How is the IVDR structured?
What else is new?
Is there a new conformity assessment procedure?
What stricter standards does the IVDR impose?
How should manufacturers prepare for the IVDR?
Are there transition periods?
How likely is it that the transition periods will be extended?
What should manufacturers expect if the transition periods are not extended?

Similar to the EU Regulation on Medical Devices (for further details, please see "One year to go: Q&A on EU Medical Devices Regulation"), the EU In Vitro Diagnostics Regulation (IVDR)(1) entered into force on 25 May 2017 and will fully apply from 26 May 2022. This article focuses on important questions and the main changes that the new regulation brings.

How is the IVDR structured?

The IVDR contains 113 articles, far more than the 24 articles of the EU In Vitro Diagnostics Directive (IVDD).(2) This increased extent is due to the regulation's coverage of nearly every aspect relating to in vitro diagnostics (IVD), the broadening of the scope of IVD products and the fact that the regulation addresses producers and distributors as well as operators and competent public authorities. In light of this, the European Commission recently published Q&As on the IVDR.

Whereas products are still classified into different categories and manufacturers have to establish through a conformity assessment procedure that all regulatory requirements are met, the process has been changed. For example, instead of two lists and "other IVD-products", devices are now categorised into classes A to D according to Annex VIII of the IVDR, based on the product's risk. Additionally, products are divided into products for self-testing, near-patient testing and companion diagnostics.

This reclassification results in a radical change with severe consequences:

  • The conformity assessment procedure for class A (the lowest risk class) devices remains the responsibility of the manufacturers (via a self-declaration of conformity). However, under the previous IVDD, 80-90% of all IVDs could be placed on the market following this approach (all so-called "other IVD-products" – that is, devices not listed in the two lists provided by the IVDD). Under the IVDR, it is assumed that only 10-20% of IVDs will be classified as class A. Class B, C, D devices require the involvement of a notified body to carry out the conformity assessment procedure.
  • In addition, there are no "grandfathering" provisions, meaning that all IVD devices will need a certificate of conformity under the IVDR, even if they have been approved under the IVDD.

What else is new?

Common specifications
Another major new feature is the so-called "common specifications", which can be imposed on manufacturers as additional harmonised standards for products to fulfil. The European Commission is authorised to pose such new requirements without parliamentary participation. This has been criticised by experts, who believe that standardisation bodies or expert panels would be more suited for this task. So far, no common specifications have been adopted; however, the European Commission is currently establishing those for 16 different IVD types.

Further, IVD products, like other medical devices, must now be identified using a unique device identification (UDI) and registered with the database EUDAMED. The EUDAMED database will include six modules referring to different aspects of each registered device. Although its establishment has not been completed, it is expected to be fully developed on time.

Compliance officer
Another new feature is the introduction of a so-called "compliance officer". According to the new provisions, all device manufacturers must designate one person within the organisation that will be responsible for its compliance with the regulation.

In-house or laboratory-developed devices
In-house or laboratory-developed devices, which are products that are manufactured and used within the same institution, will not be subject to the regulation's provisions, provided that they meet general safety and performance requirements.

Is there a new conformity assessment procedure?

The number of assessment procedures from which manufacturers can choose has been reduced to three:

  • Class A products can be approved by providing the technical documentation for the product and for the post-market surveillance without the involvement of a notified body.
  • Class B products must pass a conformity assessment based on a quality management system and on an assessment of the technical documentation of a product representing the product category.
  • Class A sterile (As), C and D manufacturers can choose between the aforementioned process (quality management system plus technical documentation of a product representing the product group (for class C), or of the product itself (class D)), and the conformity assessment based on type-examination plus production quality assurance. In addition, class D products may have to undergo an examination by a reference laboratory or an expert panel.

What stricter standards does the IVDR impose?

