The new EU Medical Devices Regulation (EU MDR) will profoundly affect the medical device market in Europe.  Implementation deadlines are rapidly approaching.  Companies that have not already made significant progress in planning and preparation may be at risk of losing EU product registrations.  With notified bodies and consultants understaffed and overcommitted, help will be hard to find.

Anyone can read the regulation, but interpretation remains vague in some areas, and even the best prepared companies have large teams struggling with impact analysis, strategy, budgeting, and implementation.

This two-day conference features presentations and panel discussions by speakers from notified bodies and top medical device companies.  Pooling knowledge and strategies will help the industry as a whole better plan for the massive and costly upcoming changes.

EU MDR Implementation Workshop

Agenda Outline

 Strategy, Planning, and Budgeting

• Performing a gap analysis
• Portfolio review and global markets impact analysis
• Budgeting – translating disparate RA/QA, clinical, and other requirements into short- and long-term business costs
• Structuring the project – at senior management level coordinating an enterprise-wide cross-functional approach
• Planning for lingering uncertainties

Notified Bodies

• Notified body preparation steps and readiness
• Expanding notified body responsibilities and oversight
• Consequences of BREXIT on UK notified bodies and economic operators

Quality Processes, Documentation, and Information Technology

• Quality system upgrade, modification, and integration
• Increased management responsibility
• Process redesign – consistent processes, IT systems, and technical files across the organization
• IT systems and procedures to handle new data requirements

Clinical 

•  Additional clinical evidence requirements for new and legacy products 
• Defining “sufficient clinical evidence” especially for low-risk legacy products
• Summary of Safety and Clinical Performance (SSCP)
• Creating and updating Clinical Evaluation Reports (CER)
• Closer alignment between risk management and clinical evaluations
• Performing clinical evidence gap analysis

Postmarket Requirements

• Postmarket Clinical Follow-Up Studies (PMCF)
• Justifications if long-term data is unavailable
• Periodic Safety Update Reports (PSUR), analysis of postmarket information, and update of benefit-risk profiles
• Eudamed database reporting – IT considerations, timeline
• Linkage of postmarket data with other functions such as risk management, clinical, and promotional materials

Remediation of Legacy Devices

• Review and gap analysis of legacy devices
• Practical, clinical, and financial triage of legacy devices
• Remediation of legacy devices, including those grandfathered under MDD
• Resource requirements 

UDI, Labeling, and Public Information

• Eudamed issues and concerns
• Concerns regarding public information (e.g. SS&CP, new IFU requirements)
• Gap analysis of clinical investigation databases to interface with Eudamed
• Interaction of the General Data Protection Regulation (GDPR) and MDR public information requirements?
• New IFU/labeling requirements
• UDI implementation – Comparison and overlap with US requirements.What is Basic UDI-DI? What is Unit of Use DI?

Economic Operators 

• Supply chain, supplier management and economic operators - practical challenges
• Re-evaluation of current suppliers
• Assessment of systems for evaluating, monitoring and documenting suppler performance and providing greater traceability and transparency

Coordination with other Issues

• Redundancy and procedural economies in coordinated planning for new regulations and standards, e.g.13485:2016, MDSAP
• Greater emphasis on risk management throughout the product life cycle; closer alignment of 13485:2016 with 14971
• Strategic corporate decision on whether the goal is to comply or to use this opportunity to improve quality beyond compliance
• Planning for the unknown impact of BREXIT
• Hazardous materials and sterilization

Software

• Software – classification under rule 11.
• What about apps?
• Performing CER for software