Joint action of the Biomed Alliance and medical societies leads to delays in IVDR implementation

In June 2021 ESE alerted its members and the ECAS National Societies to the upcoming implementation of the In Vitro Diagnostics Medical Devices Regulation (IVDR). From May 26 2022 in vitro diagnostic tests would need to comply with this regulation, requiring a transformation of the diagnostics sector. This was considered impossible within the short timelines and would constitute a risk for disastrous consequences of diagnostic practices.

The Biomed Alliance IVDR Working Group worked with the Commission to address the implementation of the IVDR. As a result of this, the European Commission has now published a legislative proposal amending the IVDR and, more specifically, amending the transitional provisions for certain in vitro diagnostic devices and differing the application of requirement for in-house devices.

With the exception of the general safety and performance requirements for these devices, in-house devices are exempted from the IVDR, provided the health institution meets a number of the set out conditions. Among other things, health institutions must have an appropriate quality management system, comply with the international standard that sets out the quality and competence requirements for medical laboratories (EN ISO 15189) or other national provisions, and must justify that target patient group's specific needs cannot appropriately be met by an equivalent in vitro diagnostic medical device available on the market.     

Since the outbreak of the pandemic, many health institutions, in particular hospitals, have had to focus their efforts on dealing with COVID-19. The Commission therefore proposes to defer the application of most of the conditions to be met by health institutions making in-house devices by 2 years, until 26 May 2024. The requirement for the justification that there is no equivalent CE marked device available to meet the target patient group's specific needs is proposed to be deferred even further, until 26 May 2028, as the health institutions will need an overview of CE-marked in vitro diagnostic medical devices available on the market to comply with this requirement.

This revised legislative proposal is a major win for the health care sector, and testifies to the impact that concerted action of medical societies can have. Or, how policy and advocacy efforts can work.

We thank our members and affiliated societies for joining this effort.

Commission announces delays in IVDR implementation

The European Commission published a legislative proposal amending the in vitro Diagnostics Regulation (IVDR), and more specifically amending the transitional provisions for certain in vitro diagnostic devices and differing the application of requirement for in-house devices. The date of application of the IVDR remains on 26 May 2022 but the legislative amending act is extending several transitional provisions until 2028 depending on the scope of the devices and on a risk-based approach. Extended transitional periods are also provided for certain requirements for in-house devices. In order to clearly present you the amendments proposed by the Commission we made a short recap table.

What are the rules for ‘in-house devices'?
BioMed Alliance welcomes the publication of this proposal and we are working on a reaction. The legislative amending act was necessary to ensure proper IVDR implementation and to answer serious concerns from the diagnostic health community about the IVDR implementation status and the potentially disastrous consequences for diagnostic practice and patients’ safety in the European Union. However, we have some reservations regarding the provisions on in-house devices.

The next steps are that the European Parliament and the Council must adopt the proposal and the MDCG and the Commission will continue to work according to the Joint Implementation Plan. We are also carrying on our work and advocacy efforts to ensure necessary steps are taken, guidance documents will be published shortly and the Notified Body capacity will be increased.

‘In-house devices', also referred to as ‘laboratory-developed tests' are manufactured and used within the same health institution. They are not marketed or transferred to other legal entities and do not bear the CE marking. In-house devices developed in laboratories can be essential for the diagnosis and treatment, especially for rare diseases.

With the exception of the general safety and performance requirements laid down in Annex I of the IVD Regulation, in-house devices are exempted from the IVD Regulation, provided the health institution meets a number of conditions set out in Article 5(5) of the Regulation. Among other things, health institutions must have an appropriate quality management system, comply with the international standard setting out the quality and competence requirements for medical laboratories (EN ISO 15189) or other national provisions, and must justify that target patient group's specific needs cannot appropriately be met by an equivalent in vitro diagnostic medical device available on the market.     

Since the outbreak of the pandemic, many health institutions, in particular hospitals, have had to focus their efforts on dealing with COVID-19. The Commission therefore proposes to defer the application of most of the conditions to be met by health institutions making in-house devices by 2 years until 26 May 2024. The requirement for the justification that there is no equivalent CE marked device available to meet the target patient group's specific needs is proposed to be deferred even further, until 26 May 2028, as the health institutions will need an overview of CE-marked in vitro diagnostic medical devices available on the market to comply with this requirement.

Source: Q&A: New In Vitro Diagnostic Medical Devices Regulation (europa.eu)