MDR Readiness Superpack
EU MDR Becomes Effective in 612 days
The European Medical Device Regulation (MDR) is a new set of regulations that governs the production and distribution of medical devices in Europe, and compliance with the regulation is mandatory for medical device companies that want to sell their products in the European marketplace. If your company was already compliant with the Medical Devices Directive (MDD), don’t be fooled into complacency – the MDR represents brand new regulations with a lot of changes.
Key changes in MDR include:
- Reclassification of many medical devices to a higher risk class and a new classification for reusable surgical devices requiring notified body oversight.
- Companies undergoing transition will need to revisit core processes including the quality assurance, risk management, and post-market expectations.
- Manufacturers will need to generate and provide more in-depth clinical data to prove safety and performance claims including tighter equivalency standards.
- Annex I, General Safety and Performance Requirements, identifies new conditions that will need to be addressed for most legacy devices (CE marked under the MDD). Existing products must be re-certified in accordance with the new regulations.
The MDR Readiness Superpack includes two critical tools:
- A detailed and comprehensive checklist to help you identify gaps against the MDR, and
- A detailed checklist to help you assess any changes to your device classification per the MDR.
In addition, it includes four critical SOP’s to quickly close most common gaps:
- CE Marking SOP provides a method to assure that all CE Marked medical devices commercialized in the Union are in compliance with the European Medical Device Regulation MDR (EU) 2017/745.
- Clinical Evaluation and Post-Market Follow-Up SOP provides detailed instruction on: • Defining the scope of a clinical evaluation; • Identification of pertinent data and literature reviews; • Appraisal of pertinent data; analysis of clinical data; • Generating a Clinical Evaluation Report (CER). The procedure includes an instructive CER report template with guidance for each section. • Conducting Post Market Clinical Follow-Up (PMCF)
- Post Market Surveillance SOP helps govern all post market surveillance activities and provides instruction on: Post Market Surveillance Plan and Report (Includes Sample Plan); and Post Market Clinical Follow-Up (PMCF) requirements.
- Periodic Safety Update Report SOP provides detailed guidance on the required content of a Periodic Safety Update Report (PSUR) made part of the company’s post market surveillance and vigilance system.