EU: What Will Happen To The IVD And Medical Device Sectors In The EU in 2023?

European Commission (EC) has foreseen the possibility of disruption occurring for medical device supplies as there are many issues regarding the implementation of medical device regulation (MDR). During the meeting of the Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) on June 2022, ministers expressed concern about the implementation challenges that might trigger the discontinuity of medical device products in the medical market as well as delays in medical treatment.

Ministers had agreed to put top urgency priority and Medical Device Coordination Group (MDCG) was responsible to seek for the solutions. Later on December 2022, European Commission presented Proposal No.15520/22 and factsheet sharing the overview and actions to be taken to combat the concern.

The transition for the implementation of the new rules is getting held up by the limited number of notified bodies and insufficient preparation of the company. Currently, companies are not well prepared to obey the regulation requirements before the transition period ends. Products are not allowed to be placed on the EU market once the MDR certification expires. Besides, there are only 36 notified bodies to process thousands of manufacturers’ certification applications.

Therefore, EC proposed an amendment to delay the implementation of Medical Device Regulation (MDR) (EU) 2017/745 and In Vitro Diagnostic Medical Devices Regulation (IVDR) (EU) 2017/746 by introducing gradual extension and proposes to eradicate “sell off” deadline. Below are the details of the actions proposed in the amendment.

1. Gradual extension for the transition period is extended for the high-risk device from 26 May 2024 until 31 December 2027 and for the lower-risk devices is from 26 May 2024 until 31 December 2028. On an important note, the transmission extension to MDR is only applicable for the devices that already take steps on MDR implementation.

2. Extension of certificates validity issued under Council Directive as from 25 May 2017 and remains valid until 26 May 2021 should remain valid until the end of the transition period subject to conditions. The extension time should be enough for the notified bodies to do the assessment.

3. Vanish the “sell off” deadline for products to be available on the market without an expiry period to prevent discarding the safe medical devices on market and causing shortages on market and patients having fewer treatment choices.

Medical Device Coordination Group (MDCG) also come out proposing to add more numbers of Notified Bodies (NB) and increase the action momentum while assessing medical devices. Hence, the market would not involve in medical device shortages.

As more than 95% of medical device manufacturers in Europe’s market consist of small and medium enterprises, European Commission suggesting to establish EU4Health as a financial support aid. EU4Health is expected to assist orphan devices in supporting programs, supporting the coordination of Notified Bodies and investing in innovation and governance.

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