EU MDR Consulting: Medical Device Regulatory Requirements Explained

The EU Medical Device Regulation — Regulation (EU) 2017/745, known as the EU MDR — came into full application on 26 May 2021, replacing the Medical Devices Directive 93/42/EEC (MDD) after a COVID-19 related delay. For medical device manufacturers selling in the EU, the MDR represents the most significant regulatory change in the sector in 30 years. For brands with products on the cosmetic-medical device borderline — a category that includes many skincare, dental, and wellness products — it has created new compliance questions that didn’t exist under the old directive.

What Is the EU MDR?

Regulation (EU) 2017/745 is the EU’s comprehensive regulatory framework for medical devices. It applies to devices intended for human use that are placed on the EU market, including devices manufactured in non-EU countries and imported into the EU.

The MDR significantly strengthened the requirements compared to the MDD it replaced:

• Stricter clinical evidence requirements: Clinical data must be more robust, with higher-quality evidence for higher-risk devices
• Unique Device Identification (UDI): All devices must carry a UDI for traceability
• EUDAMED database: Mandatory registration in the European Database on Medical Devices
• Post-Market Surveillance (PMS): More rigorous ongoing monitoring requirements
• Notified Body oversight: Stricter requirements for Notified Bodies and more intensive audits
• Economic operator obligations: Importers and distributors have explicit obligations under the MDR

What Qualifies as a Medical Device Under EU MDR?

A medical device is defined in Article 2(1) of the MDR as any instrument, apparatus, appliance, software, implant, reagent, material, or other article intended by the manufacturer to be used for one or more specific medical purposes.

The key phrase is “intended by the manufacturer.” The intended purpose — as stated in the labelling, instructions for use, and marketing materials — determines whether a product is a medical device.

This creates a critical compliance issue for borderline products. A moisturiser marketed as “hydrating skin” is a cosmetic. The same moisturiser marketed as “treating eczema” or “managing atopic dermatitis” is a medical device. The formula may be identical — the intended purpose determines the regulatory classification.

Common borderline product categories that may qualify as medical devices:

• Wound care products: Dressings, wound gels, and skin barrier products with wound healing claims
• Dental products: Whitening products with specific dental claims, orthodontic accessories
• Compression garments: Products with specific medical compression claims
• Diagnostic apps and software: Software that analyses health data and provides diagnostic information
• Aesthetic devices: Devices used for aesthetic procedures (e.g., laser devices, radiofrequency devices)

EU MDR Classification: Risk Classes

The MDR classifies medical devices into four risk classes based on their intended purpose and the risks they pose:

Class	Risk Level	Examples	Conformity Assessment
Class I	Low risk	Bandages, non-sterile surgical instruments, corrective glasses	Self-declaration (most Class I)
Class IIa	Medium risk	Hearing aids, dental fillings, blood pressure monitors	Notified Body involvement
Class IIb	Medium-high risk	Infusion pumps, X-ray equipment, surgical lasers	Notified Body involvement
Class III	High risk	Implantable devices, coronary stents, heart valves	Notified Body involvement + clinical investigation

The classification rules are set out in Annex VIII of the MDR and are more complex than the MDD rules. Many devices that were Class I under MDD have been reclassified to Class IIa or higher under the MDR, requiring Notified Body involvement for the first time.

What Is a Notified Body and Why Does It Matter?

A Notified Body is an independent conformity assessment organisation designated by an EU member state to assess the conformity of certain medical devices with the MDR requirements. Notified Bodies are designated by national authorities (in France, by ANSM) and listed in the NANDO (New Approach Notified and Designated Organisations) database.

For Class IIa, IIb, and III devices, the manufacturer must engage a Notified Body to assess their quality management system and technical documentation before CE marking the device. The Notified Body issues a CE certificate, which is required for market access.

The MDR significantly increased the requirements for Notified Bodies, and many Notified Bodies that were designated under the MDD lost their designation or reduced their scope under the MDR. This created a significant bottleneck: demand for Notified Body services increased (due to reclassification of many devices) while the number of available Notified Bodies decreased.

As of 2026, there are approximately 40 Notified Bodies designated under the EU MDR, compared to over 80 under the MDD. Wait times for Notified Body assessment can be 12 to 24 months for new applications.

What Do Manufacturers Need to Do for EU MDR Compliance?

Technical Documentation

Every medical device must have Technical Documentation demonstrating conformity with the MDR’s General Safety and Performance Requirements (GSPRs) in Annex I. The Technical Documentation includes:

• Device description and specification
• Design and manufacturing information
• General safety and performance requirements (GSPR) checklist
• Benefit-risk analysis
• Product verification and validation data
• Clinical evaluation report (CER)
• Post-market surveillance plan

Clinical Evaluation

The MDR requires a clinical evaluation for all devices, regardless of risk class. The clinical evaluation must be based on clinical data — either clinical investigation data, published literature, or equivalent device data — and must demonstrate that the device achieves its intended purpose, that the benefits outweigh the risks, and that the device performs as claimed.

The MDR’s clinical evidence requirements are significantly stricter than the MDD. For Class III and implantable devices, clinical investigations are typically required. For lower-risk devices, literature-based clinical evaluations may be sufficient, but the quality of evidence required has increased.

Quality Management System

Manufacturers must implement a Quality Management System (QMS) compliant with the MDR. ISO 13485:2016 is the recognised standard for medical device QMS and is the baseline expectation for MDR compliance. The QMS must cover design and development, production, post-market surveillance, and complaint handling.

EUDAMED Registration

All medical devices placed on the EU market must be registered in EUDAMED (European Database on Medical Devices). EUDAMED registration is mandatory and must be completed before CE marking. The EUDAMED system is being phased in — full mandatory use of all EUDAMED modules is expected by 2026.

Unique Device Identification (UDI)

All devices must carry a UDI — a unique numeric or alphanumeric code assigned to a device model. The UDI must appear on the device label and packaging, and must be registered in EUDAMED. Implementation timelines vary by device class.

The Transition Timeline

The MDR transition has been challenging. Many manufacturers who held MDD CE certificates were unable to renew them under the MDR due to Notified Body capacity constraints. The EU Commission has extended transition periods multiple times:

• Class III and Class IIb implantable devices: MDD certificates valid until 31 December 2027 (subject to conditions)
• Class IIa, Class IIb non-implantable, and Class I sterile/measuring devices: MDD certificates valid until 31 December 2028 (subject to conditions)

These extensions apply only to devices that were already CE marked under the MDD and where the manufacturer has applied for MDR certification. New devices entering the market must comply with the MDR from day one.

EU MDR Consulting: What Does It Involve?

EU MDR consulting typically covers:

• Gap assessment: Comparing current technical documentation and QMS against MDR requirements
• Classification review: Confirming the correct risk class under MDR rules (many devices changed class from MDD to MDR)
• Notified Body strategy: Selecting an appropriate Notified Body, preparing the application, and managing the assessment process
• Clinical evaluation: Developing the clinical evaluation strategy and preparing the Clinical Evaluation Report (CER)
• Technical documentation preparation: Writing or reviewing technical documentation against MDR Annex II/III requirements
• EUDAMED registration: Completing device and manufacturer registration in EUDAMED

At Care Europe, we support medical device manufacturers — particularly those in the borderline product space between cosmetics and medical devices — with MDR compliance strategy and documentation preparation. Contact us at [email protected].