The COVID-19 pandemic has put additional strain on the diagnostics industry in recent years, and has highlighted the importance of reliable, high-quality in vitro diagnostic (IVD) tests and raw materials.1 New European Commission regulations aim to reinforce the regulatory framework for IVD medical devices on the European market,2,3 so what does this mean for Medix Biochemica and our clients?
Medical devices, such as the instruments and reagents developed for in vitro diagnostic use,4 play an essential role in diagnosing, monitoring and preventing diseases – and saving lives.2 An estimated 70% of clinical decisions are made using IVD medical devices such as HIV tests and SARS-CoV-2 tests.2
The EU In Vitro Diagnostic Medical Devices Regulation (EU) 2017/7465a includes updates on manufacturer responsibilities and IVD medical device performance studies.2,3,5 It aims to enhance public health systems’ protection standards for patients and users while also supporting the smooth functioning of the internal market.2
How do regulatory changes affect Medix Biochemica and our partners?
The types of regulations we’ve discussed here are in place to ensure that all IVD testing materials on the market are safe and accurate, to avoid the risk of producing false-positive results.1
At Medix Biochemica, we pride ourselves on the safety and performance of our raw material products used in IVD tests.6 All our manufacturing sites follow strict quality-management systems and are ISO certified, so we can offer consistently excellent product quality.7
Through supplying our raw materials of highest quality, we’re committed to helping our customers meet the standards and requirements needed to comply with the new EU Regulation wherever relevant, and our industry-leading expertise enables our partners to get to market quickly with no compromise on quality.7
New IVD Regulatory Changes: The Basics
Here are some of the IVD regulatory updates currently being rolled out across the EU market:
More involvement from notified bodies
The Regulation will increase the involvement of the independent Notified Bodies responsible for assessing the conformity of IVD devices. Notified Bodies must be designated for IVDR conformity assessment and must have qualified staff in place to perform their conformity assessment tasks successfully. They also carry out onsite inspections of the manufacturers5. In the past, only high-risk IVD devices were assessed by Notified Bodies. Lower-risk IVD products now also require Notified Bodies' assessment.2
Performance claims to be supported by rigorous evidence
Manufacturers must support their claims about the performance of an IVD device with rigorous evidence, which includes analytical and clinical performance data.5
- If a performance study is conducted in multiple EU Member States, it will be subject to a coordinated assessment5
- This also applies to performance studies conducted in non-EU countries, but using specimens from EU patients5
More stringent manufacturers' obligations
Manufacturers now have more stringent obligations when it comes to monitoring their devices for performance, quality and safety.5 Measures must be in place that are appropriate for the type and risk level of the IVD device itself, as well as the size of the manufacturing company.
Manufacturers must also have sufficient financial means to cover their potential liability, quality management and post-market surveillance systems.5
Tightening the rules around high-risk devices
Class D (high-risk) devices are those designed to detect transmissible agents in the blood, cells or tissues, including agents that can cause a life-threatening disease.5,8,8a These devices may also be used to determine the infectious load of a life-threatening disease.8,8a
The new Regulation has tightened the rules around these devices:5
When a new class D device is being certified and no common specifications are available, an expert panel must provide its views on the device’s performance. The notified body isn’t bound by the panel's views, but must provide a justification if they choose not to follow them
Designated EU reference laboratories must test class D devices for performance, to make sure they meet the manufacturer’s claims. The notified body cannot deliver the certificate for the device without approval from the designated laboratory
Managing the patient end of generic testing
Patients who receive a genetic test must be given all the information they need about the significance and implications of the test.5 In cases where a test is designed to find a genetic predisposition for an untreatable condition, these patients must also get appropriate access to counselling.5
Supporting incident and suspected incident reporting
Manufacturers are already required to report both serious incidents (i.e. those that result in death or serious deterioration in health) and trends in side effects caused by their IVD medical devices.5 The new Regulation makes it easier for Member States to support healthcare professionals, users and patients in reporting suspected incidents as well.5
Ensuring comprehensive market surveillance
The relevant authorities and manufacturers in EU Member States are responsible for checking that IVD devices sold there comply with the Regulation and don’t endanger the wellbeing of patients or users.5
Development of EUDAMED
EUDAMED has put a system in place for registering IVD devices and a Unique Device Identifier (UDl) is assigned to each one to ensure traceability at each stage of the supply chain.5 This means that, if a problem arises, the appropriate measures can be taken quickly.5
The IVD regulation roll-out timeline
In October 2021, the European Commission proposed a staggered roll-out of the new regulatory measures, to prevent disruptions in the supply of essential healthcare products.2
Since May 2022, companies have been required to comply with IVDR, however due to a shortage of Notified Bodies, the required assessment of the products has been postponed in the following classifications:3,5
High-risk (class D) IVD devices such as those used for HIV or hepatitis tests5
26 May 2025
Class C IVD devices such as those used for certain influenza tests5
26 May 2026
Lower-risk IVD devices such as class B and class A sterile devices5
26 May 2027
Certain provisions concerning devices manufactured and used in health institutions3
26 May 2028
How can Medix Biochemica help IVD customers ease into the notified bodies assessment process?
