In Vitro Diagnostic Regulation (IVDR)

You must apply to the Notified Body (NB) by the dates listed below. You must then sign a contract with an NB by 26th September of the respective years. Your products can then continue to be placed on the market until the end of the transition period, as indicated below, depending on the Class of your devices.

For all legacy devices, certain requirements of the IVDR regulation, including post-market surveillance, vigilance, registration of economic operators, and market surveillance are applicable since the date of application of the IVDR (May 26, 2022) as per article 110 (3).

See the infographic below for a summary of the timeline of IVDR Transitional Provisions:

How you Can prepare

• Ensure that your quality management system complies with the requirements of IVDR Article 10(8)

• Prepare your technical documentation in accordance with IVDR Annex II & III
  
  • Assess whether existing information (e.g. from IVDD or ex-EU applications) is adequate to demonstrate compliance 
  • Generate required data to address any gaps 
  • Refer to our best practice guide for IVDR technical documentation 

• Engage with us early on to discuss your needs
  
  • Our Structured Dialogue provides an opportunity to discuss the procedural and regulatory requirements with us before lodging your application for IVDR conformity assessment  
• Keep informed about new regulations and guidance
  
  •  Subscribe to our TÜV SÜD - Healthcare & Medical Devices LinkedIn channel

How TÜV SÜD Can Help You with the IVDR

As one of the world’s largest EU Notified Bodies for all types of medical devices covered by EU directives and regulations, TÜV SÜD is designated as a full-scope Notified Body under the IVDR regulation.

Our experts’ experience and expertise make TÜV SÜD your trusted service provider for the certifications required to place your in-vitro diagnostic devices to the EU market, providing a full range of certification and testing services for global market access.

We work collaboratively with our partners to ensure access to critical innovative diagnostic technologies for patients and providers.

STRUCTURED DIALOGUE

The complex development process for most types of medical devices, combined with the need to address new regulatory requirements and obtain Notified Body approval, is likely to make the transition a complicated and time-consuming process for most device manufacturers. Further, previously approved devices are not exempt from the new regulation's requirements and will need to be re-evaluated and re-approved.

The purpose of a structured dialogue prior to lodging a formal IVDR application with TÜV SÜD is to clarify the timing, procedural, and regulatory aspects of the application process and forms, and the submission documents.

These structured dialogues are an opportunity to meet with us before the application for a conformity assessment and are independent of the assessment.

Expand the tabs below to find out the possible topics, process and how to apply for Structured Dialogue.

Get Started with TÜV SÜD

Request our services for your IVDR needs. Start your journey with us.      Request a reachout

ivdr application procedure

Based on the product classification, the manufacturer must apply for an applicable conformity assessment procedure.

Contact us using our simple service request form to initiate your application process.

Please note: TÜV SÜD Product Service GmbH does not provide conformity assessment services according to IVDR Annex X. At lodging of an application of IVDR Annex XI for class C and D devices, the manufacturer needs to provide a copy of the EU type-examination certificates issued by notified body designated for conformity assessment activities related to the types of devices concerned.

English and/or German are the only acceptable languages for the submission of documentation and any related correspondence.

Certification costs

The certification costs are based on hourly rates. They consider factors such as the size of company, number of sites, and number and complexity of devices.

TÜV SÜD Product Service GmbH takes into account the interests of SMEs by basing its entire fee structure mainly on effort-related criteria rather than fixed steps, thus enabling SMEs in particular for a precise and individual cost calculation based on the effort involved in each individual case.

The standard fees for the conformity assessment activities delivered by TÜV SÜD Product Service GmbH are as follows: 

*Depending on the location of the manufacturer and possibility to include local experts or auditors in the conformity assessment procedure, prices may vary, and fees may be invoiced in local currency.

IVDR resources

Ensure a smooth process of complying with the IVDR with the following resources.