Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table

Evolve the Medical Device Regulation system to facilitate priority access for innovative devices for unmet needs and orphan cardiovascular (CV) devices in European Union (EU) countries

Mid-term: consider a single EU regulatory agency for devices

Enhance predictability of approval through early scientific advice from regulators

Establish unique regulatory pathways for CV orphan, paediatric and innovative devices

Promote more efficient (re)certification of essential legacy CV devices

Improve transparency of sponsor interactions with Notified Bodies

Expand the roles of the Expert Panels to assist in approval of CV devices

Promote global regulatory harmonization, considering streamlined authorization of CV medical technologies across selected jurisdictions

Develop an efficient system to monitor device safety

Ensure funding for data collection platforms

Consider a pilot programme for joint approval of selected devices with other regions (i.e. US Food and Drug Administration)

Develop priority pathways for accelerated access to innovative or orphan devices

Increase recognition of the importance of early feasibility studies in the EU