EU-MDR
EU-MDR 2017/745: Medical Device Regulation – Requirements, Classification & Conformity
Scope of the Medical Device Regulation (MDR) and Key Terms
Medical Devices, Intended Purpose and Delimitation (MDD/AIMDD/IVDR)
EU MDR 2017/745 is the authoritative regulation for medical devices in the EU and defines comprehensive requirements for manufacturers, products, and their approval. The Medical Device Regulation replaces the previous directives MDD (93/42/EEC) and AIMDD (90/385/EEC) and is clearly delineated from the IVDR for in vitro diagnostic medical devices. The intended purpose, as defined by the manufacturer, is decisive for the categorization as a medical device. This purpose determines the classification, risk class, and the applicable conformity assessment procedure. For medical device manufacturers, this definition is central as it influences all further regulatory steps and ensures the correct categorization of medical devices.
Application Framework in the EU: Products, Companies, Roles of Economic Operators
The MDR, as the European Medical Device Regulation, applies to all companies that provide or place medical devices on the market within the EU. It establishes clear requirements for manufacturers, importers, distributors, and authorized representatives. The regulation defines responsibilities throughout the entire supply chain and obligates all actors to comply with regulatory specifications. The European Commission coordinates the implementation and ensures that medical devices meet legal requirements and that their safety is guaranteed.
Classification according to MDR – Risk Class and Classification Rules
Classes I, IIa, IIb, III: Rules, risk classes and typical examples
The classification of medical devices under the Medical Device Regulation is based on defined classification rules and results in a division into different classes (I, IIa, IIb, III). Each risk class describes the potential risk of a product for the patient and the user. This classification determines the depth of the conformity assessment, the requirements for documentation, and the involvement of notified bodies. Products in higher classes are subject to stricter regulatory requirements and require more extensive evidence regarding the safety and performance of medical devices.
Software as a Medical Device (SaMD) and Accessories – Special Requirements
Software-based medical devices are subject to specific classification rules and are frequently assigned to a higher risk class. The regulatory requirements increase significantly, particularly for diagnostic or therapy-supporting applications. Manufacturers must take aspects such as cybersecurity, data integrity, and functional safety into account, as well as perform a comprehensive risk analysis.
Conformity Assessment & Procedures
Procedures per Risk Class, "Notified Bodies," and Certification
The conformity assessment procedure under the Medical Device Regulation is based on the respective class of a product. While low-risk class products can partially be assessed without external bodies, the involvement of independent “notified bodies” is mandatory for higher risk classes. These bodies verify compliance with all MDR requirements and lead to certification. Successful conformity assessment is a prerequisite for CE marking and thus for market authorization in the European market.
Technical Documentation, Annex I (General Safety and Performance Requirements)
The technical documentation forms the basis of every conformity assessment. It includes all relevant information regarding development, manufacturing, risk, and clinical evaluation. Annex I of the MDR defines the general safety and performance requirements that every product must fulfill. Additionally, Annexes II and III of the Medical Device Regulation are decisive for the structure of the documentation and PMS-relevant content for medical devices.
Laboratory Testing and Evidence Reference (Our Services for MDR Compliance)
Data Collection for the Evaluation of Biological Safety According to the DIN EN ISO 10993 Series of Standards
SAS hagmann supports medical device manufacturers through analytical services in accordance with the 10993 series of standards. Using established and reliable testing procedures, all data required for the toxicological assessment of potential risks that could arise from a medical device is collected. This is a component and a prerequisite of the mandatory technical documentation. SAS hagmann demonstrates that the procedures used are valid and correspond to the recognized state of the art through accreditation by independent bodies.
Clinical Evaluation & Clinical Investigations
Clinical Evidence, PMCF, and MDCG Guidelines
Clinical evaluation is a central element of the MDR and is based on clinical data to assess safety and performance. Manufacturers must continuously collect data as part of the Post-Market Clinical Follow-up (PMCF). The MDCG provides guidelines that support and specify the practical implementation of clinical requirements.
Equivalence, Data Sources, and Risk Management (ISO 14971)
The use of equivalence is only possible to a limited extent and requires detailed evidence. Manufacturers must identify suitable data sources and implement a structured risk management system according to ISO 14971. The goal is the continuous assessment and minimization of risk throughout the entire lifecycle of a product.
UDI, EUDAMED & Labeling
UDI System, Traceability, and Registration in EUDAMED
The MDR mandates the introduction of a Unique Device Identification (UDI) system for medical devices, consisting of the UDI-DI and UDI-PI. This system enables the unique identification and traceability of medical devices. All relevant information must be registered in the European database, EUDAMED, thereby enhancing transparency and market surveillance.
Labeling/IFU, Language, Symbols, and Regulatory Information
The labeling of products must meet all regulatory requirements, including instructions for use (IFU), symbolism, and linguistic requirements. Additionally, information regarding identification, safety, and application is mandatory. For certain classes, a “Summary of Safety and Clinical Performance” (SSCP) must also be provided.
PMS & Vigilance (Post-Market Surveillance)
PMS Plan, PSUR, Trend Reports – Requirements for Manufacturers
Systematic Post-Market Surveillance (PMS) for medical devices is mandatory according to the Medical Device Regulation and involves the continuous monitoring of products after they have been placed on the market. Manufacturers must create a PMS plan and regularly perform reports such as PSUR and trend analyses to ensure long-term safety.
Vigilance Reporting, Incidents, Corrective Actions (FSCA/FSN)
Vigilance includes the systematic recording and reporting of incidents. Manufacturers are obligated to report serious events and implement appropriate corrective actions (FSCA/FSN). These processes are essential for regulatory safety and market surveillance.
Economic Operators & Obligations
Manufacturer/Medical Device Manufacturer, PRRC, Importer, Authorized Representative, Distributor
The MDR, as the Medical Device Regulation, defines clear responsibilities for all economic operators. Every manufacturer must appoint a Person Responsible for Regulatory Compliance (PRRC). Importers and distributors must also ensure that only compliant products are made available on the market.
Quality Management System (QMS) and Responsibilities Along the Supply Chain
An effective quality management system is mandatory and forms the basis for compliance with MDR requirements. It encompasses all processes from development to market surveillance and ensures that regulatory requirements for medical devices are met throughout the entire supply chain.
Transition Periods, Legacy Products & Legacy Devices
MDD/AIMDD Certificates, Extensions, Deadlines, and Evidence Requirements
Special transition periods apply to legacy products. Certificates according to MDD and AIMDD can be extended under certain conditions. However, manufacturers must demonstrate that their products continue to meet current requirements and that there are no increased risks for the medical devices.
Strategy for Transition: Documentation, Resources, Timeline
The transition to the MDR requires structured planning within companies. In addition to updating documentation, resources, timelines, and internal processes must be adapted to ensure timely implementation.
Annexes & Guidelines
Relevant Annexes (e.g., I, II, III, XIV) – Content and Practical Application
The annexes of the MDR contain detailed specifications on safety requirements, documentation, and clinical evaluation. They are essential for the practical implementation of the regulation and serve as the basis for regulatory evidence.
MDCG documents, Commission/Regulation updates, and national interfaces
MDCG guidelines and European Commission publications support manufacturers in interpreting the requirements. National authorities act as interfaces for the practical implementation of the regulation.
