What is MDR?

The Medical Device Regulation (EU) 2017/745 (MDR) is a European legal framework that governs all medical devices placed on the EU market. It replaces the former Directives 93/42/EEC (MDD) and 90/385/EEC on active implantable devices. Fully applicable since May 26, 2021, MDR affects all manufacturers, importers, and authorised representatives operating within the EU. It also applies to certain products without an intended medical purpose, as listed in Annex XVI.

MDR vs MDD – Key Differences

Compared to the previous MDD, MDR introduces stricter, more detailed and legally binding requirements. Key changes include:

expanded scope of covered products,
mandatory clinical evaluation for all device classes,
introduction of PRRC (Person Responsible for Regulatory Compliance),
reporting obligations in EUDAMED,
UDI implementation for every CE-marked product,
stricter oversight from notified bodies and mandatory PMS and vigilance systems.

Scope of MDR

MDR applies to all medical devices, including custom-made, implantable, sterile, active and reusable surgical instruments. It also covers procedure packs, system kits and non-medical aesthetic products (e.g., cosmetic lasers, colored contact lenses). The regulation explicitly includes software that performs a medical function – known as Software as a Medical Device (SaMD).

Objectives and Significance of MDR

The core goal of MDR is to enhance patient safety and ensure regulatory transparency in the medical device sector. The regulation seeks to guarantee that only safe, effective and well-documented products are marketed in the EU. It mandates:

uniform risk classification rules,
Post-Market Surveillance (PMS),
incident reporting through the vigilance system,
public access to certification and clinical study data via EUDAMED.

Risk Classification of Medical Devices under MDR

MDR introduces four risk-based classes of medical devices, as outlined in Annex VIII:

Class I – low risk,
Class IIa – medium risk,
Class IIb – high risk,
Class III – highest risk (e.g., implants, life-support devices).

The classification determines the conformity assessment route, scope of documentation, and whether a notified body is required.

Certification Procedure under MDR

The MDR certification process includes:

preparing the technical documentation,
conducting a clinical evaluation,
implementing risk management,
conformity assessment by a notified body (for classes above I),
issuing the Declaration of Conformity and affixing the CE mark.

Role of EUDAMED

EUDAMED is the EU’s centralized medical device database. It stores and shares data on device registrations, certificates, notified bodies, clinical investigations and safety reports. Manufacturers, authorised representatives and importers are all required to submit data. EUDAMED consists of six modules, including UDI, vigilance, clinical studies and market surveillance.

PRRC Requirement

According to Article 15 of MDR, every EU-based manufacturer must appoint a Person Responsible for Regulatory Compliance (PRRC). This individual ensures the conformity of technical documentation, manages PMS and vigilance, and oversees regulatory registration duties.

EU Authorised Representative

The Authorised Representative is mandatory for non-EU manufacturers under MDR 2017/745. Without appointing an Authorised Representative, no medical device can be lawfully placed on the EU market. The AR represents the manufacturer before regulatory authorities.

UDI System

UDI (Unique Device Identification) is a unique numeric or alphanumeric code assigned to a medical device. It consists of a device identifier and production identifier. UDI improves traceability, supports recall procedures and enhances post-market monitoring. Each CE-marked product must have an assigned UDI and be registered in EUDAMED.

Technical Documentation Requirements

Technical documentation under MDR must include:

design, function and intended use,
material and manufacturing specifications,
preclinical and clinical evidence,
PMS and vigilance records,
comprehensive risk analysis and validation protocols.

Manufacturer Obligations under MDR

Manufacturers of medical devices must:

keep clinical evaluations up to date,
maintain PMS systems and report adverse events,
complete EUDAMED registration,
cooperate with a notified body based on device class,
manage the full lifecycle of the product.

MDR Implementation Timeline

MDR has been fully applicable since May 26, 2021. However, transitional periods have been extended via Regulation (EU) 2023/607:

until May 26, 2026 – for custom-made Class III devices,
until December 31, 2027 – for high-risk Class IIb and III implants,
until December 31, 2028 – for other lower-risk devices.

Regulation (EU) 2024/1860 introduced further updates on EUDAMED and registration workflows. Manufacturers are expected to follow MDCG guidance and adapt internal systems accordingly.

How Pure Clinical Can Help You Comply with MDR

Pure Clinical offers end-to-end support for MDR compliance, including:

preparation and auditing of technical documentation,
device classification and conformity route strategy,
review of clinical data and PMS strategy,
guidance on EUDAMED, PRRC, UDI, and notified body interaction.

We support manufacturers of traditional devices as well as digital solutions (SaMD), implants and high-risk technologies. All services are fully aligned with MDR, IVDR, ISO 13485 and MDCG guidance.

FAQ

Does MDR apply to devices used exclusively in clinical investigations?

Yes. MDR applies to devices used in clinical investigations when the purpose is to support CE marking or collect safety and performance data for conformity assessment.

What happens to devices certified under MDD after the transition period?

Devices with valid MDD certificates may remain on the market during the transition, provided no significant changes are made. After that, MDR certification is mandatory.

When is EUDAMED registration mandatory for manufacturers?

Full EUDAMED registration will become mandatory once all modules are functional. Until then, voluntary registration is encouraged to prepare internal systems and UDI data.

What qualifications are required for a PRRC under MDR?

A PRRC must hold a degree in law, medicine, pharmacy, engineering, or a related field, plus one year of regulatory or quality management experience in medical devices.

Is all software considered a medical device under MDR?

No. Only software with a medical purpose—such as diagnosis, monitoring, or treatment—is subject to MDR. General wellness or lifestyle apps are excluded.

Medical Device Certification Guide – MDR 2017/745