A key factor for success in developing a new medical device technology, is identifying the optimum route to EU market approval and reimbursement.
With the implementation of the new Medical Devices Regulation (MDR) and other changes rapidly occurring in the market, entering the EU market can be a real challenge. MedPass has the up-to-date knowledge and experience to help Medical device manufacturers determine the most efficient and cost-effective pathways to medical device regulatory approval and reimbursement in Europe.
Our senior consultants, many of whom have Notified Body and Competent Authority experience, have advance knowledge of regulatory developments from key standards committees such as BSI CH/210/4 on Risk management, ISO/TC 194 on Clinical and biological evaluation, the ISO 5840 series covering transcatheter heart valve technologies and EU Commission working groups related to implementation of the MDR such as clinical investigations and evaluations, vigilance and EUDAMED. Our reimbursement team has Ministry of Health experience and contacts with some of the leading EU health economists specialized in medical device reimbursement.
Whether the goal is to conduct a clinical trial for CE marking or FDA approval, obtain market approval, funding or reimbursement, MedPass can help develop strategies to reduce timelines and increase cost efficiencies.
Some of the key services we offer include:
- Liaison with EU Notified Bodies e.g. BSI, DEKRA, TÜV SÜD, LNE G-Med, SGS, PCBC, etc) for all certification issues.
- Device Classification.
- Advice on V&V testing including biocompatibility.
- Risk Management Plans and Reports.
- Clinical Evaluations Report (CER) and Literature Review (LR) compliant with MEDDEV 2.7/1 rev.4 and MDR.
- Post Market Surveillance Plans and Reports.
- Post Market Clinical Follow-up Plans and Reports.
- Technical files and Design Dossiers.
- MDR mock technical file reviews and QMS audits
- Advice on Quality Management Systems.
- Literature reviews.
- Periodic Safety Update Report (PSUR), Summary of Safety and Clinical Performance (SSCP) and other Regulatory Reports.
- Clinical Evaluation Plan (CEP)
- MDR Gap Analyses
- Remediation Strategy & Support (liaison with Notified Bodies, Competent Authorities, etc).
- Due Diligence Reports (device / technology).