IVDR Amendment
25/4/2024
On 25th April 2024, the European Parliament welcomed the adoption of “then” proposed and now-adopted amendments to REGULATION (EU) 2017/745 and REGULATION (EU) 2017/746 [MDR, IVDR].
The proposal document, published in January 2024, is now set to amend the regulations, giving more time for transition. The European Database on Medical Devices—EUDAMED—will also see a gradual and mandatory rollout. From the beginning of 2026, using several parts of Eudamed will become mandatory. This will increase transparency in the EU and provide an overview of medical devices available on the European market.
Key points to focus on Amendment of IVDR:
- New transitional Timeline: The availability of IVDs, such as HIV or hepatitis tests, is crucial for patients. A considerable number of IVDs currently on the market do not yet comply with the EU rules which have been applicable since May 2022. Subject to certain conditions, the new rules give more time for manufacturers to transition to the new requirements without compromising safety and mitigate the risk of shortages.
The additional time granted to companies depends on the type of device:
- high individual and public health risk devices such as HIV or hepatitis tests (class D) will have a transition period until December 2027;
- high individual and/or moderate public health risk devices such as cancer tests (class C) will have a transition period until December 2028;
- lower risk devices (class B) such as pregnancy tests and (class A) sterile devices such as blood collection tubes have a transition period until December 2029.
- Prior Notice in case of supply disruption: The amendment will add Article 10A to MDR and IVDR, which makes it mandatory for manufacturers to give a 6-month advance notice to competent authorities, distributors, and healthcare providers if they anticipate a disruption in the supply of their devices.
- Mandatory use of EUDAMED: From the beginning of 2026, several parts of EUDAMED will be mandatory and utilised in full capacity. This will first see a gradual rollout of ready-to-use modules followed by mandatory use of the features.
- Quality Management System: When you read between the lines, the accepted proposal document also highlighted the need for mandatory adherence and compliance to ISO 13485 as part of quality management system requirements.
What does this mean for Manufacturers?
- Manufacturers shouldn’t take their foot off the gas, considering this proposed extension means more time. Instead, they should use this time to act fast and comply with EU IVDR and EU MDR. Many giant manufacturers will knock on the doors of different notified bodies with their applications. This will affect the notified body’s capacity and cause a temporary disruption to the supply chain, as notified bodies will have a limited capacity. Engage early!
- In the case where Manufacturers intend to stop the supply of certain devices, article 10A makes it mandatory to submit a prior Notice to the European Commission.
- Manufacturers must get active and have all hands on deck to implement a QMS for the devices.
- Manufacturers and all related suppliers should be ready for phased adaptation of EUDAMED. This includes timely registrations, appropriate labelling and supply chain management.
The regulatory experts at Med-Di-Dia are here to assist our clients in developing proactive strategies that view mandatory compliance as an opportunity, not a barrier. We offer personalised services to all companies and guide them in meeting local and global regulatory requirements.
Contact us today to receive a tailored strategy for your products and company!
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