CE Marking for Medical Devices

What is CE Marking for Medical Devices?

CE marking for medical devices confirms that a medical device meets the European Union’s requirements for safety, performance, and quality. It is mandatory for placing medical devices on the European market. Under EU MDR 2017/745, CE marking requires manufacturers to demonstrate compliance through proper documentation, risk management, clinical evidence, and conformity assessment. Achieving CE marking builds trust with healthcare professionals, patients, and distributors while enabling smooth access to the EU market.

CE Marking Consultancy for Medical Devices – How We Support You

As experienced CE marking consultants for medical devices, we provide end-to-end consultancy services aligned with EU MDR requirements.

Identify EU MDR 2017/745 regulatory requirements as per your product intended use an application
Identifying the correct conformity assessment route
Supporting documentation preparation and review
Coordinating with Notified Bodies
Supporting audit readiness and responses

We simplify the regulatory process so you can focus on developing safe and effective medical devices.

Step-by-Step CE Marking Process and Role of CE marking Consultants

Medical Device Classification: We help to identify whether your device falls under Class I, Im, Ir, Is,IIa, IIb, or III based on EU MDR classification rules.
Finalization of Testing Requirements: Identify the applicable standard as per the product intended use and application and finalize the performance requirements for the product.
Technical Documentation Preparation: Prepare a complete Technical File including GSPR, Risk Management file, Clinical Evaluation documentation, PMS documents and more.
Selection of Notified Body (if required): We can identify the notified body as per the applicable MDA, MDN, MDS, and MDT codes as per your product intended use and application.
Notified Body audit support: Our team member will be available during the audit to provide support to the manufacturer regarding any technical file queries raised by the auditor.

Technical Documentation (EU MDR)

Clinical Evaluation

Clinical evaluation is essential under EU MDR to demonstrate device safety and performance. Clinical Evaluation documentation includes;

Clinical Evaluation Plans (CEP)
Clinical Evaluation Reports (CER)
Demonstration of Equivalence
Literature search protocol and Report

General Safety and Performance Requirement (GSPR)

Our team will prepare the entire GSPR for you as per your product which comply with the requirement of the EU MDR 2017/745.

Risk Management File

Risk management file prepare as per ISO 14971 which includes;

Risk Management Plan
FMEA
Risk Management report

Post-Market Surveillance (PMS)

Post-Market Surveillance is mandatory to maintain CE marking. Our PMS support includes:

PMS plans and reports
Vigilance and incident reporting
Ongoing compliance monitoring

End-to-End CE Certification Services

EUDAMED Registration

We assist with EUDAMED registration to ensure traceability, transparency, and regulatory compliance under EU MDR and EU IVDR.

UDI Labelling

We support implementation of UDI labelling requirements to ensure device traceability throughout the product lifecycle.

EU Authorized Representative (EU REP)

Non-EU manufacturers must appoint an EU Authorized Representative. We support EU REP coordination to ensure regulatory communication and documentation compliance.

Software validation documentation (where applicable)

Our CE marking consultants also support manufacturers during Notified Body audits and conformity assessments, ensuring a smooth certification process.

Maven Profcon Services LLP provides professional CE marking consultancy for medical devices in accordance with EU MDR 2017/745. We support medical device manufacturers in meeting all regulatory requirements needed for CE certification for medical devices.

Our experienced CE marking consultants provide practical compliance solutions for each requirement of the EU MDR. We help you understand the regulations, prepare the required documentation, and follow the correct process to achieve CE marking.

Frequently Asked Questions

The duration of CE certification for a medical device depends on the device’s risk class, completeness of technical documentation, and Notified Body involvement. Class I devices without Notified Body review usually take 2–4 months, while higher-risk devices (Class IIa, IIb, III) can take 6–18 months or more. Timely preparation of technical files documents can speed up the process.

No., medical devices cannot be sold in the EU without a CE mark.

CE marking is a legal requirement under the EU Medical Device Regulation and confirms that a device meets safety and performance standards. Only limited exceptions apply, such as custom-made devices, clinical investigations, or specific national approvals. Outside of these cases, selling without CE marking is not permitted.

The CE mark for medical devices is a certification label featuring the letters “CE,” which stand for Conformité Européenne (European Conformity). This mark indicates that a medical device complies with European Union regulations, meeting strict standards for safety, health, and environmental protection. Medical devices with a CE mark are legally approved for sale and use within the European Economic Area (EEA).

The notified body issues a certificate or certificates in accordance with the minimum requirements laid down in Annex XII of EU MDR 2017/754 for a period of validity not exceeding five years and shall indicate whether there are specific conditions or limitations associated with the certification.

CE Marking For Medical Devices

What is CE Marking for Medical Devices?

CE Marking Consultancy for Medical Devices – How We Support You

Step-by-Step CE Marking Process and Role of CE marking Consultants