Clinical Evaluation & Clinical Investigations
Clinical Evaluation & Clinical Investigations
Clinical Evidence as the Foundation for Regulatory Decisions
Clinical evidence is a critical component in evaluating the safety, performance, and clinical benefits of medical devices.
Avary Consulting supports manufacturers in the regulatory planning and coordination of clinical evaluations and clinical investigations.
For medical devices, we consider Article 61 and Annex XIV of the MDR regarding clinical evaluation, as well as Article 62 et seq. and Annex XV regarding clinical investigations, where applicable.
We also incorporate relevant MDCG guidance and applicable requirements of ISO 14155.
Our services include:
- Development of regulatory strategies for clinical evidence
- Support for Clinical Evaluation Plans (CEP)
- Support for Clinical Evaluation Reports (CER)
- Identification of clinical evidence gaps
- Regulatory preparation and coordination of clinical investigations
- Coordination with clinical service providers and study partners
- Support for Post-Market Clinical Follow-up (PMCF) planning
Our Recommendation for Manufacturers: Assess clinical evidence requirements when defining the product strategy. An early gap assessment can help establish realistic timelines and resource requirements for necessary clinical activities.