EU MDR Compliance: A Complete Guide

Understanding and Complying with the EU Medical Device Regulation

The European Union (EU) Medical Device Regulation (MDR) (2017/745) is a regulatory framework that governs the production and distribution of medical devices in the EU. It holds medical device manufacturers to strict safety standards regarding the use of harmful substances in their devices. The regulation replaced the EU Medical Devices Directive (MDD) (93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD) (90/385/EEC).

Enacted in May 2021, the MDR is still in its implementation phase with various deadlines for distinct types of devices. It's critical for manufacturers and distributors of medical devices to understand the regulation, how their devices are classified, and how to achieve compliance before the MDD and AIMDD are phased out and the MDR is fully enforced.

This e-book explains the fundamentals of the EU Medical Device Regulation (MDR), detailing its stringent safety standards and reporting requirements. It breaks down the classification of medical devices under the MDR so manufacturers can accurately determine their regulatory pathway. Next, the guide outlines key steps and best practices for achieving EU MDR product compliance. Finally, it demonstrates how Source Intelligence’s EU MDR solution streamlines the compliance process, reducing risk and administrative burdens while ensuring your products meet evolving regulatory standards.

Understanding the European Union Medical Device Regulation

What is the EU Medical Device Regulation?

The European Union (EU) Medical Device Regulation (MDR) (2017/745) is a regulatory framework that governs the production and distribution of medical devices in the EU. It was adopted in 2017 and implemented on May 26, 2021, replacing the EU Medical Devices Directive (MDD) (93/42/EEC) and the Active Implantable Medical Devices Directive (AIMDD) (90/385/EEC). It intends to ensure that medical devices in the EU meet strict safety and quality standards, while supporting fair market access. 

The regulation restricts the use of certain hazardous substances in the design and manufacturing of medical devices and establishes reporting requirements for devices containing any restricted substances over a certain threshold. Medical device companies (i.e., legal manufacturers) that intend to sell or distribute their products within the EU member states must comply.

Which substances are restricted by the EU MDR? 

Under the EU MDR, medical devices cannot contain carcinogenic, mutagenic, toxic for reproduction, or endocrine-disrupting substances over the 0.1% (weight by weight) threshold without justification. 

The definitions and reporting requirements for reportable substances under the MDR are consistent with the EU Classification, Labeling, and Packaging (CLP) regulation (1272/2008) and the EU Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation (1907/2006). This means device manufacturers can review their suppliers’ EU product safety data sheets (SDS) for data on any reportable components.

What are the implementation timelines for the EU MDR? 

Since the EU MDR is a relatively new regulation, there are implementation timelines for various device classifications. Devices previously determined to comply with the repealed directives (MDD and AIMDD) and issued compliance certificates are recognized as valid for the implementation period. This allows manufacturers to continue placing their devices on the market while transitioning to the MDR's reporting requirements. 

• May 26, 2026 – Class III custom-made implantable devices. 
• December 31, 2027 – Class III devices covered by valid MDD/AIMDD certificates as of 3/20/2023 or Class IIb implantable devices (excluding well-established technologies (WET) under MDR, such as sutures, dental fillings, and screws). 
• December 31, 2028 – Devices covered by valid MDD/AIMDD certificates as of 3/20/2023, including Class IIb (excluding Class IIb implantable non-WET), Class IIa, Class I sterile devices, or Class I devices with a measuring function. This timeline also applies to devices that did not require notified body certification under the MDD, but now require it under the MDR.

Although the final deadlines for transitioning to MDR compliance are a few years into the future, manufacturers and distributors of medical devices are strongly encouraged to take advantage of the time and submit their MDR applications as soon as possible to reduce the risk of disruptions. 

What is the difference between the EU MDR and IVDR? 

When the EU MDR was enacted in 2021, it was accompanied by a complementary regulation, the In Vitro Diagnostic Medical Devices Regulation (IVDR) (2017/746). EU IVDR is similar to the EU MDR, but it is a separate regulation with several crucial differences: 

The IVDR covers in vitro devices only, and excludes any medical devices covered under the MDR. 

While the IVDR identifies the same harmful chemicals restricted under MDR, it does not restrict them. 

Compliance with the IVDR does not require chemical reporting, but device data is encouraged to be collected and used to support a company’s internal product compliance due diligence efforts.

Classification of medical devices under EU MDR 

The EU MDR’s classification system is based on the level of risk posed to patient safety by the medical device. Here is a simple breakdown of the classification system: 

• All medical devices under EU MDR are divided into four classes: I, IIa, IIb, and III. 
• Of the four classes, Class I devices, which pose the lowest risk to safety, are further separated into four sub-classes: Class I, Class Is, Class Im, and Class Ir. 
• Each class covers devices in four categories: non-invasive devices, invasive devices, active devices, and devices with special rules. 
• Each device category has its own classification rules to determine which class the device falls under. 

Device Classes

The device classes under EU MDR, their risk level, and examples of devices that fall within them are listed below. 

Class I – Low-risk devices, such as bandages, glasses, and stethoscopes 

• Class I – Non-sterile devices or products without a measurement function, like gauze or gel 
• Class Is – Sterile product that must be transported in a sterile condition or sterilized on receipt, like a gown or a syringe 
• Class Im – Devices with a measuring function, like syringes or spoons for administering medications 
• Class Ir – Products that have been reprocessed or reused, like dental and surgical instruments 
• Class IIa – Medium-risk devices, such as hearing aids, surgical clamps, and catheters 
• Class IIb – Medium- to high-risk devices, such as ventilators, insulin pens, and long-term contact lenses 
• Class III – High-risk devices, such as pacemakers, prosthetic heart valves, and surgical mesh 

Discover more about EU MDR compliance

You’ve just explored the fundamentals of the EU Medical Device Regulation and reviewed the various device classes that determine risk levels. Next, the e-book delves into achieving EU MDR product compliance, outlines practical steps for meeting stringent reporting requirements, and demonstrates how Source Intelligence’s EU MDR solution streamlines the entire process and mitigates risk.

Read the full e-book to secure your path to compliance and safeguard your market access.