EU MDR Establishes Comprehensive Framework for Medical Devices in the European Union

Regulation (EU) 2017/745 of the European Parliament and of the Council establishes the European regulatory framework for medical devices.

The Regulation applies to the placing on the market, making available on the market and putting into service of medical devices for human use and their accessories in the European Union. It also applies to clinical investigations concerning those devices and accessories.

The MDR was introduced to create a more robust, transparent, predictable and sustainable regulatory framework for medical devices, while supporting a high level of health and safety protection.

Strengthened Regulatory Requirements

The Regulation reinforces key areas of the medical device framework, including:

• notified body supervision;

• conformity assessment procedures;

• clinical investigations;

• clinical evaluation;

• vigilance;

• market surveillance;

• transparency;

• device traceability.

The MDR also clarifies the responsibilities of economic operators, including manufacturers, authorised representatives, importers and distributors.

Scope and Definitions

The Regulation defines a medical device as an instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used for specific medical purposes in human beings.

It also includes definitions for accessories, custom-made devices, active devices, implantable devices, invasive devices, single-use devices, intended purpose, UDI, clinical evaluation, clinical data, post-market surveillance, serious incidents and field safety corrective actions.

The Regulation excludes certain products from its scope, including in vitro diagnostic medical devices covered by Regulation (EU) 2017/746, medicinal products, advanced therapy medicinal products, cosmetics and certain products containing viable biological material.

Market Access and CE Marking

Under the MDR, devices may only be placed on the market or put into service if they comply with the Regulation when properly supplied, installed, maintained and used according to their intended purpose.

Devices must meet the applicable General Safety and Performance Requirements set out in Annex I.

As a general rule, devices must bear the CE marking to indicate conformity with the MDR and to benefit from free movement within the Union.

Obligations of Manufacturers and Economic Operators

The MDR sets out detailed obligations for manufacturers.

Manufacturers must ensure that devices are designed and manufactured in accordance with the Regulation. They must also establish and maintain a risk management system, perform clinical evaluation, prepare technical documentation, implement a quality management system, apply post-market surveillance and meet vigilance reporting obligations.

The Regulation also includes obligations for authorised representatives, importers and distributors, including checks related to CE marking, EU declarations of conformity, labelling, UDI and cooperation with competent authorities.

Clinical Evaluation, PMS and Vigilance

The MDR places strong emphasis on clinical evidence throughout the device lifecycle.

Manufacturers must perform clinical evaluation and, where applicable, post-market clinical follow-up. They must also establish a post-market surveillance system to proactively collect and analyse experience gained from devices placed on the market.

The Regulation also strengthens vigilance requirements, including the reporting of serious incidents and field safety corrective actions.

Transparency, UDI and EUDAMED

The MDR introduces a system for Unique Device Identification, intended to improve traceability, incident reporting, field safety corrective actions and market surveillance.

The Regulation also provides for the development of EUDAMED, the European database on medical devices, designed to improve transparency and facilitate information exchange between economic operators, notified bodies, competent authorities, Member States and the European Commission.

Impact on Medical Device Manufacturers

For medical device manufacturers, the MDR represents a comprehensive regulatory framework affecting the full product lifecycle.

Manufacturers should pay particular attention to:

• device qualification and classification;

• applicable General Safety and Performance Requirements;

• technical documentation;

• clinical evaluation and clinical evidence;

• quality management systems;

• risk management;

• CE marking and conformity assessment;

• notified body involvement where required;

• UDI and registration obligations;

• post-market surveillance and PMCF;

• vigilance reporting;

• responsibilities of authorised representatives, importers and distributors.

For manufacturers placing medical devices on the EU market, the MDR reinforces the need for a structured, lifecycle-based approach to regulatory compliance, from device design and clinical evidence through to post-market monitoring and vigilance.