DNV MEDCERT certification services
DNV MEDCERT Certification and Notified Body for Medical Devices
DNV MEDCERT certification services
DNV MEDCERT GmbH is one of the largest German Certification and Notified Bodies and is based in Hamburg, Germany. The identification number as a Notified Body is 0482.
Since 1994 MEDCERT has specialized in auditing, certification and conformity assessment of quality management systems and medical devices. MEDCERT became part of DNV in January 2022 (read the press release here).
Our services
DNV MEDCERT audits and certifies quality management systems and medical devices for conformity with EN ISO 13485 and compliance with European regulatory requirements for medical devices as well as national laws. It exclusively certifies medical devices and healthcare products.
Due to a high level of in-house expertise and competence, we are able to certify even highly innovative and complex devices as well as drug-device combinations.
DNV MEDCERT services include:
- Notified Body assessment according to Regulation (EU) 2017/745 - the European Medical Device Regulation
- Certification according to ISO 13485
- Certification according to MDSAP (Medical Device Single Audit Program) for Australia, Brasil, Canada, USA, Japan
- Audits under TCP (Technical Cooperation Programme) for Taiwan
Contact medcert-info@dnv.com for more information.
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
| Important MDR Documents |
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Important MDR Documents |
| Important MDR Documents |
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Important MDR Documents |
