MDR/IVDR Update

REVISION! European regulations for medical devices and in vitro diagnostic medical devices

Both the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) came into force on 26 May 2017 and became directly applicable 26 May 2021 and 26 May 2022, respectively. These new Regulations replace the Active Implantable Medical Devices Directive (AIMDD), Medical Devices Directive (MDD) and In Vitro Diagnostic Medical Devices Directive (IVDD) and set new rules for applying a CE mark to devices qualified as medical devices and in vitro diagnostic medical devices.

As of 26 May 2021, both the AIMDD and the MDD have been rescinded, and new devices can no longer be CE marked under these Directives. Similar, the IVDD have been rescinded on 26 May 2022. Both the new Regulations have the goal to ostensibly enhance safety of medical devices made available on the EU market, create transparency and predictability.

Acknowledging a lack of capacity for CE certification by EU Notified Bodies which would have led to medical devices shortage on the EU market and others, the EC published an amendment of the EU MDR and IVDR on March 20, 2023 which extends its transition deadlines and removes the “sell off” date of May 2025 under both MDR and the In Vitro Diagnostic Devices Regulation (IVDR) to prevent safe devices which are already on the market from being discarded.

The new Regulations represent a significant update of the Directives and underlying requirements. Companies who wish to continue placing their devices on the market have to meet enhanced requirements to support the safety and performance of devices and be transparent about the respective data. All devices irrespectively of the risk class need to comply with enhanced requirements, yet the highest risk devices are subjected to more stringent oversight by the national competent authorities and Notified Bodies. The changes imposed by the EU Regulations also affect territories outside the EU where CE marking is recognized as a basis for product registration (e.g., Turkey, Australia).

As a leader in healthcare and patient safety, we are driving the implementation of policies and procedures to ensure compliance with the new requirements by the dates required by the Regulations. BD (Becton, Dickinson and Company) is proud to have been supporting our customers and healthcare professionals for more than 125 years, and we are committed to continue doing so by delivering safe and effective medical devices that are advancing the world of health™.

And as such, a global cross-functional team at BD is working on the seamless implementation of the MDR and IVDR requirements across our entire company. This includes a close review of our product portfolio and processes to drive efficiencies where possible while ensuring that the devices bearing a CE mark under the Directives can continue to be placed on the market and made available to the healthcare communities.

Transitional provision for MDs as per MDR and the amendment Regulation (EU) 2023/607. The deadlines are as follows for products that transition under the scope of the MDR:

• Deadline for legacy class III/class IIb implantable devices: 31 December 2027. However, there is exception for class IIb implantable devices, except sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors for which the deadline is 31 December2028.
• Deadline for legacy class IIa, and class I products needing the involvement of a notified body, (i.e., those placed on the market in a sterile condition or having a measuring function): 31 December 2028

To benefit of extended transition, products have to meet a certain number of cumulative conditions.

For products not transitioning to MDR, the deadline remains May 2024 or the expiry date of the corresponding CE certificate, whichever comes first.

Transitional provisions for IVDs as per IVDR and the amendment Regulation EU 2022/112

1. IVDD Annex II devices and self-tests may be placed on the market until either their existing CE certificate expires or until 26 May 2025, whichever comes first and put into service and/or made available until 26 May 2026
2. IVDs that move to Class D under IVDR, may be placed on the market until 26 May 2025 and put into service and/or made available until 26 May 2026
3. IVDs that move to Class C under IVDR may be placed on the market until 26 May 2026 and put into service and/or made available until 26 May 2027
4. IVDs that move to Class B and Class A sterile under IVDR may be placed on the market until 26 May 2027 and put into service and/or made available until 26 May 2028
5. Class A non-sterile IVDs, such as instruments that remain to be self-declared under the IVDR and all devices requiring the NB intervention under the IVDR, but that do not have a declaration of conformity issued prior to 26 May 2022 (new devices) must be compliant with the IVDR as for 26 May 2022 (DoA)

Laboratory Developed Tests/ In house assays as per the amendment Regulation EU 2022/112

The IVDR does not only impact manufacturers of IVDs, but also their customers, health institutions, such as laboratories. The new amendment of the IVDR grants the health institutions and laboratories up to 6 more years to fully comply with the relevant conditions and/or requirements if they see the clinical need to manufacture their own devices. The justification for the need of in-house assay will be required from 26 May 2028.

The MDR and IVDR is a paradigm shift in how medical devices and IVDs are regulated in the EU and affects the entire medical technology industry. As such, we are aware that these changes will generate enquiries from our customers. BD is making the commitment to keep our customers informed on relevant updates to our products as our journey towards compliance progresses.

With the positive changes that the MDR and IVDR bring to the European regulatory framework, we look forward to having our products and unique technologies continue to serve you and your patients.

For more information on the impact of the regulations on healthcare professionals and health institutions, please refer to the European Commission’s Factsheet for healthcare professionals and health institutions. https://health.ec.europa.eu/publications/factsheet-healthcare-professionals-and-healthcare-institutions_en