Preparing for the EU IVDR Regulation Changes: Advice for IVD Manufacturers

In vitro diagnostic medical devices, refer to tests used on biological samples to assess an individual’s health. From a lateral-flow test for COVID-19, to a sophisticated diagnosis performed in a clinical laboratory, these diagnostic essentials play a pivotal role in the wider sphere of medicine, facilitating 70% of clinical decisions. 

As innovative new devices continue to emerge, regulations in the EU are adapting to preserve patient safety and device accuracy. Without the right regulatory preparedness, IVD organisations will risk losing access to EU markets. To maintain competitivity in a wider market, global IVD organisations seeking to place products within the EU face growing pressures to stay up-to-date, driving a growing need for specialist regulatory support to streamline change fast. 

Read on to find out:

• What is the IVDR (In Vitro Diagnostic Medical Devices Regulation)
• Do IVD regulations apply in the UK?
• Is there an IVDR transition period?
• Where to find further guidance

What is IVDR?

IVDR stands for In Vitro Diagnostic Medical Devices Regulation and was first announced by the EU in 2017, and has applied to EU Member states and Northern Ireland since the 26th of May 2022.

The IVDR has replaced previous directives (Directive 98/79/EC) on IVDs and introduced substantial changes to the sector. At its core, the regulations aim to ensure both a high level of public health, patient, and user protection, while also ensuring the smooth functioning of the wider internal market including small and medium size medical device organisations.

Among the changes implemented by the IVDR, increased involvement of independent conformity assessment bodies, also known as notified bodies, poses a potential bottleneck on implementation for many organisations. Prior to the regulations, merely 8% of all IVDs on the market were assessed by notified bodies. Under the IVDR however, around 80% of IVDs will be subject to notified body assessment and control. 

This is challenging as there are merely 6 notified bodies designated under the IVDR so far, meaning that manufacturers face uncertain timelines for conducting the legally required conformity assessment procedures.

Other significant IVDR changes include:

• In-house devices common rules and specific regimes.
• Clear obligations for economic operators to ensure traceability, registration, and verification.
• Introduction of a risk-based classification system with 4 risk classes of in vitro medical devices (Class A: low risk, Class B: moderate risk, Class C: high risk, and Class D: high risk).
• Stricter control for high-risk IVDs through a new pre-market scrutiny mechanism.
• Improved transparency via EU medical device database EUDAMED.
• Reinforced rules on clinical evidence and performance evaluation.
• Strengthened post-market surveillance requirements.
• Improved coordination mechanisms between EU countries on market surveillance and vigilance.

Do the IVD regulations apply to the UK?

Following both the UK’s departure from the EU and the end of the transition period on 31st December 2020, the IVD regulations do not apply to Great Britain (England, Scotland and Wales).

Great Britain will instead continue to adhere to the Medical Devices Regulations 2002 in place of the IVDR. The British government has however introduced secondary legislation since January 2021 for medical devices. 

The main changes include:

• The creation of the UKCA route for manufacturers outside of Great Britain seeking to place medical devices on the Great Britain market.
• Compulsory MHRA registration for all medical devices prior to placement on the Great Britain market.
• Non-Great-Britain-based manufacturers will need a UK Responsible Person to carry out tasks including registration.
• Continued recognition of EU CE marking until the 1st of July 2023.
• Continued recognition of EU-recognised notified bodies certificates until the 30th of June 2023.

In Northern Ireland however, the rules for medical devices, including IVD’s align to EU regulations. This means that the EU IVDR has applied in Northern Ireland since the 26th of May 2022. 

Is there an IVDR transition period?

The IVD regulations were drafted prior to the pandemic, where ensuing disruptions diverted resources to address immediate global health concerns. In recognition of this, the EU have introduced transitional provisions to allow a progressive rollout of the IVDR. 

Stella Kyriakides, EU Commissioner for Health and Food Safety, said, “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”. 

Despite the provisions made, Kyriakides implores manufacturers to prepare for and prioritise regulatory action, “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”. 

It’s notable that the transitional provisions do not change any requirements of the IVDR, and that the length of transition periods depend on the risk class of the IVD, and prior notified body certification.

Article 110 of the IVDR details a transitional period lasting until 26th of May 2024 for IVDs with certifications from notified bodies in accordance with the Directive on IVDs prior to May 2022. 
The transitional period has since been extended by 1 year, until May 2025.

This transitional period will only affect those devices that require a notified body certificate operating under the previous directive (only 8% of IVDs in total).

Meanwhile, high-risk Class D devices will have a transition period until May 2025, high-risk Class C devices will have a transition period until May 2026, and low-risk Class B and Class A devices will have a transition period until May 2027.

This transition structure has been implemented to help mitigate the shortage of notified bodies in the EU while maintaining a high level of public health protection.

It’s notable that the transition period does not change any requirements of the IVDR in substance, meaning that the general application date of the Regulation remains 26th of May 2022. The IVDR has applied in full since 26th of May 2022 to CE marked IVDs that do not require the involvement of a notified body; including Class A non-sterile devices, and new IVDs not covered by a certificate, or a manufacturer’s declaration of conformity issued before the 26th of May 2022.

The additional transitional periods can only be used provided manufacturers can satisfy certain conditions, including continued compliance with the Directive, and an absence of significant changes to design and intended purpose.

Resources and guidance 

• Oxford Global Guidance to understand your device’s class, and whether it falls under EU MDR or EU IVDR 
• Q&A on the progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation 
• Q&A on the interface between EU Regulation 536/2014 on clinical trials for medicinal products for human use and Regulation 2017/746 on IVDR 
• Application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC 
• Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR 
• MHRA guidance for Northern Ireland implementation of EU MDR and EU IVDR 
• Great Britain Guidance for in vitro diagnostics regulations

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