Medical Device Regulatory Consultancy Services for Europe

Steps to Get a CE Mark

To obtain CE marking, manufacturers must follow an appropriate conformity assessment route based on the classification and risk level of their medical device. The selected route determines the extent of Notified Body involvement and the regulatory requirements that must be met. Obtaining CE marking requires manufacturers to follow a structured conformity assessment process that demonstrates compliance with applicable European regulations. The process typically involves the following steps:

1. 01

   Define the Intended Purpose

   Clearly establish the device's intended use, target population and clinical application.

2. 02

   Identify Applicable Regulatory Requirements

   Determine whether the device is governed by MDR or IVDR and identify relevant harmonized standards, common specifications, and MDCG guidance documents.

3. 03

   Qualification of device as a Medical Device

   As per MDR / IVDR Article 2.

4. 04

   Classify the Device

   Assign the appropriate risk class according to the classification rules in the applicable regulation.

5. 05

   Select the Conformity Assessment Route

   Choose the conformity assessment procedure based on the device classification and regulatory requirements.

6. 06

   Implement a Quality Management System (QMS)

   Establish and maintain a compliant QMS covering design, manufacturing, and post-market activities.

7. 07

   Develop the Device and Technical Documentation

   Design, manufacture, validate, and document the device to demonstrate compliance with regulatory requirements.

8. 08

   Select an Appropriate Notified Body

   Identify a Notified Body designated under the applicable MDR or IVDR scope and competent to assess the device technology, classification, and conformity assessment route. Early engagement supports efficient certification planning and assessment timelines.

9. 09

   Submit a Pre-Application to the Notified Body (NB)

   Provide preliminary information for verification of device scope, classification, and preparation of a conformity assessment quotation.

10. 10

    Lodge the Formal Application

    Submit the required QMS and technical documentation, together with the formal application and supporting information.

11. 11

    Application Review and Contract Agreement

    The NB reviews the application for completeness and eligibility, and upon acceptance, establishes a written agreement with the manufacturer.

12. 12

    Conformity Assessment

    The NB performs the required audits, technical documentation is reviewed thoroughly i.e. GSPR as per Annex I, Technical documentation as per Annex II, Post-Market Surveillance information as per Annex III, and any applicable consultation procedures.

Regardless of the conformity assessment route selected, manufacturers must need to prepare and maintain technical documentation in accordance with Annex II and establish Post-Market Surveillance (PMS) documentation as required by Annex III. These documents serve as the foundation for demonstrating ongoing compliance throughout the device lifecycle.

1. 13

   Final Review and Certification Decision

   The NB independently reviews the assessment results, verifies resolution of non-conformities, and decides whether certification can be granted.

2. 14

   Issue the EU Declaration of Conformity and Affix the CE Mark

   Following successful certification, the manufacturer prepares the EU Declaration of Conformity and affixes the CE marking in accordance with Annexes IV and V of the MDR/IVDR. Where applicable, the Notified Body identification number shall accompany the CE mark. The CE marking must comply with the prescribed proportions and have a minimum height of 5 mm, unless waived for small-scale devices, demonstrating conformity with regulatory requirements and enabling placement of the device on the European market

1. 15

   Certificate Issuance and Post-Certification Surveillance

   NB issues the MDR/IVDR certificate and conducts ongoing surveillance activities to verify continued compliance throughout the certificate validity period.

MEDREG helps manufacturers to understand and meet the applicable requirements of the EU Medical Device Regulation (EU MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (EU IVDR 2017/746).

From device classification and technical documentation to conformity assessment and Notified Body coordination, we provide structured guidance throughout your CE marking journey.

Our goal is to help you build a strong regulatory foundation for safe, compliant and successful entry into the European market. In accordance with EU MDR 2017/745 and EU IVDR 2017/746, we offer complete regulatory consulting services to assist medical device manufacturers in obtaining and retaining the CE mark.

Our CE marking services are designed for

• Medical device manufacturers seeking European market access.
• IVD manufacturers preparing for EU IVDR compliance.
• Medical device manufacturers preparing for EU MDR compliance.
• Manufacturers transitioning from legacy European directives to the applicable MDR or IVDR requirements.
• Manufacturers preparing for Notified Body assessment.
• Manufacturers requiring technical documentation gap assessments.
• Manufacturers seeking support with clinical evaluation, performance evaluation, or biological evaluation.
• Manufacturers looking to strengthen their QMS and post-market compliance processes.

MEDREG - Your Trusted Partner for CE Marking & European Market Access