Medical Devices

Medical Devices

Brochure17 November 2025

In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR)

This brochure provides an overview of DNV’s role as a designated Notified Body supporting manufacturers from pre-application to post-certification, ensuring compliance, efficiency, and timely EU marke...

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Medical Devices

Brochure17 November 2025

Medical Device Regulation (EU) 2017/745 (MDR)

This brochure provides an overview of the EU Medical Device Regulation (MDR), which ensures the safety, quality, and performance of medical devices placed on the European market.

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Medical Devices

Flyer17 November 2025

Technical Cooperation Programme (TCP III)

This one-pager explains DNV’s role in the Technical Cooperation Programme on Exchange of Medical Device Quality Management System Regulation and ISO 13485 Audit Reports (TCP III). The programme facili...

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Medical Devices

Flyer17 November 2025

MDSAP service audit process

This one-pager provides an overview of DNV’s structured and impartial MDSAP audit process, which satisfies the regulatory requirements of five major markets: Australia, Brazil, Canada, Japan, and the ...

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Medical Devices

Flyer17 November 2025

ISO 13485 Service

This one-pager provides an overview of DNV’s ISO 13485 certification process, explaining how we assess compliance through structured and impartial audits.

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Medical Devices

Paper17 November 2025

IVDR Certification Process Overview

This one-pager outlines the step-by-step process DNV follows for IVDR certification - from application and evaluation to audit, review, and final certification.

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Medical Devices

Brochure17 November 2025

IVDR Milestones Readiness Guide

This brochure outlines the updated IVDR transition timelines under Regulation (EU) 2024/1860. It helps manufacturers understand the new milestone requirements, prepare compliant transition plans, and ...

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Medical Devices

Brochure17 November 2025

Medical Devices Brochure

This brochure provides an overview of DNV’s medical device certification and regulatory services worldwide, including MDR, IVDR, ISO 13485, MDSAP, and TCP III. It highlights how DNV supports manufactu...

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Medical Devices

Brochure14 November 2025

IVDR Compliance Guide

This brochure provides a clear overview of the EU In Vitro Diagnostic Regulation (IVDR), including key requirements, compliance steps, and transition timelines. It also explains how DNV supports manuf...

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Medical Devices

Brochure14 November 2025

IVDR Compliance Guide (Korean)

This brochure is available in Korean and provides a clear overview of the EU In Vitro Diagnostic Regulation (IVDR), including key requirements, compliance steps, and transition timelines. It also expl...

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Medical Devices

Brochure13 November 2025

Medical Devices Brochure (Chinese)

This brochure is available in Chinese and provides an overview of DNV’s medical device certification and regulatory services worldwide, including MDR, IVDR, ISO 13485, MDSAP, and TCP III. It highlight...

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Medical Devices

Webinar06 November 2025

Watch the on-demand video recording

In this DNV webinar, experts explored how IVD manufacturers can achieve and maintain compliance under the In Vitro Diagnostic Regulation (IVDR). The session covered practical strategies, common challe...

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Main Websites

Local Websites

Medical Devices

In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR)

Medical Device Regulation (EU) 2017/745 (MDR)

Technical Cooperation Programme (TCP III)

MDSAP service audit process

ISO 13485 Service

IVDR Certification Process Overview

IVDR Milestones Readiness Guide

Medical Devices Brochure

IVDR Compliance Guide

IVDR Compliance Guide (Korean)

Medical Devices Brochure (Chinese)

Watch the on-demand video recording