Understanding EU MDR and IVDR: Essential Compliance Steps for 2024

Significant changes have been made to the compliance landscape due to the Medical Device Regulation (MDR) of the European Union and In Vitro Diagnostic Regulations (IVDR). This has an impact on medical device manufacturers that trying to access the EU market. The purpose is to improve safety and transparency and enhance the industry by mandating strict requirements on the manufacturers. Both frameworks exhibit impeccable safety, quality, and market access proposals and the up-dation has been applicable since 2021 for MDR while in the case of IVDR, it started a bit later from the year 2022. This guide will highlight the key compliance obligations and deadlines for manufacturers to consider as they continue to make sense of these complex regulations.

Understanding EU MDR and IVDR Compliance Requirements

The EU MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation) are two important regulations that assert certain control over how medical devices are made and sold and adhere to compliance in the European Union. This regulation will replace the current Medical Device Directive and also covers all medical devices that directly interact with the human body – from bandages to implants to diagnostic tools. On the other hand, IVDR concerns in vitro diagnostic (IVD) medical devices like blood tests and COVID-19 kits that take samples externally.

Although the MDR and IVDR share structural similarities, they deviate widely in scope and requirements. MDR is somewhat broader with 123 articles compared to IVDR's 113, due in part to category-specific thresholds and substance lists. However, both regulations address patient safety, performance, and transparency for bringing a device to the market within the EU.

The MDR requires a clinical evaluation report for pre-market compliance, while the IVDR mandates performance evaluations and studies of IVD devices. MDR and IVDR also have different post-market obligations, with MDR prescribing continuous clinical follow-up while the requirement for IVDR is to perform Post-Market Surveillance (PMS) and vigilance.

MDR and IVDR Deadlines for Legacy Devices

Under older directives, both MDR and IVDR are certified for transitional provisions of legacy devices. Deadlines are extended according to the class of the device allowing manufacturers to meet compliance standards. For instance, under MDR, certain Class III and IIb are implantable devices in the market until December 31, 2027. Class D devices have time until May 2025 under IVDR whereas Class B, as well as sterile Class A, have May 2027. These extensions help ease the transition to market but will keep making the safety of patients secure.

Restrictions under REACH and CLP

Both MDR and IVDR require compliance with REACH and CLP regulations to manage substances of high concern (SVHC) in devices. Manufacturers must provide users with information on safe handling and potential risks if SVHC exceeds 0.1% weight-by-weight. Moreover, to promote safe usage and handling within the healthcare setting, CLP mandates clear labeling for hazardous chemicals.

Essential Compliance Steps for 2024

To meet EU MDR and IVDR compliance requirements, there are certain steps that help guide manufacturers:

1. Device Classification and Conformity Assessment

·   Certification will require Notified Body involvement for higher-risk devices. To prevent delays due to capacity constraints early engagement with a Notified Body can help.

·   The updated classification of your device under MDR and IVDR is determined.

2. Technical Documentation

·   Comprehensive technical documentation is required to cover aspects like design, risk analysis, intended use, and performance evaluation.

·   Make sure that all the documentation is up-to-date demonstrating compliance with clinical safety and essential requirements.

3. Conduct Clinical or Performance Evaluation

·   MDR and IVDR both have provisions that clinical and performance evaluation is a part of the conformity assessment.

·   Clinical data shall substantiate the performance, safety, and effectiveness of a device under consideration. It must be under constant observation, including regular updates based on post-market information.

4. Post-Market Surveillance Plan Implementation (PMS)

·   It should also develop and maintain a strong PMS plan for continuous performance monitoring and safety of the devices. It should, among other things, include vigilance reporting of adverse events and proactive risk management.

·   It should make its QMS adaptable to post-marketing surveillance, which under MDR will be well represented by comprehensive PMS measures.

5. Prepare for EUDAMED Registration

·   Register device and company information in the EUDAMED database; all documents and labels for the device must comply with the regulations on the data requirement of EUDAMED.

·   Assign a UDI for traceability. Most devices are required to have traceability under MDR and IVDR.

6. Labeling and Packaging Compliance

·   The labels should update to reflect all requirements of MDR and IVDR including the UDI and other information relevant for end-users, to be transparent, accurate, and potentially in more languages than one depending upon the area.

·   Packaging would also be aligned with those compliance requirements by ensuring that the products are safe to use and for the environment when it is needed.

7. Engage with a Notified Body Early

·   These bodies authorize most of the high-risk devices. The availability of very few designated Notified Bodies raises a concern in terms of capacity.

·   Even participation in the process from the planning stage will improve the degree of certainty about the desired compliance much faster and avoid bottlenecks close to deadlines.

Challenges and Considerations for 2024 Compliance

1. Capacity Limitation from Notified Bodies: When the demand for Notified Body certification is rising, the limit in capacity is a concern. Delays may occur and so manufacturers need to plan ahead. Sufficient time during the reviews by the Notified Body is therefore a buffer against any delay in having their products certified well in time before hitting the market.

2. Managing Ongoing Compliance Needs: MDR and IVDR have enhanced post-market surveillance to unprecedented levels through intensive monitoring and swift response to the available safety data. Companies can build teams with in-house specializations or outsource these functions to maintain continuous compliance with reporting standards. This ensures that companies meet regulatory demands and facilitate further enhancement of product safety.

3. Resource Allocation and Cost Management: MDR and IVDR are highly resource-intensive. Investment in clinical studies, documentation, and post-market monitoring is required. Sustainable compliance efforts should be facilitated by effective resource allocation and strategic budget planning. By managing costs effectively for the companies, companies can balance the high demands of compliance with operational sustainability, making compliance a feasible long-term goal.

References

1.   DistillerSR Inc. (2023b, November 13). What Is the Difference Between MDR and IVDR - DistillerSR. Retrieved from https://www.distillersr.com/resources/meddev-literature-review/what-is-the-difference-between-mdr-and-ivdr#:~:text=The%20EU%20MDR%20is%20a,diagnostic%20medical%20devices%20in%20Europe.

2.   Nüssler, A. (2023). The new European Medical Device Regulation: Friend or foe for hospitals and patients? Injury, 54, 110907. https://doi.org/10.1016/j.injury.2023.110907

3.   Medical device regulation: landscape and trends. (n.d.). Retrieved from https://www.elsevier.com/industry/medical-device-regulation

4.   Dagher, G., Becker, K., Bonin, S., Foy, C., Gelmini, S., Kubista, M., Kungl, P., Oelmueller, U., Parkes, H., Pinzani, P., Riegman, P., Schröder, U., Stumptner, C., Turano, P., Sjöback, R., Wutte, A., & Zatloukal, K. (2019). Pre-analytical processes in medical diagnostics: New regulatory requirements and standards. New Biotechnology, 52, 121-125. https://doi.org/10.1016/j.nbt.2019.05.002

5.   Two Most Common IVDR Challenges with Solutions. (n.d.). Retrieved from https://www.nsf.org/knowledge-library/most-common-ivdr-challenges