CE Marking — EU MDR 2017/745

Who Needs CE Marking?

Is Your Medical Device Going to Be Sold in the European Union?

If you are a medical device manufacturer planning to place a medical device on the EU market, you may need to demonstrate conformity with the EU MDR and affix the CE marking before placing the device on the market, subject to the applicable regulatory requirements and exclusions.

Medsure Consulting supports manufacturers who need to establish their regulatory pathway and prepare the documentation required for CE Marking under EU MDR 2017/745.

Medsure Can Support:

• New medical device manufacturers preparing their first CE Marking

• Existing manufacturers transitioning or updating their MDR documentation

• Manufacturers outside the EU planning to enter the European market

• Companies developing new medical devices

• Manufacturers with an existing technical file requiring an MDR gap assessment

• Manufacturers preparing for Notified Body assessment

• Manufacturers whose documentation requires remediation or restructuring

• Companies reviewing the regulatory classification of a medical device

For manufacturers established outside the EU, an EU Authorised Representative is required under the MDR, subject to the applicable requirements.

Our CE Marking Support

Regulatory Support Built Around Your Device

01 — Regulatory Assessment & Device Classification

We assess your medical device, intended purpose, characteristics, and applicable regulatory requirements to establish the appropriate EU MDR pathway.

Our support includes:

• Device and intended-purpose assessment

• Regulatory applicability assessment

• Medical device classification

• Applicable MDR requirements

• Regulatory pathway planning

02 — Technical Documentation

We support the preparation and organization of the technical documentation required to demonstrate compliance with EU MDR.

This may include:

• Device description and specifications

• Intended purpose

• Applicable standards

• GSPR documentation

• Risk management documentation

• Clinical evaluation documentation

• Verification and validation evidence

• Labelling and IFU

• Declaration of Conformity

03 — GSPR Compliance

The General Safety and Performance Requirements form a key part of the EU MDR compliance framework.

Medsure Consulting supports manufacturers in identifying applicable GSPRs and establishing the appropriate evidence and documentation to demonstrate compliance.

04 — Risk Management

We support the preparation and documentation of the medical device risk management process, including:

• Risk management planning

• Hazard identification

• Risk analysis

• Risk evaluation

• Risk control

• Residual risk evaluation

• Benefit-risk considerations

05 — Clinical Evaluation

Clinical evidence is an important component of the EU MDR regulatory framework.

Medsure Consulting supports manufacturers with the preparation and organization of clinical evaluation documentation appropriate to the device and its regulatory requirements.

This can include:

• Clinical Evaluation Planning

• Clinical evidence assessment

• Literature evaluation

• Clinical Evaluation Report support

• Clinical evidence gap assessment

06 — Conformity Assessment & Notified Body Support

Where Notified Body involvement is required, we support manufacturers in preparing their documentation and regulatory package for assessment.

Our support can include:

• Conformity assessment preparation

• Technical documentation review

• Regulatory gap identification

• Audit preparation

• Response to observations or non-conformities

• Documentation support during the assessment process

The CE Marking Process

From Device Assessment to Regulatory Readiness

01 — Understand
Assess the device, intended purpose, technology, and claims.

04 — Document
Prepare the required technical and regulatory documentation.

05 — Demonstrate Compliance
Establish evidence for safety, performance, risk, clinical and applicable regulatory requirements.

06 — Conformity Assessment
Complete the applicable conformity assessment process and support Notified Body interaction where required.

02 — Classify
Determine the applicable EU MDR classification.

03 — Plan
Establish the regulatory and conformity assessment pathway.

Frequently asked questions

What is CE Marking under EU MDR 2017/745?

CE Marking for medical devices demonstrates that the device has undergone the applicable conformity assessment process and meets the relevant requirements of EU MDR 2017/745.

Does every medical device require a Notified Body?

Not every device follows the same conformity assessment route. The requirement for Notified Body involvement depends on the applicable regulatory pathway and device classification.

How is a medical device classified under EU MDR?

Classification is determined using the classification rules established under EU MDR 2017/745, considering factors such as intended purpose and the characteristics of the device.

What documents are required for CE Marking?

The documentation depends on the device and its regulatory pathway. It can include technical documentation, GSPR documentation, risk management, clinical evaluation, verification and validation evidence, labelling, IFU, and other applicable records.

How long does CE Marking take?

The timeframe varies depending on the device, classification, documentation readiness, testing requirements, conformity assessment route, and whether Notified Body assessment is required.

Can Medsure review existing EU MDR documentation?

Yes. Existing documentation can be reviewed to identify regulatory gaps, inconsistencies, missing evidence, and areas requiring further development.

Planning CE Marking for Your Medical Device?

Let Medsure Consulting help you understand your EU MDR 2017/745 requirements and establish a structured regulatory pathway for your device.