DNV MEDCERT certification services
DNV MEDCERT is your trusted EU Notified Body for medical device and IVD certification, supporting safe market access and regulatory compliance worldwide.
DNV MEDCERT certification services
Challenges in medical device compliance
In today’s highly regulated and innovation-driven healthcare environment, ensuring the safety, performance, and regulatory compliance of medical devices is more critical than ever. Manufacturers face increasing scrutiny from authorities, healthcare professionals, and patients alike.
With the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) in full effect, the role of a competent, efficient, and collaborative Notified Body has never been more vital. Whether you're launching a new product or maintaining compliance across a portfolio, having the right certification partner is essential for timely, safe, and successful market access.
How our medical device services support you
DNV MEDCERT GmbH is a Notified Body (identification number: 0482) designated under both EU MDR (2017/745) and EU IVDR (2017/746). As part of the DNV Group, we specialize in conformity assessment and certification services for medical devices and in vitro diagnostic medical devices (IVDs).
We offer:
- EU MDR and IVDR conformity assessment and certification.
- Quality management system certification (ISO 13485).
- Technical documentation review and evaluation.
- Clinical and performance evaluation assessments.
- Post-market surveillance support.
- Expert guidance throughout the regulatory lifecycle.
- Certification services for legacy products transitioning from MDD/IVDD.
Our role is to help ensure that your devices meet stringent safety and performance requirements so that they can reach patients with confidence and integrity.
Trusted experts in medical device
DNV MEDCERT combines deep regulatory knowledge with a global network of experts in risk management, quality systems, and medical technology. We work closely with you to navigate the complex regulatory landscape while maintaining transparency, independence, and rigor.
Our assessors are specialists with years of hands-on industry and auditing experience, enabling a professional, respectful, and efficient certification process. With a strong commitment to safeguarding health, life, and the environment, we help you deliver safe and effective products to market – confidently and consistently.
Benefits of our medical device services
- Accelerated and reliable market access to the EU.
- Confidence in fulfilling MDR and IVDR obligations.
- Independent certification by an internationally respected Notified Body.
- Expert guidance across the full lifecycle of your medical devices.
- Transparent communication and clear expectations throughout.
- Support for legacy products transitioning to new regulations.
- Integrated services for ISO 13485 and other system standards.
Resources to support your medical device certification journey
Explore key documentation, regulatory updates, and reference materials from DNV MEDCERT to guide your MDR and IVDR conformity assessment and certification processes.
Medical Device Certification
Ensuring safety, compliance, and trust across the medical device lifecycle
Questionnaire for Quotation
A form to apply for a quote for certification services according to MDR, ISO 13485, MDSAP and TCP (Taiwan)
Customer Data Questionnaire
Please complete this form to support audit preparation and ensure accurate certification records.
Application for Certification / Change Notification
A form to apply for certification services according to MDR, ISO 13485, MDSAP and TCP (Taiwan) and/or Change Notification
List of Standard Fees EUR (China)
List of Standard Fees for Conformity Assessment and Certification Activities under the MDR (2017/745), EN ISO 13485, MDSAP and TCP Taiwan for Manufacturers in China: Prices Effective January 1, 2025.
List of Standard Fees EUR
List of Standard Fees for Conformity Assessment and Certification Activities under MDR (2017/745), EN ISO 13485, MDSAP, and TCP III Taiwan: Prices Effective January 1, 2025.
List of Standard Fees USD
List of Standard Fees for Conformity Assessment and Certification Activities under MDR (2017/745), EN ISO 13485, MDSAP, and TCP III Taiwan: Prices Effective January 1, 2025.
Verification of Complaints and Appeals
How to submit a complaint or appeal and understand the review and decision process.
Realization of Certification of QM System and Conformity Assessment of Medical Devices
This document has replaced Procedure for the Certification and Conformity Assessment of MD and QMS
Quality Policy
DNV MEDCERT’s commitment to impartial, competent and consistent certification services.
General Order and Payment Conditions
Contractual terms and payment conditions for DNV MEDCERT certification services.
Declaration of Interest with regards to Impartiality
Statement on independence and management of conflicts of interest in certification activities.
List of conformity assessed products and critical suppliers
Overview of products and key suppliers covered by conformity assessment.
ISO 13485 Seal - Guidelines to use
How to correctly use the DNV certification seal to communicate compliance to the market.
MDR Conformity Assessment Procedures - Chart
Visual overview of the MDR conformity assessment workflow, including key steps from quotation to certification issuance
MDR Initial Certification Process - Chart
Step-by-step guidance for initial MDR assessments - covering documentation review, audit stages, and certificate finalization