Quality management system
A new requirement imposed on every IVD device manufacturer, even manufacturers of class A products, is the obligation to provide their own quality management system. If the product conformity assessment is based on production quality assurance or on a quality management system, the manufacturer must have their system certified by a notified body. The requirements to be met by the quality management system are broad and include the manufacturing organisation, processes, responsibilities, resource management, risk management, development, production, maintenance and market surveillance. Quality management systems shall be unannouncedly checked by a notified body at least every five years.

Technical documentation
Requirements concerning technical documentation have become stricter as well. Performance data must include, among other things, analytical sensitivity, accuracy and measurement details. Also, requirements regarding clinical trials have become extensive and specific compared with the previous provisions. The same applies to provisions concerning post-market surveillance.

The requirements for a product's labelling, specifically its instructions for use, warnings and other indications have been significantly extended.

Provisions regarding software have also become stricter and more extensive compared with the IVDD. Software must be included in risk management and, among other requirements, secured against unauthorised access. It also needs to be identifiable through a UDI.

Notified bodies
The criteria for the designation and supervision of notified bodies have been tightened compared with those under the IVDD. Besides that, they will be increasingly involved in the conformity assessment procedure of IVD devices, as class B, C and D devices will be subjected to their review. As a result, approximately 80-90% – compared with the previous 10-20% – of IVD devices will need a notified body's involvement.

How should manufacturers prepare for the IVDR?

Manufacturers should:

  • already have re-assessed their products' classification in order to prepare for the necessary conformity assessment process;
  • ensure that their quality management system complies with the new standards and implement changes if necessary; and
  • work on their UDI strategy as well as on reassessing their technical documentation and post-market surveillance system in order to comply with the IVDR.

Further, coordinating steps and timelines with the responsible notified body is of crucial importance.

Are there transition periods?

The date of application of the IVDR remains the 26 May 2022, leading to a termination of many currently valid declarations of conformity. However, on 14 October 2021 the European Commission, referring to the difficult circumstances caused by the covid-19 pandemic, issued a suggestion that could provide manufacturers with more time to prove the IVDR conformity of their products:

  • According to the suggested changes, certain conformity declarations that were issued according to Annex VI of the IVDD or after 25 May 2017 would be extended for one year, meaning that they would remain valid until 27 May 2025.
  • Further, products that were declared to conform without the participation of a notified body under the IVDD and will now have to pass a conformity assessment procedure could have their transition periods extended until 2027, 2026 and 2025 for classes As/B, C or D, respectively, provided their design and purpose is not altered significantly.
  • Products that are manufactured and used by medical institutions may also benefit from prolonged transition periods.

Not included within the suggested extension are non-sterile class A products and new IVD devices. As the regulation will nonetheless be in force from 26 May 2022, all IVD devices must comply with all other provisions (eg, regarding vigilance and market surveillance).

How likely is it that the transition periods will be extended?

Currently, it is difficult to predict whether the transition periods will be extended as the European Parliament and the European Council have yet to adopt the suggestion. It is therefore strongly recommended for manufacturers to not rely on the possibility and continue to prepare for the new regulation in a timely manner. However, it is now even more important for manufacturers to reassess the classification of their own products, as the implementation of the European Commission's suggestion would influence the transition periods depending on a product's classification.

What should manufacturers expect if the transition periods are not extended?

Experts have recently been warning that an unmodified enforcement of the IVDR could lead to a drastic shortage of available IVD products, which would pose an immense threat to patient safety. Due to the new stricter criteria for notified body designation and the expansion of to-be-approved products, the currently low number of notified bodies will not be able to process all certification requests.

It is estimated that as of 26 May 2022, at best only 60% of products will have obtained their certificate of conformity. All the more, an extension of the transition periods would be helpful.

For further information on this topic please contact Magdalena Kotyrba-Hagenmaier or Tobias Maier at Eversheds Sutherland LLP by telephone (+49 89 54565 0) or email ([email protected] or [email protected]). The Eversheds Sutherland LLP website can be accessed at


(1) 2017/746/EU.

(2) 98/79/EC.