In-vitro-Diagnostic Medical Device Regulation (IVDR)
CE Certification IVDR (EU) 2017/746
In-vitro-Diagnostic Medical Device Regulation (IVDR)
Medical Device Certification Services
Comprehensive Certification for the Medical Device Industry
To ensure the safety, quality, and performance of medical devices entering global markets, manufacturers of medical devices must meet strict international regulations and standards. To verify that all applicable regulations and standards are met, medical device certification by an independent body is essential.
Under DEKRA Medical Services, multiple specialized certification bodies operate across different regulatory frameworks. These include designated Notified Bodies for the EU (NB 0124 and NB 0344), a UK Approved Body (8505), and a recognized Auditing Organization under the Medical Device Single Audit Program (MDSAP). Together, they bring over 30 years of experience in medical device conformity assessments — including high-risk and in vitro diagnostic devices (IVDs).
We are one of the leading global certification bodies for companies involved in the development, manufacturing, and distribution of medical devices, including high-risk and innovative products. With a well-established global presence, we support clients accessing key markets including the EU, UK, USA, Canada, Brazil, Australia, Japan, Singapore and Taiwan.
Within the DEKRA group, our designated and accredited certification bodies offer comprehensive medical device certification services. These services are supported by deep industry knowledge, efficient communication processes, and a coordinated international presence.
Each DEKRA entity conducts independent and thorough conformity assessments in accordance with its specific designation or accreditation — covering key regulatory frameworks such as EU MDR, IVDR, UKCA, ISO 13485, and MDSAP.
Why Choose DEKRA for Medical Device Certification?
- Trusted Notified and Approved Body – DEKRA Certification B.V. and DEKRA Certification GmbH are designated for MDR and DEKRA Certification B.V. for IVDR as well, while DEKRA Certification UK Ltd is a UK Approved Body for UKCA marking.
- Comprehensive Certification Coverage – We assess a wide range of medical devices and in vitro diagnostic devices, including high-risk and innovative technologies.
- Expert Team of Professionals – Our team is passionate about medical device safety and has extensive experience in and knowledge of medical devices and regulatory frameworks.
- Global Presence with Local Expertise – Our certification experts are located across several countries in Europe and Asia, enabling responsive and localized support for global clients.
What Does the DEKRA Certification Process Look Like?
Medical Device Certification Services
EU MDR / IVDR Certification
Within the DEKRA group, two designated Notified Bodies provide conformity assessments under European regulations.
These Notified Bodies conduct thorough assessments to verify compliance with the applicable EU regulatory requirements. Manufacturers that meet the MDR or IVDR requirements are eligible to apply the CE marking — a mandatory prerequisite for placing medical devices or IVDs on the EU market.
DEKRA Certification GmbH (NB 0124)
DEKRA Certification B.V. (NB 0344)
ISO 13485 Certification
DEKRA offers ISO 13485 certification through its accredited certification bodies within the DEKRA group.
ISO 13485 is the internationally recognized and harmonized standard for Quality Management Systems (QMS) specific to the medical device industry. It applies to organizations involved in any stage of a medical device’s lifecycle — from design and development to production, distribution, and post-market activities. The standard supports a process-oriented approach to ensure product safety, consistent quality, and compliance with global regulatory requirements.
DEKRA Certification B.V.
DEKRA Certification GmbH
DEKRA Certification UK Ltd
MDSAP (Medical Device Single Audit Program) Certification
The Medical Device Single Audit Program (MDSAP) aims to enhance efficiency and safety by allowing a single audit to satisfy the varying requirements of multiple regulatory authorities MDSAP audits conducted by DEKRA can support manufacturers in meeting regulatory expectations for Canada (mandatory) and facilitate compliance pathways for Australia, Brazil, Japan, and the USA. DEKRA conducts MDSAP audits based on ISO 13485 and additional country-specific criteria, streamlining the certification process and facilitating global market access.
UKCA Certification
UKCA (UK Conformity Assessed) came into force when the UK left the European Union.
This marking is placed on medical devices and IVD’s to demonstrate conformity with the Medical Device Regulation (MDR 2002, as amended).
Technical Cooperation Program (TCP)
Both DEKRA Certification GmbH and DEKRA Certification B.V. participate in the Technical Cooperation Program (TCP), which facilitates the exchange of regulatory audit reports between EU Notified Bodies and authorized auditing organizations in Taiwan.
Participation in TCP supports manufacturers seeking market access in Taiwan by enabling the recognition of EU audits for regulatory purposes. Compliance with Good Manufacturing Practice (GMP) and ISO 13485 requirements plays a key role in the acceptance of audit outcomes by the Taiwan Food and Drug Administration (TFDA).
Singapore Accreditation Council (SAC) certification
Medical device companies in Singapore are required to be licensed by the Health Sciences Authority (HSA) to manufacture, import, or supply by wholesale. Manufacturers, importers, or wholesalers with a location in Singapore can apply for ISO 13485 certification under SAC accreditation. DEKRA Certification B.V. is accredited by the Singapore Accreditation Council (SAC) to issue ISO 13485:2016 certificates. This supports manufacturers, importers, and distributors in meeting the quality system requirements for regulatory compliance in Singapore. To learn more and view our current scope of accreditation, visit the SAC accreditation search page..
Our Commitment to Medical Device Manufacturers
At DEKRA, we provide reliable medical device certification services.
Contact DEKRA for Medical Device Certification Support.
Ready to have your medical device certified? Contact DEKRA today to learn more about our certification services.
Dedicated Approaches
From Onboarding to Certification: DEKRA's Transparent Project Approach
ISO 13485 Certification
Quality Management System
ISO 13485 Certification
Medical Device Regulation (MDR)
CE Certification MDR (EU) 2017/745
Medical Device Regulation (MDR)
Medical Device Single Audit (MDSAP)
Standardizing how we audit medical devices on a global scale
Medical Device Single Audit (MDSAP)
UKCA Marking for Medical Devices
DEKRA is a UK Approved Body for medical certification.
UKCA Marking for Medical Devices