CE marking a medical device under Regulation (EU) 2017/745 requires considerably more than demonstrating that a product performs as intended. Manufacturers must establish the device’s intended purpose, determine its regulatory classification, manage risks throughout its lifecycle, generate appropriate clinical evidence, demonstrate conformity with the applicable General Safety and Performance Requirements and maintain post-market controls after market entry.
Regulation (EU) 2017/745, commonly known as the Medical Device Regulation or MDR, establishes the European regulatory framework for medical devices within its scope and has applied since 26 May 2021.
The MDR replaced the previous Medical Devices Directive 93/42/EEC and Active Implantable Medical Devices Directive 90/385/EEC, while introducing substantially strengthened requirements concerning clinical evidence, traceability, post-market surveillance, economic operators and regulatory oversight.
Unlike many other CE-marked products, the conformity assessment route for a medical device is strongly influenced by its risk classification. Except for certain Class I devices that can follow a manufacturer self-declaration route, involvement of an appropriately designated Notified Body is generally required.
This GAR Insight explains MDR scope, intended purpose, device classification, General Safety and Performance Requirements, risk management, clinical evaluation, technical documentation, quality management, Notified Body involvement, UDI, post-market surveillance and CE marking.
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Explore MDR scope, device classification, GSPR, risk management, clinical evidence, conformity assessment, technical documentation, Notified Bodies, UDI, post-market obligations and CE marking.
Understanding Regulation (EU) 2017/745
Regulation (EU) 2017/745 establishes requirements for placing medical devices on the EU market and putting them into service. It applies directly across EU Member States and creates a lifecycle regulatory framework extending from device design and clinical evaluation through production, market entry and post-market surveillance.
The MDR places extensive obligations on manufacturers and also establishes responsibilities for other economic operators, including authorised representatives, importers and distributors.
Is the Product a Medical Device?
Determining whether a product falls within the MDR begins with its intended purpose and mode of action. The Regulation defines medical devices broadly and covers instruments, apparatus, appliances, software, implants, reagents, materials and other articles intended by the manufacturer for specified medical purposes.
Diagnosis
Devices can be intended for diagnosis, prevention, monitoring, prediction or prognosis of disease.
Treatment
Products intended for treatment or alleviation of disease can fall within the MDR definition.
Injury & Disability
Diagnosis, monitoring, treatment, alleviation of or compensation for injury or disability can constitute medical purposes.
Anatomy
Investigation, replacement or modification of anatomy can bring a product within the medical device framework.
Physiological Processes
Devices can be intended for investigation, replacement or modification of physiological or pathological processes or states.
Medical Software
Software can itself qualify as a medical device when its intended purpose satisfies the applicable regulatory definition.
Intended Purpose Drives the MDR Assessment
The intended purpose is one of the most important elements of medical device conformity. It describes the use for which the device is intended according to the information supplied by the manufacturer.
Intended purpose influences qualification, classification, clinical evaluation, risk management, performance claims, testing, labelling, instructions for use and the conformity assessment route.
Who?
Identify the intended patient population and, where relevant, the intended professional or lay user.
What?
Define what the device is intended to diagnose, monitor, prevent, treat, alleviate or otherwise accomplish.
Where?
Consider the intended use environment, including hospitals, clinics, laboratories, homes or other settings.
How?
Define how the device achieves its intended medical purpose and the conditions under which it should be used.
Class I, Class IIa, Class IIb & Class III
Medical devices are classified according to the classification rules in Annex VIII of the MDR. Classification reflects factors including invasiveness, duration of use, anatomical location, active function, implantability and the potential consequences of device failure.
Class I
Generally lower-risk devices. Certain Class I devices can follow manufacturer self-declaration, while sterile, measuring and reusable surgical instrument subclasses involve Notified Body assessment for specified aspects.
Class IIa
Devices presenting a higher level of risk than ordinary Class I products and generally requiring Notified Body involvement.
Class IIb
Devices associated with increased potential risk and generally subject to more extensive conformity assessment.
Class III
Highest-risk devices, including many critical implants, subject to the most stringent conformity assessment requirements.
General Safety & Performance Requirements
Devices must satisfy the applicable General Safety and Performance Requirements, commonly referred to as GSPR, established in Annex I of the MDR.
