supplier, prior to the launch of the product, and the UDI carrier must be specified on the device or its packaging. The exact specifications of the proposed EU UDI system have yet to be confirmed, but it is expected to mirror the newly established U.S.A system. Consequently, these requirements will not be mandatory at the end of the transition period but will come into force in early 2021 for devices with high risk profiles. Devices with lower risk profiles will be gradually phased in over subsequent years.
The MDR regulations also stipulate some changes surrounding product labelling and precautionary statements for products. In addition to data located on packaging, relevant information should also be made available and regularly updated on the manufacturer’s website. These requirements apply to specific details for labels and for sterile packages (MDR Annex I), inclusion of information for vulnerable patient groups, precautionary measures and information on Hazardous Substances.
Single Use Devices and their Reprocessing
The reprocessing of single-use devices will only be permitted in settings where permitted by National law, with overarching requirements specified in MDR Article 17. Under these regulations, any entity which reprocesses a single-use device is considered a manufacturer and must ensure an equivalent level of safety and performance compared to the initial single-use device. Affected organizations should check that reprocessing is permitted in their National Law and ensure that the resulting obligations are met. This may involve implementing processes, training personnel and mobilizing resources which were previously unnecessary.
The MDR is expected to result in significant change in the CE-Marking process for medical devices in Europe. The changes are extensive and may require organizations to take a comprehensive and structured approach to preparing for the full implementation of the MDR. Many of the changes affect several functions within a manufacturer organization as well as their business partners and NBs. Some changes broadly affect organizations, such as more detailed requirements for Quality Management Systems (QMS) (MDR Annex IX) or the requirement for insurance providing sufficient financial coverage for any potential liability. Coordination between stakeholders within and between organizations will help to smooth the transition between regulatory phases.
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