Medical Device Market Approval & Certification

In Vitro Diagnostic Medical Device Regulation Resources

Be confident of IVD medical device market approval

Be confident of IVD medical device market approval

ensure a smooth process while complying with the EU in vitro DIAGNOSTIC medical device regulation (IVDR)

The complex development process for in vitro diagnostic medical devices combined with the anticipated changes, can make the transition a complicated and time-consuming process for most device manufacturers. The resources below provide information and checklists to prepare you for EU's IVDR. Download these resources to ensure the latest information and guidance in your IVDR journey.

(1) Audit checklists

IVDR QM System Requirements

This checklist will help you as a manufacturer and the audit team to prepare for the audit and see at a glance where the requirements are fulfilled / described.

Download it here

IVDR Technical Documentation Submission Requirements

This checklist will help you to prepare the Technical Documentation for submission to the notified body.

Download it here

(2) CERTIFICATION GUIDANCE DOCUMENT

EU’s In Vitro Diagnostic Medical Device Regulation

Manufacturers of in vitro diagnostic medical devices seeking market access to the European Union (EU) must comply to the new in vitro diagnostic medical device regulation framework. Read on to find out the changes and what to expect.

Download it here

Sampling of Class B and C IVD Devices

Understand how the requirements of sampling for Class B and Class C devices under the IVDR are implemented by TUV SUD and review additional practical explanations/ implications.

Download it here

Legacy Products under IVDR

Do you know what are the requirements for products that were already on the market under IVDD? We answer your questions and shed some light on the whole issue of so-called Legacy Products and how to transition into IVDR.

Download it here 

IVDR Companion Diagnostics (CDx)

The In-vitro Diagnostic Medical Devices Regulation (IVDR) replaces the old In Vitro Diagnostic Medical Device Directive (IVDD) and introduces significant implications for the regulation of CDx. Download the brochure to learn how to successfully complete the CDx IVDR certification.

Download it here

(3) INFOGRAPHICS

The European Union In Vitro Diagnostic Medical Device Regulation

If you are looking to place your IVD medical devices on the European Market but are unsure of what needs to be done, here is a simple infographic to help you out.

Download it here 

How TÜV SÜD can assist you?

If you would like to request TÜV SÜD services for IVDR certification, please consult our IVDR Service registration page.

Request for an IVDR Service Registration today

Independently from the IVDR certification process, TÜV SÜD can assist with testing (e.g. physical testing, cybersecurity) of your IVD medical device. For more information, please visit the following webpage.

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