The EU In Vitro Diagnostics Regulation (IVDR), written in 2017, was developed to replace the existing EU In Vitro Diagnostics Directive (IVDD). It’s been subject to a number of delays but the IVDR is now slated to come into force on 26th May 2022. What are the key changes you need to be aware of?
For various reasons, the IVDR has been subject to considerable delays in coming into force across the European Union. First there was a lack of Notified Bodies qualified to certify products against the requirements, then Covid struck and a further extension was announced. But it is now (practically) certain the IVDR will now come into force in May 2022. Are you ready?
IVDR will come into force in May 2022 (almost certainly)
There have been so many delays around the implementation of first the MDR (Medical Device Regulation) and then the IVDR, that manufacturers may be forgiven for feeling sceptical about the certainty of that date. Indeed, many in the industry are still campaigning for a further extension to the deadline. And this, together with the uncertainty about the exact nature of the post-Brexit IVDR regulation, may be making UK developers feel cavalier about dates and deadlines in general.
However, for those wanting to trade in Europe post May 2022, time is really running out to bring your quality management system and product into compliance.
What is the IVDR?
The IVDR represents a considerable increase in regulatory requirements that reflect the huge advances in technology and elevated risk for consumers that have come about since the IVDD was originally almost written 20 years ago.
There is now more self-testing and near-patient testing going on, more digital tech involved, more complexity and more automation in laboratories. IVDs are being used by different people in different settings and combining them with medical devices to self-guide treatment (often with minimal clinical intervention).
Following the huge success of COVID-19 testing in recent months, we are also seeing a surge in interest in the sector. This is creating competitive and price pressures that will, in turn, increase the need for regulation to ensure quality standards don't suffer.
Luckily, this is exactly what the IVDR is intended to deliver on, through its expanded scope.
The IVDR is a big deal for manufacturers
The new regulation runs to nearly 90,000 words compared to the 20,000 of the IVDD. The IVDR has 113 articles compared to the 24 of the previous iteration.
More devices must now be fully reviewed by notified bodies. Devices that once fell into regulatory grey areas are now in scope. In addition, more clinical evidence and post-market surveillance is required, as well as new UDI and labelling requirements to be adhered to.
If you have an existing product that is compliant under the IVDD and you haven’t started to prepare for the change, there is a lot to do. And if you think your product does not come under the definition of an IVD device or require a QMS, then you should double check the regulation, because you may have some serious ‘reverse engineering’ to do.
Are you ready for the EU IVDR? 9 things you need to know
- The IVDR uses a new risk-based rules classification scheme putting devices into new Classes A, B, C, and D (see Chapter V & Annex VIII) that reflect the MDR. This new system now requires 80 - 90% of IVD devices sold in Europe to be reviewed and certified by a Notified Body. Compare this to the 10-20% of devices currently in scope under the IVDD.
- Class B, C, and D manufacturers will be required to have a quality management system and undergo a technical documentation review. They will also be exposed to unannounced Notified Body audits (Annexes II, III, IX, X, XI).
- There are no provisions for grandfathering devices. All moderate and high-risk IVDs, whether compliant under the IVDD or not, must be certified to meet the IVDR by May 2022. Low risk IVDs have until May 2024 but still must meet IVDR QMS requirements.
- Software as part of IVD instruments, SaMD (Software as a Medical Device), and apps are now included in the definition of IVDs and will be subject to the IVDR.
- There is new oversight of single-use IVDs, companion diagnostics (CDx), and genetic tests.
- There are more requirements for clinical evidence and performance studies (Chapter VI & Annexes II, XIII, XIV).
- Vigilance and post-market surveillance requirements have been greatly increased (Chapter VII & Annex III). Technical documentation will need to detail the post-market surveillance system (PMS) that the manufacturer will have in place to continually monitor and assess the safety and effectiveness of the IVD in actual use.
- There is a new focus on labeling identification and Unique Device Identification (UDI) product traceability. UDIs will need to be introduced by 2023 for Class D; 2025 for Classes C and B; 2027 for Class A). See Articles 24-27.
- There are new responsibilities for ‘economic operators’ involved in the sale and distribution of IVDs in the EU. Manufacturers must appoint an EU-based Authorized Representative (if physically located outside the EU), an importer and a Person Responsible for Regulatory Compliance (PRRC). Importers and Distributors have certain new quality management responsibilities that they need to document and be accountable for - and it’s up to manufacturers to ensure they do.
IVD manufacturers in the UK have a lot of regulation to think about right now. You should already have registered with the MHRA to legally sell your product in post-Brexit Britain, even though the exact nature of the regulation you’ll be required to comply with is currently a mystery.
But the EU IVDR is a real and looming presence in the regulatory landscape. The timelines are real, the regulation is well documented, and notified bodies are ready(ish). It’s now up to you to ensure you can meet the new QMS and other requirements if you want to continue trading when the balloon goes up.