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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:
- Two Designated Notified Bodies – Offering consistent, high-quality assessments.
- Global Recognition – DEKRA has offices supporting the Notified Body’s MDR CE marking activities in a number of international regions.
- Extensive Industry Experience – DEKRA has a proven track record in assessing medical devices across various categories.
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.
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.
The Medical Device Regulation (MDR) (EU) 2017/745 is the EU legislation that governs the safety and performance requirements for medical devices sold within the European Economic Area (EEA). It replaced the Medical Device Directive (MDD) and Active Implantable Medical Devices Directive (AIMDD) as of May 26, 2021. The MDR aims to establish a higher standard of safety and traceability for medical devices.
CE marking under MDR demonstrates that a medical device meets the EU’s essential requirements for safety and performance. It is a mandatory step for any medical device to be sold in the European market. For Class 1s,m,r, Class IIa, IIb, and III devices, CE marking can only be affixed after a successful conformity assessment carried out by a designated Notified Body. Without CE marking, manufacturers are not legally permitted to market or distribute their devices within the EU.
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.
DEKRA is a designated Notified Body under MDR (EU) 2017/745, providing independent and impartial assessments for medical devices. As a Notified Body, DEKRA reviews the manufacturer’s technical documentation, clinical data, and other requirements to verify compliance with EU regulations. After successful assessment, DEKRA issues certification for eligible devices in accordance with MDR, allowing CE marking.
The duration of the MDR CE marking process varies depending on factors such as the quality of the technical dossier and the availability of resources. Typically, the process takes between 12 to 18 months to complete. It is essential to begin early to prevent delays in market access.
MDR certificates are valid for five years, provided that the device and quality system continue to comply with applicable requirements.
Annual surveillance audits and, where required, periodic reviews of post-market surveillance documentation (e.g., PSUR) are conducted. If any significant changes are made to the device or its manufacturing process, manufacturers must submit updates to their Notified Body.
