Regulatory and Clinical Strategy under EU MDR or EU IVDR
General Background
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:
- Understand the regulatory requirements. Familiarize yourself with EU MDR and EU IVDR requirements, including the conformity assessment routes, classification rules, clinical evaluation, and post-market surveillance.
- Identify the relevant regulatory pathway. Determine the regulatory pathway for your device based on its classification and intended purpose.
- Conduct a gap analysis. Compare the current technical documentation of your device to the EU MDR/ EU IVDR requirements and associated state of the art guidance and standards to identify any gaps that need to be addressed.
- Develop a clinical evaluation plan and clinical development plan. Develop or update your clinical evaluation/clinical development plan to ensure sufficient data is collected to support the safety and performance of your device.
- Work with a Notified Body. When relevant, communicate with your Notified Body who will conduct the conformity assessment and issue the CE mark, which is mandatory for the devices to be placed on the EU market.
- Develop a post-market surveillance and post-market clinical follow-up plan. Develop or update your plan for monitoring the safety and performance of your device in post-market. This will ensure relevant safety and performance data is continuously collected for the subject device.
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.
Under EU MDR and EU IVDR manufactures must demonstrate sufficient evidence supporting conformity with relevant general safety and performance requirements. As manufacturers often need to gather additional evidence to support a significant change or initial conformity assessment, is important to ensure relevant and sufficient data is collected to address any gaps in evidence. Manufactures may collect this data through various modalities from high-quality surveys to randomized clinical investigations.
Akra Team will help you to develop an effective clinical strategy for pre- or post-market lifecycles. An effective strategy will also ensure there are no undue delays in market access and reduce risk during assessment.
Support & Training
Contact AKRA TEAM for support, hands on implementation services and personalized training by experts with key competencies in the areas listed below.
Key points
Our Services
Training
AKRA TEAM provides training regarding both clinical and regulatory strategy. Our team of senior and clinical consultants have previous experience working in notified bodies and understand the expectations and requirements under EU MDR and EU IVDR. We can provide training suited to the relevant risk class and device characteristics.
Process and Templates Development
AKRA TEAM has proven procedure and document templates are available for all aspects of regulatory and clinical strategy including:
- 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
Gap Assessment
AKRA TEAM offers comprehensive gap assessments of regulatory/clinical strategies to highlight areas of risk or improvement prior to submission. AKRA TEAM will rank risks from high to low while offering mitigations to close any identified gaps.
Implementation
AKRA TEAM has an experienced team of clinicians and regulatory experts available to develop a regulatory/clinical strategy based on the device type and risk-class. We offer custom tailored solutions or comprehensive solutions to addresses the needs of any manufacturer.