24th March 2022
Digital health and MedTech companies are hearing a lot about the In-Vitro Diagnostics Regulation (IVDR) lately. As the deadline approaches for this new European regulation to come into force, many are still struggling to understand how this affects their business and the steps they should take to comply. This week’s blog provides an overview of IVDR and highlights the key changes to take action on before May 2022.
What is IVDR?
IVDR is the new regulatory basis for placing in-vitro diagnostic medical devices on the European market. The aim is to protect patients by effectively regulating medical devices’ quality, safety, and reliability. It will replace the EU’s current Directive on in-vitro diagnostic medical devices (98/79/EC) and will come into force officially in all EU member states, as well as Iceland, Liechtenstein, Norway and Switzerland, from 26th May 2022, having completed a five-year transition period.
Manufacturers and suppliers of IVDs will be obligated to supply further information on supply chain via a Unique Device Identification System, as well as comply with new standards for clinical evidence, managed via the European Databank of Medical Devices. Reporting and surveillance will also become standardised.
What types of companies does IVDR affect?
- In-vitro diagnostic manufacturers
- Digital health start-ups
- Software-as-a-medical device
- Internet of Medical Things
- AI & ML-as-a-Medical Device
Major changes can be categorised into device classification, notified bodies, and clinical evidence. These include:
- Expanded product scope now covering diagnostic services and genetic testing.
- Device classification: Devices will be reclassified according to risk, from Class A (low risk) to Class D (high risk). Regulation and assessment for each class of device will be tailored accordingly. Under the current Directive the majority IVDs for medical use with standalone algorithms only require a CE mark, which is self-assessed and usually positioned as ‘low risk.’ As part of the new changes, most IVDs that include algorithms, will move into ‘higher risk’ Classes (B, C and D).
- Notified bodies: As more devices become classified as higher risk, premarket approval will be required by designated Notified Bodies (nonsterile Class A is exempt). This represents a significant change in the system.
- Clinical evidence: Once a device is assigned a risk classification, manufacturers will need to conduct clinical performance studies and provide evidence of safety and performance. Requirements for performance evaluation of IVDs, clinical performance studies, and use of clinical data are defined in much greater detail in the new regulation.
Be aware that there are several other changes coming into effect, such as the requirement for a nominated regulatory compliance representative at each company, an increase in post market surveillance, and reduction reporting timelines. For in-house manufacturing of IVDs there will be additional requirements set out depending on each member state.
To meet the requirements effectively and ahead of May 26th, companies need to allocate sufficient time, resources and budget.
For a full overview and checklist on how to move forward with your compliance, join a free virtual masterclass EIT Health Ireland-UK is running in collaboration with regulatory consultants Med-Di-Dia next Tuesday 29th March from 1 – 3pm GMT. Learn directly from the experts by registering your place today.