The manufacturer should determine which requirements apply to the device and document how conformity with each applicable requirement has been demonstrated.
Risk & Benefit
Risks should be acceptable when weighed against the benefits provided to the patient and compatible with a high level of health and safety protection.
Design & Manufacture
Devices should be designed and manufactured to meet applicable safety and performance requirements throughout their intended use.
Chemical & Biological
Materials and substances require assessment appropriate to their nature and patient or user exposure.
Infection & Microbial
Applicable infection, contamination, cleanliness and sterility requirements should be addressed.
Electrical & Mechanical
Relevant electrical, mechanical, thermal, radiation and other physical hazards should be controlled.
Information Supplied
Labels and instructions should provide the information required for identification and safe use of the device.
Risk Management
Risk management is a continuous lifecycle process under the MDR. Manufacturers must identify known and foreseeable hazards, estimate and evaluate associated risks, implement appropriate controls and evaluate residual risk.
Identify Hazards
Determine hazards associated with the device and its use.
Estimate Risk
Evaluate foreseeable sequences of events and resulting harms.
Control Risk
Apply appropriate design, protective and information-based controls.
Verify Controls
Demonstrate that implemented controls are effective.
Residual Risk
Evaluate risks remaining after controls have been implemented.
Benefit-Risk
Evaluate benefit against residual risks where required.
Production Data
Feed manufacturing and quality information back into risk management.
Post-Market Data
Update the assessment using real-world information after market entry.
Clinical Evaluation
Clinical evaluation is a central MDR requirement. Manufacturers must plan, conduct and document a systematic evaluation of relevant clinical data to verify the safety and performance of the device, including its clinical benefits where applicable.
Clinical Literature
Relevant scientific and clinical literature may contribute to the evidence base where its applicability can be justified.
Clinical Investigations
Clinical investigation data may be required where sufficient clinical evidence cannot otherwise be established.
Existing Clinical Data
Available clinical experience and data may contribute where relevance, quality and applicability are demonstrated.
Post-Market Clinical Follow-Up
PMCF supports the continuing evaluation of safety and performance using information obtained after market entry.
Medical Device Technical Documentation
MDR technical documentation should provide structured evidence that the device has been designed, manufactured and assessed in accordance with the Regulation.
Quality Management Under the MDR
Manufacturers must establish, document, implement, maintain, keep up to date and continually improve a quality management system proportionate to the risk class and type of device.
Regulatory Strategy
Processes should support conformity assessment and continuing compliance with applicable regulatory requirements.
Design Controls
Product design and development should be planned, reviewed, verified, validated and controlled.
Supplier Controls
Outsourced processes, suppliers and subcontractors should be controlled according to their effect on device conformity.
Production Controls
Manufacturing processes should consistently produce devices conforming to approved specifications.
CAPA
Nonconformities and quality problems should feed into appropriate corrective and preventive action processes.
Post-Market Processes
PMS, vigilance and feedback should be integrated into the manufacturer’s quality system.
MDR Conformity Assessment
The conformity assessment route depends primarily on device classification and the relevant provisions of the MDR.
| Device Class | Typical Regulatory Position | Notified Body |
|---|---|---|
| Class I | Manufacturer can generally self-declare conformity where the device is not sterile, does not have a measuring function and is not a reusable surgical instrument. | Generally no |
| Class Is | Notified Body involvement applies to aspects concerning establishing, securing and maintaining sterile conditions. | Yes — limited scope |
| Class Im | Notified Body involvement applies to aspects concerning conformity with metrological requirements. | Yes — limited scope |
| Class Ir | Notified Body involvement applies to aspects relating to reuse, including cleaning, disinfection, sterilisation, maintenance and functional testing as applicable. | Yes — limited scope |
| Class IIa | Requires conformity assessment involving an appropriately designated Notified Body. | Yes |
| Class IIb | Requires Notified Body conformity assessment with requirements reflecting the higher risk classification. | Yes |
| Class III | Subject to the most stringent conformity assessment and technical documentation requirements. | Yes |
The Role of the Notified Body
A Notified Body is an independent conformity assessment organisation designated to perform specified activities under the MDR.
