Progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation

in vitro diagnostic medical devices

On October 14th, 2021 European Commission proposed a progressive roll-out of the new in vitro diagnostic medical devices regulation. In this way, disruptions in the supply of these essencial sanitary products could be avoided.

Indeed, in the last period member States, health institutions and economic operators were forced to divert resources to address the Covid-19 pandemic crisis. As a consequence, their capacity to comply on time with the changes introduces has diminished.

Stella Kyriakides, Commissioner for Health and Food Safety, said:

The COVID-19 pandemic has shown how essential it is to have accurate diagnostics and a robust regulatory framework for in vitro medical devices. Shortages at this point in time are unthinkable. The pandemic has imposed unprecedented challenges also for our medical devices industry. With more time to prepare for the application of the EU new rules, we will ensure there is a continuous supply of essential in vitro diagnostic medical devices on the market, while not compromising on safety. I call on all manufacturers to prepare for certification under the new Regulation as soon as possible and not wait until the end of the transition period.

In Vitro Diagnostic Medical Devices Regulation (IVD regulation)

EU 2017/746 Regulation (IVD regulation) introduces substancial changes to the regulatory framework for the in vitro diagnostic medical devices, such as:

  • HIV test;
  • pregnancy test;
  • SARS-CoV-2 test.

The new IVD regulation will replace the current directive 98/79/CE.

The regulatory aims to guarantee a high level of protection of public health, patients and users. It also will ensure the proper functioning of the internal market, by taking into account the high number of small and medium-sized enterprises in the sector.

Conformity assessment bodies (‘notified bodies‘) will play an important role. They will independently monitor whether devices comply with the safety and performance requirements before they reach the EU market.

At the moment, actually, only 8% of all in vitro medical and diagnostic devices on the market is subject to control by notified bodies in accordance to the directive 98/79/CE. Under the IVD regulatory, on the contrary, approximately 80% of in vitro medical and diagnostic devices will be controlled by notified bodies. For most of them it will happen for the first time.

The IVD regulatory introduces also common rules for in-house devices (devices that are produced and used whithin the same health institution). Among these rules there are instructions about:

  • justification of use of in-house devices,
  • safety and performance (for this purpose is introduced also an adequate quality management system).

Issues related to IVD regulatory application

The IVD regulation was planned to apply as from 26 May 2022. However, there is a serious shortage of notified body capacity. It makes it impossible for manufacturers to conduct in time the legally required conformity assessment procedures.

Without any legislative action, there would be a risk of disruption in the supply of various essential in vitro diagnostic medical devices on the market, that would definitely affect the diagnosis of patients and their access to health care. Hence the proposal, published on October 14th, to ensure a progressive roll-out of the IVDR.

Proposal of a progressive roll-out of the new in vitro diagnostic medical devices regulation

In a letter dated11 May 2021, the European Parliament called on the Commission to submit a legislative proposal to ensure a smooth transition to the new regulatory framework. That would ensure also the availability of in vitro diagnostic medical devices on the EU market. Calls for urgent action came as well from stakeholders representing healthcare professionals, medical device industry, clinical laboratories, notified bodies, and not-for-profit blood establishments.

The proposal does not change in substance any requirements of the In Vitro Diagnostic (IVD) Regulation. It only makes some changes to the transitional provisions, in order to allow the Regulation’s progressive rollout.

The length of the proposed transition periods depends on the type of device:

  • higher risk devices, such as HIV or hepatitis tests (class D) and certain influenza tests (class C), the transition period lasts until May 2025 and 2026;
  • lower risk devices, such as class B and class A sterile devices, have a transition period until May 2027.

The Commission also proposes a deferred application of the requirements for in-house devices. Instead, no change is proposed for other devices, for which the IVD Regulation will apply from 26 May 2022 as planned. Among them there are:

  • CE-marked devices that do not require notified body involvement under the IVD Regulation;
  • ‘new’ devices, i.e. devices that have neither a notified body certificate nor a declaration of conformity under the current Directive 98/79/EC.

The Proposal of a progressive roll-out of the new in vitro diagnostic medical devices regulation will now go to the European Parliament and Council for adoption.

The European regulatory framework related to medical devices

In the EU medical devices are governed by EU regulation 2017/745 on medical devices and by the following directives:

On April 5th, 2017 were adopted also two new regulations on medical devices and on in vitro diagnostic medical devices:

  • Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
  • Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU.

These regulations came into effect on May 25th 2017 and will progressively replace the current directives.