European Medical Device Regulation (EU MDR)

What Is the EU Medical Device Regulation (MDR)?

Effective May 26, 2021

The EU Medical Device Regulation (Regulation (EU) 2017/745, the MDR) governs how medical devices reach and stay on the European market. It has applied since May 26, 2021, and it replaced the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC). It's biggest changes included the lifecycle approach and requirements for reporting, documentation, product-specific quality and risk management systems.

The MDR applies across the European Economic Area. It sets duties for manufacturers first, and also reaches importers, authorized representatives and distributors.

Full Text: EU Medical Device Regulation

EU MDR Compliance Requirements

For Manufacturers, Importers, Distributors and Representatives

Device Definition

Is your product a medical device?

EU Medical Device Definition

The EU MDR's definition is broad. It covers "any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more" specific medical purposes.

A medical purpose means one of the following: detecting, preventing, monitoring or predicting disease; treating or relieving disease, injury or disability, or compensating for an injury; examining or altering the body's anatomy or a physiological process; or producing diagnostic information from samples taken from the body. To stay a device rather than a medicine, the product must work mainly through physical or structural means rather than by pharmacological, immunological or metabolic action, though such means may support how it works. The MDR also covers devices for the control or support of conception, and products intended to clean, disinfect or sterilize other devices.

As a general guide, a product that tests a sample taken from the body to give a diagnostic result falls under the separate In Vitro Diagnostic Regulation (IVDR, Regulation (EU) 2017/746). Most other products that meet a medical purpose fall under the MDR.

Read the full definition in Article 2

EU MDR Requirements

What the EU MDR Requires

The MDR builds safety evidence across a device's whole life, not only before launch.

A manufacturer must:

Classify the device by risk and confirm the conformity route
Run a quality management system and a risk management system specific to the device
Conduct a clinical evaluation
Compile technical documentation that proves the device meets the general safety and performance requirements
Label the device and write its instructions for use
Affix the CE mark and register the device and itself in EUDAMED
Monitor the device after launch through post-market surveillance and vigilance reporting
Appoint an EU authorized representative if the manufacturer is based outside the EU, to act on its behalf and hold its technical documentation

Higher-risk devices, and certain Class I devices that are sterile, have a measuring function or are reusable surgical instruments, also require a notified body to assess conformity.

These duties sit mainly with the manufacturer, but the MDR spreads obligations across the supply chain. Importers and distributors must verify that a device carries the CE mark and required documentation before they place it on the market or pass it on, and they must keep records that support traceability.

Example Requirements by Device Class

Biological Safety & ISO 10993-1

Biocompatibility Requirements for the EU MDR

Biological safety is central to MDR evidence.

Devices that contact the body must demonstrate biological safety. ISO 10993-1 is the standard for that evaluation.

The 2025 edition aligns biological evaluation with ISO 14971 risk management. It requires stronger chemical and toxicological evidence to support, and in some cases reduce, biological testing.

Hohenstein builds this evidence through biocompatibility testing and consulting, chemical characterization and E&L analysis and toxicological risk assessment that connects a device's chemistry to patient exposure limits.

EUDAMED Registration

EUDAMED - The EU Medical Device Database

Registration is mandatory as of May 28, 2026.

EUDAMED is the EU database for medical devices and in vitro diagnostics. Until it became mandatory on May 28, 2026, manufacturers used it voluntarily. Now, the four core modules are mandatory under the MDR and IVDR.

Now, manufacturers, importers, authorized representatives and notified bodies must meet EUDAMED registration and transparency obligations. Manufacturers should register in the Actor module and prepare device data before placing a device on the EU market.

Device Classifications

How are medical devices classified under the MDR?

The MDR divides devices into four risk classes: Class I, Class IIa, Class IIb and Class III.

Classification depends on the device's intended purpose, how long it contacts the body, how invasive it is and whether it is active (per Annex VIII).

Class I - lowest risk (e.g. non-powered wheelchairs, tongue depressors, stethoscopes, examination gloves, corrective eyeglasses, reusable surgical instruments, non-invasive thermometers)
Class IIa - moderate to higher risk (e.g. hearing aids, catheters, surgical gloves, dental fillings, suction equipment, ultrasonic diagnostic equipment, short-term wound dressings, blood transfusion sets)
Class IIb - moderate to higher risk (e.g. ventilators, infusion pumps, dialysis machines, anesthesia equipment, bone fixation plates, X-ray machines, surgical lasers, condoms, long-term wound dressings)
Class III - highest risk - (e.g. pacemakers, implantable defibrillators, heart valves, coronary stents, spinal implants, absorbable sutures, breast implants, devices incorporating a medicinal substance)

The same kind of device can fall in different classes, depending on how it is used. For example:

Wound dressings - class IIa for short-term use, Class IIb when used long-term or to manage a breached skin barrier
Catheters - class depends on where the catheter goes and how long it stays, ranging across IIa, IIb and III
Suction equipment - class varies with intended use and how it connects to other devices
Medical software - classed by what it does, not what it is, from Class I up to Class III
Spinal implants - class depends on the implant type and where it sits
Absorbable sutures - class depends on whether and how the material is absorbed by the body

Higher classes require more notified body involvement and more clinical and safety evidence.

