Medical Device Regulation (MDR)

CE Marking Under the Medical Device Regulation (EU) 2017/745 (MDR)

Gaining Access to the European Market: MDR CE Marking with DEKRA

Medical device manufacturers must comply with the Medical Device Regulation (MDR) (EU) 2017/745 to legally place their products on the European market. CE marking confirms that a device meets the safety, performance, and regulatory standards required in the EU.

As a Notified Body, DEKRA provides conformity assessments for the following medical device risk classes:

Class III
Class IIb
Class IIa
Class I sterile / Class I reusable / Class I measuring

DEKRA – Notified Body for MDR CE Marking

Within DEKRA Medical Services there are two MDR-designated Notified Bodies.

DEKRA’s Notified Bodies for MDR:

DEKRA Certification B.V. (NB 0344) – based in the Netherlands
DEKRA Certification GmbH (NB 0124) – based in Germany

These Notified Bodies are authorized under the Medical Device Regulation (EU) 2017/745 (MDR) to carry out conformity assessments of medical devices and, issue the relevant certificates, including those related to the provisions of Article 16 of the MDR.

Why Choose DEKRA for MDR CE Marking?

DEKRA provides a reliable and efficient process for obtaining CE marking under the MDR.

Here’s why DEKRA is the right choice for your certification needs:

What Does the DEKRA Certification Process Look Like?

At DEKRA, we offer a unique approach to guide customers through the entire certification journey—from initial onboarding to ongoing surveillance—via a dedicated expert serving as your single point of contact. To further streamline the process, we provide tailored review options such as expedited reviews, modular reviews, and early-stage assessments—designed to support a more predictable and efficient conformity assessment process.

In addition, we offer specialized approaches tailored to effectively support different types of manufacturers—ranging from start-ups and first-time applicants, to large international organizations, and developers of breakthrough innovations.

Get in touch with us to explore how we can best support your certification needs.

Our newcomers' approach is suited to SMEs, start-ups, and manufacturers dealing with new regulations.

Tailored on-boarding package addressing new regulatory aspects
Extra clarification as needed addressing the novel regulatory aspects and DEKRA processes
Regulatory and clinical protocol review to address the critical aspects in an early stage

Our large manufacturers program is suited to large manufacturers with several parallel projects and sites.

Regular project pipeline meetings and strategic alignment reviews
Annual executive management evaluation meetings
Clarification of manufacturers’ products and processes, when a new project manager is assigned

Our breakthrough innovations program is suited to manufacturers of true novel devices

Tailored on-boarding package addressing the assessment process (CECP) of the novel technology
Assigned an expert team
Clarification program for DEKRA expert team
Regulatory and clinical protocol review to address the novel aspects in an early stage

Begin your path to CE marking for your medical device under MDR with DEKRA’s impartial certification services. Our Notified Body conducts thorough conformity assessments to verify your device’s compliance with EU regulatory requirements. Contact us.

Important documents and more information about DEKRA Certification GmbH (Notified Body 0124 and DEKRA Certification B.V. (Notified Body 0344)

FAQs

What is the MDR (EU) 2017/745?

Why do medical devices need CE marking under MDR?

How can I place my medical devices on the European market ?

To obtain CE marking, manufacturers must undergo a conformity assessment with a Notified Body such as DEKRA. The process includes:

1. Request a Quotation

Complete the pre-application form: Provide information about your organization, scope, quality management system, and your technical dossier(s).
Receive a detailed proposal: Request a quotation of estimated costs, audit duration and timelines, and our terms and conditions.

2. Choose DEKRA

Accept the quotation: A dedicated DEKRA project manager and Support Office will be assigned by the relevant Notified Body to oversee the entire MDR certification process, ensuring effective communication and coordination throughout all stages.
Submit the formal application: This is then followed by DEKRA’s review of the application and signing the formal agreement between the two parties

3. On-Site Activities

Comprehensive Audit Plan: The project manager will create an audit plan covering timelines and key activities, including scheduling the audit. This ensures sufficient time for preparation and addressing any identified issues. The certification audit evaluates the implementation and effectiveness of the quality management system. The audit report may include nonconformities, and an initial report is presented during the closing meeting. Clients must respond with a corrective action plan to address nonconformities.

4. Off-site Activities

Off-site Technical File Review: During a technical file review, DEKRA’s team of file reviewers evaluates whether the medical device meets the essential safety and performance requirements outlined in the MDR. It includes an assessment of the device's design, intended use, clinical evaluation, risk management, manufacturing processes, and post-market surveillance plans.

5. Certification

Verification of Compliance by DEKRA Certification Management: After successfully completing the audit, the technical file review, and resolving all nonconformities, a final review of all reports is conducted. If all elements are confirmed to be in compliance with the MDR, then DEKRA will be able to issue an EU MDR certificate covering the quality management system and products.

What is the role of DEKRA as a Notified Body?

How long does the MDR CE marking process take?

How often do I need to renew my certification?