Medical Devices – EU MDR & FDA Regulatory Affairs
Supporting Successful Medical Device Development, Compliance, and International Market Authorization
Medical device regulatory compliance requires the effective integration of product classification, risk management, technical documentation, clinical evidence, and quality management.
Avary Consulting supports medical device manufacturers in implementing the requirements of Regulation (EU) 2017/745 (Medical Device Regulation – MDR).
Our consulting services particularly address the General Safety and Performance Requirements under Annex I, technical documentation requirements under Annexes II and III, clinical evaluation requirements under Article 61 and Annex XIV, and applicable conformity assessment and post-market surveillance obligations.
We also consider relevant MDCG guidance documents and applicable standards, including ISO 13485 for quality management systems and ISO 14971 for medical device risk management.
For the United States, we support the assessment of FDA device classification and potential regulatory pathways, including 510(k), De Novo, and Premarket Approval (PMA).
Our approach considers applicable U.S. medical device regulations, including 21 CFR Parts 807, 814, and 820, as relevant to the product.
Our services include:
EU MDR and FDA regulatory strategies
Product classification and regulatory assessment
Technical documentation and GSPR compliance assessment
Coordination of technical and clinical evidence
Regulatory gap assessments
Support for conformity assessment and regulatory submission processes
Change management and regulatory remediation
Our Recommendation: Manufacturers should align regulatory classification, intended purpose, clinical evidence strategy, and technical testing plans as early as possible to minimize documentation gaps, reduce rework, and improve development efficiency.