Example Requirements by Device Class

Upcoming Changes

What is changing under the proposed revision?

December 2025 Proposal

The European Commission has proposed a revision of the MDR and IVDR to simplify the rules and reduce administrative burden. The proposal is not law. Public consultation runs into 2026, and changes are not expected to take effect before the end of 2026.

If adopted as proposed, the revision would, among other things:

Replace the five-year cap on certificate validity with periodic risk-based reviews by notified bodies
Lower the risk class of some devices, removing the notified body step for them
Allow more flexibility in using clinical data from equivalent devices and non-clinical data
Introduce criteria and faster review for breakthrough and orphan devices

These changes would adjust timelines and review steps. They would not remove the core safety evidence a device needs, including biocompatibility, chemical characterization and toxicological risk assessment.

Hohenstein Medical is a division of Hohenstein Laboratories, an independent testing and research partner defined by scientific expertise, integrity-focused practices and rigorous quality standards across diverse technical fields.

How Hohenstein Medical Supports MDR Compliance

Hohenstein Medical is an ISO/IEC 17025 accredited and GLP-certified for medical device testing, with results recognized by the FDA, the EU and regulatory bodies worldwide. We test across chemical, physical and biological disciplines and develop custom protocols where standard methods fall short. Results are documented for direct use in your technical file, risk evaluation and clinical assessment.

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FAQ

Does a non-EU manufacturer need an EU authorized representative?

Yes. A manufacturer based outside the EU must appoint an authorized representative established in the EU. The representative acts on the manufacturer's behalf and holds the technical documentation.

When does EUDAMED become mandatory?

Use of four core EUDAMED modules became mandatory on May 28, 2026, under the MDR and IVDR. Until then, manufacturers used the database voluntarily.

Does Breakthrough or simplified review remove biocompatibility testing?

No. Faster review paths can shorten timelines, but they do not waive the biological safety evidence a device needs, including biocompatibility, chemical characterization and toxicological risk assessment.

What is an active medical device?

An active medical device runs on a power source other than the body or gravity, and it works by changing or converting that energy. Examples include infusion pumps, ventilators and X-ray units. Medical software is also classed as an active device.

A device that only transmits energy or a substance between an active device and the patient, without significantly changing it, is not active on its own.

Whether a device is active is one of the risk classification factors under the MDR.

What is the difference between the old EU MDD and the EU MDR?

The MDR changed the scope of the medical device legislation and extended its application to all economic operators in the supply chain (manufacturers, authorized representatives, importers and distributors).

The MDR emphasizes a lifecycle-based safety approach - to be supported by clinical data and new requirements such as transparency and traceability
The manufacturer must establish and prove quality management and risk management systems specific to the product and conduct a clinical evaluation
Reports must include all undesirable effects, defects and malfunctions, not just life-threatening incidents
Stricter requirements for reprocessing
Evidence of comprehensive clinical evaluations

Example Requirements by Class

Duties accumulate as risk rises.

EU Requirements for a Class I Medical Device

A Class I manufacturer must:

Confirm the product meets the definition of a medical device and classify it as Class I
Meet the general safety and performance requirements
Conduct a clinical evaluation
Compile technical documentation
Notified body involvement is required only for Class I sterile devices, devices with a measuring function and reusable surgical instruments.
Prepare labeling and instructions for use
Affix the CE mark
Register the device and the manufacturer in EUDAMED
Establish post-market surveillance, including data review, vigilance reporting and handling of non-compliant products

EU Requirements for a Class II Medical Device

A Class II manufacturer must fulfill Class I duties with these changes:

Classify the device as Class IIa or Class IIb
Meet the general safety and performance requirements
Conduct a clinical evaluation
Class IIa can often rely on equivalence and literature; Class IIb is expected to carry more device-specific clinical data.
Involve a notified body in conformity assessment
For Class IIa, the notified body samples technical documentation across device categories; for Class IIb it reviews the technical documentation for each device type, a deeper assessment.
Prepare labeling and instructions for use
Affix the CE mark with the notified body's identification number
Register the device and the manufacturer in EUDAMED
Establish post-market surveillance, including a periodic safety update report, vigilance reporting and handling of non-compliant products

EU Requirements for a Class III Medical Device

A Class II manufacturer must fulfill Class II duties, plus:

Classify the device as Class III
Support the clinical evaluation with clinical investigation data
Undergo notified body assessment of the quality management system and the technical documentation for the device
For implantable and certain Class III devices, complete the clinical evaluation consultation procedure, an additional expert panel review
Produce a Summary of Safety and Clinical Performance, a public document required for implantable and Class III devices
Hold a valid notified body certificate before placing the device on the market and keep it under ongoing notified body surveillance
Run post-market surveillance with a periodic safety update report and, where required, post-market clinical follow-up

Testing for the EU Medical Device Regulation (EU MDR)