At Medix Biochemica we provide a customer-centric approach and tailored services that set us apart from the competition.9 Performance and quality are at the heart of what we offer.6,7 Our scientific professionals bring decades of IVD expertise to the table and one in five employees is dedicated to developing new products.9 That’s how we stay at the cutting-edge of all aspects of the industry.9
- Scientifically-justified products
- Informed answers to any scientific questions our customers may have and which their Notified Body may question during an assessment (for example, the cross-reactivity of certain antibodies)
- Rapid response time for these customer questions
- Excellent capabilities for further analysis of any products, should a Notified Body raise any concerns
- Assessment of our raw material suppliers, to ensure consistent quality and sustainability
(Read the EU’s Company Sustainability Reporting Directive here11)
- Excellent lot-to-lot consistency built into our product manufacturing processes
In our partnerships with IVD test suppliers, we offer all of the above and more to ensure that our products effectively assist in meeting all regulatory requirements.
To discuss your needs with one of our experts, please get in touch today.
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References:1. Expert opinion. Medix Biochemica. November 2022
2. European Commission. Public health: Commission proposes a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation. 2021. Accessed February 9, 2023. https://cyprus.representation.ec.europa.eu/news/public-health-commission-proposes-progressive-roll-out-new-vitro-diagnostic-medical-devices-2021-10-14_en.
3. European Commission. Questions and answers: Commission proposes an extension of the transitional periods for the application of the Medical Devices Regulation. 2023. Accessed February 9, 2023. https://ec.europa.eu/commission/presscorner/detail/en/qanda_23_24.
4. Medical devices. World Health Organization. Accessed February 9, 2023. https://www.who.int/health-topics/medical-devices.
5. Summary: Regulation (EU) 2017/746 on in vitro diagnostic medical devices. EUR-Lex. Accessed February 9, 2023. https://eur-lex.europa.eu/EN/legal-content/summary/ensuring-the-safety-and-performance-of-in-vitro-diagnostic-medical-devices.html.
5a. Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in Vitro Diagnostic Medical Devices and Repealing Directive 98/79/EC and Commission Decision 2010/227/EU. 2022. Accessed February 28, 2023. http://data.europa.eu/eli/reg/2017/746/2022-01-28/eng.
6. Sustainability. Medix Biochemica. Accessed February 13, 2023. https://www.medixbiochemica.com/sustainability.
7. What we IVDo. Medix Biochemica. Accessed February 13, 2023. https://www.medixbiochemica.com/what-we-ivdo
8. Annex VIII (IVDR): Classification rules - medical device regulation. In Vitro Diagnostic Medical Devices Directive. Accessed February 9, 2023. https://de-mdr-ivdr.tuvsud.com/Annex-VIII-Classification-rules-IVDR.html.
8a. Guidance on Classification Rules for in-vitro Diagnostic Medical Devices for Regulation (EU) 2017/746. Medical Device Coordination Group. February 2023.
9. Our R&D capabilities. Medix Biochemica. Accessed February 9, 2023. https://www.medixbiochemica.com/research-and-development.
10. Expert opinion. Medix Biochemica. April 2023.
11. Directive (EU) 2022/2464 of the European Parliament and of the Council of 14 December 2022 Amending Regulation (Eu) No 537/2014, Directive 2004/109/EC, Directive 2006/43/EC and Directive 2013/34/EU, as Regards Corporate Sustainability Reporting (Text with EEA Relevance). Vol 322.; 2022. Accessed May 4, 2023. http://data.europa.eu/eli/dir/2022/2464/oj/eng.