In Vitro Diagnostics Medical Devices Regulation (IVDR) - setting the framework for the European IVD market

First IVDR certification for Roche Diagnostics

On 17 December, Roche announced that it has received its first “EU Quality Management System Certificate (IVDR)” from TÜV SÜD Product Service, one of its notified bodies under the new In Vitro Diagnostics Regulation (IVDR). The certification applies to more than 700 catalogue numbers of the Serum Work Area and Lab Coagulation portfolio. 

This “EU Quality Management System Certificate (IVDR)” is mandatory for any manufacturer of in vitro diagnostic devices (IVDs) to issue declarations of conformity for their products and to get them (re-)certified in compliance with the new regulation.

Our path to IVDR compliance

We are committed to managing the important transition from the In Vitro Diagnostics Directive (IVDD) to the In Vitro Diagnostics Regulation (IVDR) actively and in a timely manner. Meeting the regulatory requirements and our customers’ needs to ensure availability of our vital products to healthcare professionals and patients are our priorities. To achieve full IVDR compliance we are following a multi-stage approach: 

• We planned the IVDR transition of our CE-marked portfolio and allocated an adequate budget as well as the necessary resources to ensure that our ~2600 products (catalogue numbers) are IVDR-ready in time.
• In the preparation phase, we reviewed the Roche CE IVD portfolio and assigned a classification of our IVD portfolio. At the same time, we performed gap assessments (e. g. on clinical evidence). 
  
• Both of our notified bodies (TÜV SÜD Product Service GmbH and BSI Netherlands) were designated to assess IVDR conformity.
• Our first QMS audit and technical documentation reviews were passed in October 2020 without any non-conformities for a sample of over 700 catalogue numbers of the Serum Work Area (Clinical Chemistry and Elecsys) and Lab Coagulation portfolio. 
• We received our first "EU Quality Management System Certificate (IVDR)" for the respective QMS and product codes of this QMS audit.
  
• All other IVDR-relevant QMS systems are ready for notified body audit. However, due to travel bans during the ongoing COVID-19 pandemic, no physical audit is currently possible and these audits are on hold. Technical documentation reviews for the products falling under these QMS are currently ongoing.
  

While passing the QMS audits is a very important milestone, it does not mean that products will be directly available on the market. Product-specific reviews, approvals and Declarations of Conformity (DoC) will be required. Even though we will be able to guarantee IVDD-IVDR transition per product after a DoC is issued, it will still take several months for the IVDR product to actually be placed on the market. This is due to regulatory activities for the individual products that are triggered by IVDR label changes in many non-EU countries as well as production, supply-chain and logistics planning.

About IVDR

The new In Vitro Diagnostics Regulation (IVDR) entered into force on May 26th, 2017 to replace the existing In Vitro Diagnostics Directive.

What are the major changes in IVDR compared to IVDD?

• Risk classification of IVD devices
  
• Role of notified bodies
  
• Clarification of obligations of economic operators (manufacturers, authorised representatives, importers and distributors)
  
• Tightened requirements for post-market surveillance and vigilance
  
• Tightened requirements for clinical evidence and conformity assessment
  
• Introduction of a unique device identifier (UDI) for every IVD device
  
• Increased transparency, with information on IVD devices and ‘higher risk’ performance studies being made public in the new European Database for Medical Devices (EUDAMED)
  

Transition timeline

Requirements of the new regulation will fully apply on 26^th May, 2022. Devices lawfully placed on the market in accordance with IVDD (directive 98/79/EC) prior to the date of application by virtue of a valid certificate may continue to be made available on the market or put into service until 27^th May 2025 (Article 110 of the IVDR). This is possible only under the conditions that there are no significant changes in the design and intended purpose of the product. Certain post-market and registration requirements as per IVDR will apply.