Manufacturers requiring Notified Body involvement should select an organisation whose designation scope covers the relevant device technologies and conformity assessment activities.
QMS Assessment
The Notified Body can audit the manufacturer’s quality management system against applicable MDR requirements.
Technical Documentation
Applicable technical documentation can be reviewed as part of the conformity assessment.
Certification
Certificates are issued within the scope of the conformity assessment where applicable requirements have been satisfied.
Surveillance
Continuing surveillance forms part of maintaining certification where Notified Body involvement applies.
Labelling, UDI & Registration
MDR market access involves more than placing the CE mark on the device. Manufacturers must also address applicable identification, traceability, labelling, registration and economic-operator requirements.
Device Labelling
Labels should contain the information required by the MDR and appropriate information for safe identification and use.
Instructions for Use
Where required, instructions should communicate intended purpose, safe-use information, warnings, precautions and other necessary information.
UDI
The Unique Device Identification system supports identification and traceability throughout the supply chain and device lifecycle.
Basic UDI-DI
The Basic UDI-DI acts as a key identifier for a device family within regulatory documentation and relevant database processes.
Economic Operators
Manufacturer, authorised representative, importer and distributor responsibilities should be established as applicable.
Registration
Applicable actor and device registration requirements should be completed using the systems and timelines legally applicable to the device and economic operators.
Post-Market Surveillance & Continuing Compliance
The MDR requires manufacturers to systematically and actively gather, record and analyse relevant information concerning the quality, performance and safety of devices throughout their lifetime.
Post-Market Surveillance
The PMS system collects and evaluates information concerning devices placed on the market.
PMCF
Post-Market Clinical Follow-Up can provide continuing clinical evidence concerning device safety and performance.
Vigilance
Applicable serious incidents and field safety corrective actions must be handled and reported in accordance with MDR requirements.
Trend Reporting
Statistically significant increases in certain incidents or expected undesirable side-effects can trigger reporting obligations.
Risk Management Updates
Post-market information should feed back into the risk-management process and benefit-risk evaluation.
Clinical Evaluation Updates
Clinical evaluation should remain current using relevant post-market and clinical information.
From Medical Device Concept to CE Marking
A successful MDR project is usually easier to manage when regulatory requirements are integrated into product development from the beginning rather than addressed only after the device has been designed.
Qualify
Determine whether the product falls within the MDR.
Define Purpose
Establish the intended purpose, users, patients and claims.
Classify
Apply the relevant Annex VIII classification rules.
Plan Conformity
Select the applicable conformity assessment route.
Manage Risk
Establish and maintain the device risk-management process.
Generate Evidence
Complete appropriate verification, validation and clinical evaluation.
Build Documentation
Compile technical documentation and the required QMS evidence.
Notified Body
Complete third-party conformity assessment where required.
Declare
Prepare and sign the EU Declaration of Conformity.
CE Mark
Apply CE marking in accordance with the applicable MDR requirements.
Register
Complete applicable identification and registration requirements.
Monitor
Maintain PMS, vigilance, clinical and regulatory compliance.
From Medical Device Development to Demonstrable EU Conformity
MDR conformity begins with a clearly defined intended purpose and a defensible regulatory classification. Those decisions determine much of the compliance strategy that follows, including the applicable requirements, clinical evidence, conformity assessment route and degree of Notified Body involvement.
The manufacturer must then establish a connected body of evidence demonstrating that the device satisfies the applicable General Safety and Performance Requirements. Risk management, verification and validation, clinical evaluation, quality management and technical documentation should support one another rather than exist as disconnected compliance documents.
That responsibility continues after CE marking. Post-market surveillance, vigilance, PMCF where applicable, production information and real-world experience must feed back into the manufacturer’s risk management, clinical evaluation and quality processes throughout the device lifecycle.
The Clinical & Safety Question
Does the available technical and clinical evidence demonstrate that the device achieves its intended purpose with risks that are acceptable when weighed against its benefits?
The Conformity Question
Can the manufacturer demonstrate through classification, GSPR assessment, risk management, clinical evaluation, technical documentation, quality controls and post-market processes that the device continues to satisfy Regulation (EU) 2017/745?