The European Union’s (EU) In Vitro Diagnostic Regulation (IVDR) will replace the current Directive 98/79/EC on in vitro diagnostic medical devices from 26 May 2022. This new regulation will introduce substantial changes in the sector as companies in the IVD industry selling into the EU market will have to meet tougher medical device compliance requirements.
The regulation aims to ensure a high level of protection of public health, patients and users and the smooth functioning of the internal market considering the high number of small and medium-sized enterprises (SMEs) active in this sector.
Under this directive, all products of all classes that stay on the market after May 26 2022, must be reassessed for IVDR compliance to ensure that those products are fit for purpose and safe to use. There is no automatic pass granted based on the time that a product has been on the market i.e., no “grandfathering” is permitted. Notified Bodies and manufacturers must be prepared to market products in an environment now requiring greater control and oversight.
One of the main changes is to increase the involvement of independent conformity assessment bodies (‘notified bodies'). Currently, under Directive 98/79/EC, only a relatively small number of high-risk devices (about 8% of all in vitro diagnostics on the market) is subject to notified body control. Under the IVD Regulation, around 80% of in vitro diagnostic medical devices will be under the control of notified bodies, the vast majority of them for the first time.
The IVD Regulation also introduces a set of common rules for in-house devices, i.e. those that are manufactured and used in the same health institution. The new rules include requirements for justification for the use of these devices and rules to ensure their safety and performance, such as an appropriate quality management system.
Summary of key provisions included in the IVDR
Expanded product scope
More rigorous surveillance by NBs
Greater scrutiny of NBs
No device “grandfathering”
More rigorous clinical safety and performance evidence
More stringent technical file documentation
Implementation of unique device identification
Reduced general timeline reporting
Device reclassification according to risk
Increased post-market surveillance requirements
Pre-market approval of self-testing and near-patient testing devices
Identification of “person responsible for regulatory compliance”
What is IVDR?
The IVDR is a newly implemented regulatory component of the EU Regulation for medical devices (MDR). It replaces the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC) to help ensure the safety and efficacy of in vitro diagnostic devices available and in service in the European market.
While technically not a new regulation (it came into force back in May 2017) it has not yet been fully enacted. With most key components in place or in-process, May 26 2022, is the date after which all devices must be in compliance. However, products already certified by a Notified Body (NB) are allowed in the market until May 25 2024 under specific conditions and if the manufacturers fulfil particular prerequisites indicated in the IVDR.
Compared to the IVDD that it replaces, the IVDR promotes a shift from the pre-approval stage (i.e., the path to CE Marking) to a life-cycle approach. This is similar to the life-cycle view preferred by the US Food and Drug Administration and advanced by many international standards.
What is changing?
The biggest change is the introduction of a risk-based approach to classification in addition to increased NB oversight. The Regulation identifies four new risk classes: Class A (lowest risk), Class B, Class C, and Class D (highest risk) aligned with IMDRF/GHTF IVD classification guidance.
Under the current regulations, most IVDs are self-certify, thus a NB does not have to review the technical file. There are very few delays. With IVDR most IVD will not be self-certified and instead will fall into Class B, C, and D IVDs which will require NB intervention as part of their conformity assessment. Technical files and clinical evaluation reports that have been used for years. Medical device companies will need to be revised to meet the new regulations. This will also increase the strain on Notified Body resources, in addition to the extra work caused by the MDR.
What are some of the improvements?
- Clear obligations for economic operators (manufacturers, importers, distributors), such as traceability of devices, registration of devices and as economic operator (for manufacturers and importers), and verification of correct labelling.
- Introduction of a risk-based classification system with 4 risk classes of in vitro diagnostic medical devices: class A (low individual risk and low public health risk), class B (moderate individual risk and/or low public health risk), class C (high individual risk and/or moderate public health risk) and class D (high individual risk and high public health risk).
- Stricter control for high-risk in vitro diagnostic devices via a new pre-market scrutiny mechanism with a pool of experts at EU level.
- Reinforcement of the criteria for the designation and oversight of notified bodies* (a ‘notified body' is an independent third-party conformity assessment body) – more information below.
- Improved transparency through a comprehensive EU database on medical devices (EUDAMED), parts of which will be publicly accessible – more information below.
- A traceability system based on a unique device identifier (UDI).
- Reinforced rules on clinical evidence and performance evaluation, including an EU-wide coordinated procedure for authorising multi-centre performance studies.
- Strengthened post-market surveillance requirements for manufacturers.
- Improved coordination mechanisms between EU countries on vigilance and market surveillance.
- Specific regime for devices manufactured and used in the same health institution ('in-house devices').
Latest updates (as of January 10th 2022)
MedTech Europe has welcomed the adoption of the European Commission’s Proposal to amend the transitional provisions of the new EU IVD Regulation.
- It maintains the date of application of the IVD Regulation of 26 May 2022;
- It extends the transitional provisions for most IVDs already on the market, according to their risk class;
- It provides additional transition time for most of the requirements pursuant to in-house assays.
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), have a transition period until May 2025 and 2026, whilst lower risk ones such as class B and A sterile devices, have a transition period until May 2027.
The IVD Regulation introduces substantial changes in the regulatory framework for in vitro diagnostic medical devices, such as HIV tests, pregnancy tests or SARS-CoV-2 tests. Conformity assessment bodies (‘notified bodies') will play a more important role: they will independently monitor whether devices comply with the safety and performance requirements before they reach the EU market.
The IVD Regulation was planned to apply as from 26 May 2022. However, there is a serious shortage of notified body capacity, making it impossible for manufacturers to conduct the legally required conformity assessment procedures in time. Without any legislative action, there is a risk of significant disruption in the supply of various essential in vitro diagnostic medical devices on the market, affecting the diagnosis of patients and their access to relevant health care. Hence today's proposal to ensure a progressive roll-out of the IVDR.
No change is proposed for CE-marked devices that do not require notified body involvement under the IVD Regulation or for devices that are ‘new', i.e. devices that have neither a notified body certificate nor a declaration of conformity under the current Directive 98/79/EC. For those types of devices, the IVD Regulation will therefore apply from 26 May 2022 as planned.
Update on EUDAMED, Medical Devices Database
EUDAMED will provide an overview of all medical devices available in the European Union. It will be composed of six modules related to: actor registration, unique device identification (UDI) and device registration, notified bodies and certificates, clinical investigations and performance studies, vigilance and market surveillance. It will integrate different electronic systems with information about medical devices and related companies (e.g. manufacturers).
The development of EUDAMED is progressing, with first EUDAMED module on actor registration made available in December 2020. Since beginning of October 2021, the second and third modules are available, namely the module on UDI/device registration and the module on certificates and notified bodies, except for the mechanism for scrutiny and the clinical evaluation consultation procedure functionalities (CECP). The remaining modules as well as the functionalities for the mechanism for scrutiny and the CECP will be released when EUDAMED is fully functional.
Source: European Commission
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The main challenges for businesses are to identify gaps, streamline process and establish efficiencies both internally and externally review process to help avoid bottlenecks. We can support you to plan a regulatory strategy to be fully prepared.