DQS Medizinprodukte GmbH is a designated Notified Body under EU MDR 2017/745 (Identification Number 0297), combining deep medical-device expertise with transparent planning to support timely CE marking and sustained market access across the European Union, the second largest market for medical device manufacturers.
Auditors with deep sector expertise and experience from the industry.
Each client has a dedicated customer advisor and Regulatory Affairs Manager.
Audits and Technical File Reviews supported across your sites from our 80 offices.
EU MDR certification is the gateway to placing medical devices on the European market and a credibility signal recognized far beyond it in other regulated markets. It also demonstrates that a manufacturer has followed a rigorous conformity assessment process, supporting trust with authorities, distributors, hospitals, and procurement teams. This creates a stronger foundation for reliable EU market access, customer confidence, and sustainable growth.
The value of certification extends beyond external proof of conformity. Many organizations use recurring audits and assessment processes as a framework for continuous improvement, operational transparency, and stronger cross-functional alignment. In practice, companies often report effects such as:
The regulatory framework under Regulation (EU) 2017/745 on medical devices (EU MDR) continues to evolve. Recent measures include Commission Delegated Regulation C(2026)1798, which amends Article 61(6)(b) MDR and expands the list of implantable and class III devices that may, under specific conditions, be exempt from the obligation to perform clinical investigations.
A second measure, Commission Delegated Regulation C(2026)1809, amends Article 52(4) MDR and expands the list of class IIb implantable devices for which the Notified Body is not required to assess the technical documentation for every individual device during conformity assessment.
In addition, Commission Implementing Regulation (EU) 2026/977 of 4 May 2026 lays down uniform quality management and procedural requirements for conformity assessment activities carried out by Notified Bodies under the MDR. It applies from 25 February 2027 and is expected to bring more structure, transparency, and predictability to conformity assessment timelines and procedures.
The MDR remains fully in force. Starting your conformity assessment now with DQS means working with a designated Notified Body that closely monitors regulatory developments and adapts its audit and assessment practices as new requirements become applicable.
Save time and internal effort with a clearly structured certification process. Request your personal quote for your EU MDR 2017/745 certification now.
EU MDR certification supports a broad range of medical-device organizations placing products on the European market:
• Medical device manufacturers with Class I sterile, measuring or reusable surgical devices, as well as Class IIa, IIb and III devices
A clear process means fewer questions and faster results. These are the stages of your EU MDR 2017/745 certification with DQS — transparent from start to finish.
The process begins with an initial exchange of information. DQS collects the key details needed to understand your certification scope, including your project description, intended use, device classification, and basic company and product data.
Based on this information, DQS prepares a tailored cost estimate, including the expected effort for the QMS audit and technical documentation review. This first step gives you a clear overview of the scope, expected requirements, and planning basis for your MDR certification project.
Once you decide to proceed, you submit the formal application together with the necessary company, product, and technical documentation. DQS reviews the application, checks the completeness of the submitted information, and may request additional clarification where needed.
After acceptance of the formal application, the conformity assessment procedure under Regulation (EU) 2017/745 officially begins. If the submitted information changes the original project scope, the cost estimate may be updated accordingly.
DQS then plans the audit program based on your submitted information. This includes both the review of technical documentation at product level and the evaluation of your Quality Management System at system level.
During the initial system analysis, DQS assesses your QMS documentation and processes to determine readiness for the next stage. Technical documentation is reviewed according to the relevant device scope and sampling approach. Findings are summarized in reports, giving you the opportunity to address potential gaps before the main assessment continues.
The detailed technical documentation review evaluates whether your medical device documentation demonstrates compliance with MDR requirements, including safety, performance, risk management, clinical evaluation, post-market surveillance, and applicable regulatory obligations.
In parallel, the Stage 2 system assessment verifies the effective implementation of your QMS, usually on-site at your premises. DQS evaluates whether your processes support continued compliance with MDR and with the specifications described in your technical documentation. The results are documented in a system evaluation report, including any nonconformities and the certification recommendation.
After completion of the assessments, the Certification Decision Board reviews the results and decides whether certification can be granted or whether further action is required.
Following a positive certification decision, DQS issues the MDR certificate and the detailed system assessment report. This enables CE marking and supports access to the European market for the devices covered by the certificate.
MDR certification continues after certificate issuance. To maintain certification, DQS performs regular surveillance activities, including annual QMS surveillance audits, technical documentation assessments according to a defined sampling plan, and unannounced audits where required.
If changes are made to your QMS or technical documentation during the certification cycle, they may need to be submitted to DQS for evaluation. MDR certificates are valid for a maximum of five years and can be renewed through recertification.
• Quality management system implemented and operating in line with ISO 13485 and MDR Annex IX.
• Technical documentation prepared per Annexes II and III for each device family.
• Clinical evaluation report completed, with clinical evidence appropriate to device class.
• Post-market surveillance, vigilance, and PMCF plans documented.
• Internal audit and management review cycles completed at least once.
Once your organization meets these requirements, you are ready to contact DQS to begin your EU MDR 2017/745 certification.
EU MDR certification can be efficiently combined with ISO 13485, ISO 14971, MDSAP, and ISO 27001 audits. A bundled approach reduces audit duplication and consolidates planning across regulatory, quality, and information security requirements.
From inquiry to certificate, most manufacturers complete initial conformity assessment within 9 to 18 months — depending on device class, complexity, and readiness of technical documentation. Capacity is reserved early to support timely CE marking. Learn more in our EU MDR 2017/745 Knowledge Center.
EU MDR certificates are valid for up to five years, with mandatory annual surveillance audits — including unannounced audits where required. Recertification confirms ongoing conformity. Learn more in our EU MDR 2017/745 Knowledge Center.
Cost depends on device class, number of device families, technical documentation scope, and the size and number of sites in your QMS. Request a quote to receive a tailored offer covering audit days, technical reviews, and surveillance planning.
Effort concentrates on preparing technical documentation, clinical evaluation, and post-market surveillance evidence. Mature ISO 13485 systems shorten the path significantly. Learn more in our EU MDR 2017/745 Knowledge Center.
