MedTech Europe has welcomed European Commission plans to form a European Health Union, whilst also flagging potential issues with such an organisation.

The European Commission proposal argued that a union would enable the EU to learn from the COVID-19 pandemic and, moving forward, improve its ability to respond to similar international health crises.

According to the European Commission, the union could help to tackle similar future scenarios by acting to prevent shortages of medical equipment and devices and by enabling the assessment of high-risk products.

The Commission said that it would empower the EMA to stop device shortages, support the development of new products and "ensure smooth functioning of expert panels for the assessment of some high-risk medical devices."

It added: "By providing a permanent structure within the Agency for the functioning of expert panels, the proposal will create the ability to quickly provide scientific advice and technical support on demand in case of crisis and to support the assessment of certain high-risk medical devices."

MedTech Europe welcomed the proposal, saying it could both improve early threat alertness and harmonise responses. However, it also raised concerns over moving responsibility for administering IVDR and MDR expert panels to the EMA, saying it could slow deployment.

The trade group also emphasised the importance of ensuring that the proposed EMA Executive Steering Group for Medical Devices would work in harmony with the Medical Devices Coordination Group.

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