Existing proposals for integration of a variety of regulations into standardized Medical Devices Regulations (MDR) and In Vitro Diagnostic Devices Regulations (IVDR) will provide a stable regulatory framework for the coming decades!
Our Whitepaper concerning 'Revision of the EU Medical Devices Regulations' discusses the most important and relevant items within the MDR/IVDR legislative proposals. Although crucial elements of the regulations are under review and subject to change, one thing is clear: The MDR and IVDR regulations will cause important changes in the operational and strategic processes of involved organizations.The MDR / IVDR will bring significant changes in EU directives covering medical devices, in vitro diagnostics, Active Pharmaceutical Ingredients (API's) and cosmetics, which will require significantly higher investments from manufacturers and other companies to be in compliance with the new EU regulations & requirements. Companies, in particularly manufacturers, need to anticipate and prepare to deal with proposed changes in a pro-active and timely manner to avoid having CE certificates suspended or revoked.
Seen below, and as mentioned within the Whitepaper, is an indication of the timing for regulatory changes, as well as a defined transition period.
Whether regulatory strategy, regulatory science, quality assurance, risk management, technical product documentation, clinical evaluation and assessments, validation, auditing, or testing, we will help you by providing the following services:
- Gap analyses of your risk management assessments, biological evaluation report, product testing report and strategy, clinical evaluation plan or other support to demonstrate that your product technical documentation is in compliance with the requirements of the new MDR/IVDR.
- Qualified Person (QP) activities, such as post marketing vigilance and involvement in clinical evaluations.
- Auditing your supply chain and/or performing unannounced inspections to accurately test your management system. We, then, provide you with an accurate assessment of your organization and your supply chain management's ability to absorb any unannounced inspections by notified bodies.
- Train and support your efforts to be in compliance with the new medical device regulatory requirements.
