We provide full-scope legal and regulatory advisory services for all stages of the lifecycle of medical devices and in-vitro diagnostic medical devices – from qualification and clinical evaluation, through manufacturing, technical documentation and the reimbursement strategy, to advertising, distribution and post-market surveillance. We advise manufacturers, importers and distributors, offering support with QMS, regulatory compliance, stakeholder engagement and alignment with EU law. Our expertise also covers software as a medical device, AI technologies, compliance systems and representation in disputes with supervisory authorities. We combine legal precision with an in-depth understanding of the medtech industry’s operational and regulatory environment.
Qualification and classification of medical devices / in-vitro diagnostic medical devices
Manufacturing, design & development of medical devices / in-vitro diagnostic medical devices
Development, implementation, and audits of QMS
Preparation of a regulatory strategy
Support in the preparation of technical documentation
Acting as the Person Responsible for Regulatory Compliance (PRRC)
Clinical evaluations / Performance evaluations
- legal and regulatory support in determining the approach to conducting clinical evaluations / performance evaluations
- CTAs – preparation and negotiation of clinical trial / performance study contracts
- review of Informed Consent Forms (ICF)
- data protection and personal data processing in clinical trials / performance studies
- secondary use of medical data
- assistance in contacts with regulatory authorities and the ethics committee
AI / machine learning & Software as a Medical Device (SaMD)
Distribution of devices
Reimbursement and market access
- strategic advice and preparation of market access strategies
- review of reimbursement applications including RSS
- support in correspondence with the Ministry of Health, the HTA Agency (AOTMiT) and the Economic Commission
- participation in pricing negotiations
- participation in meetings with the Ministry of Health and other stakeholders
- preparation of position papers and analyses re. various aspects of reimbursement proceedings
- advisory on the reimbursement of medical devices on prescription and other financing models for medical devices
- disputes with the National Health Fund (NHF ) and the Ministry of Health (MoH)
Advertising of medical devices
- review of advertising and promotional materials
- relations with Healthcare Organisations (HCOs), Healthcare Professionals (HCPs) and Patient Organisations (POs)
- development / update of marketing procedures
- relations with wholesalers, pharmacies and medical supply stores
- advisory on Codes of Good Practice
- umbrella branding
- drafting of agreements with service providers (e.g., marketing agencies)
Post-market surveillance system
- PSUR – periodic safety update reports
- PMCF – post-market clinical follow-up
- PMPF – post market performance follow up
- FSCA – field safety corrective actions
- FSN – Field Safety Note
- SSCP – Summary of Safety and Clinical Performance
- SSP – Summary of Safety and Performance (for IVDs)
- RMR – Risk Management Report