MDR Regulation

The European Regulation on Medical Devices

Regulation (EU) 2017/745, known as the MDR – Medical Device Regulation, is the European regulation governing the manufacture, distribution, and monitoring of medical devices.

Fully applicable since May 26, 2021, the regulation has replaced the previous European directives issued in the 1990s, introducing new standards of safety, quality, and traceability for all operators involved in the medical device supply chain.

What is the MDR Regulation

The MDR Regulation sets out the rules that manufacturers, distributors, and industry operators must follow to place compliant medical devices on the European market.

Unlike the previous directives, the regulation is directly binding in all Member States without the need for national transposition, and it aims to:

strengthen the conformity assessment of devices;
ensure greater product traceability through the UDI system;
increase transparency in the responsibilities of economic operators;
enhance the safety of patients and healthcare professionals.

Who Does the MDR Regulation Apply To

The MDR applies to all medical devices and to devices with a non-strictly medical purpose that present similar risks to health.

The regulation involves four main categories of economic operators:

All these parties now share direct responsibilities for the safety and monitoring of the device throughout its entire lifecycle.

What Obligations Does the MDR Regulation Establish

The regulation establishes stricter rules than in the past.
Among the main obligations:

Device classification based on risk and verification of the correct category;
UDI identification system (Unique Device Identification) to ensure traceability of devices placed on the market;
Post-market surveillance (PMS) to monitor safety and performance over time;

Appointment of a PRRC (Person Responsible for Regulatory Compliance), an internal role overseeing device production, compliance, and vigilance;
Registration in the EUDAMED database, to ensure transparency and access to information on devices.

These measures strengthen trust in the European market, protect patients, and improve the overall quality of medical devices.

Traceability and Surveillance Systems: UDI, EUDAMED, PRRC, and PMS

The MDR Regulation is based on four operational pillars that ensure transparency, control, and traceability:

UDI

EUDAMED

PRRC

PMS

UDI

EUDAMED

PRRC

PMS

How Dr. Protec Ensures MDR Compliance

Dr. Protec adopts a rigorous approach to ensure full compliance with Regulation (EU) 2017/745, providing safe, certified, and reliable devices:

verifies the classification and suitability of its devices in accordance with the updated regulation;
maintains a certified quality management system aligned with European standards;
ensures full product traceability through the UDI system;
appoints a qualified PRRC responsible for regulatory oversight and post-market safety;
continuously updates technical documentation and product registration in the EUDAMED database.

MDR Regulation at a Glance

Entry into force: May 25, 2017
Date of application: May 26, 2021
Scope: medical devices and products with a non-medical purpose but similar functions
Main objectives: safety, traceability, transparency, quality
Parties involved: manufacturer, authorized representative, importer, distributor, PRRC
Key tools: UDI, EUDAMED, PMS, surveillance system

The MDR Regulation represents a crucial turning point for the medical device sector, placing greater emphasis on safety, accountability, and traceability.

Dr. Protec is committed to meeting and exceeding these standards on a daily basis, offering certified and compliant products that ensure reliability and protection for professionals and patients.

For more information on current regulations, please contact our Quality Department

MDR Regulation

The European Regulation on Medical Devices

What is the MDR Regulation

Who Does the MDR Regulation Apply To

MANUFACTURER

AUTHORIZED REPRESENTATIVE

IMPORTER

DISTRIBUTOR

What Obligations Does the MDR Regulation Establish

Traceability and Surveillance Systems: UDI, EUDAMED, PRRC, and PMS

How Dr. Protec Ensures MDR Compliance

MDR Regulation at a Glance