Regulatory and Clinical Strategy under EU MDR or EU IVDR
Selecting an appropriate regulatory and/or clinical strategy for your medical device is a critical aspect of both the pre- and post-market device lifecycle. Whether the device is new to the market, planning significant changes or is undergoing initial conformity assessment under EU 2017/745 (EU MDR) or under EU 2017/746 (EU IVDR), an effective regulatory/clinical strategy can reduce both time and cost to market. Many manufactures may over or under design their strategy which can increase cost or submission risk.
To develop a regulatory strategy under the EU MDR or EU IVDR, a manufacturer should follow these general steps:
AKRA TEAM will help you to develop a comprehensive regulatory strategy based on your device lifecycle. Regulatory strategy can involve the following aspects:
- Documentation and testing strategy
- Market authorization sequence and timing
- Submission pathway, strategy and schedule.
The regulatory strategy should be incorporated as soon as possible and will be most effective when developed at the earliest stage of the project.
Support & Training
Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.
- Strategy for regulatory compliance, MDR Art 10(9(a))/ /IVDR Art 10(8(a))
- Clinical evaluation plan/Clinical development plan
- Performance evaluation plan
- Device specific regulatory plan