Comparison Between the EU and FDA Regulatory Protocols

Why Should You Attend:

There have been several ongoing changes adopted by the FDA, EU, ISO 13485, Medical Device Audits, and related to medical devices in just the last few years. And in order to understand these changes and adhere to all these regulatory changes is advantageous to all medical device manufacturers involved in the manufacture of class II and class III devices.

The European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) came into effect as of May 26th, 2017. The clock is ticking for current Medical Device manufacturers in the European marketplace to develop and implement strategies to be fully compliant.

Manufacturers of currently approved in vitro diagnostic medical devices will have a transition time of five years, up to 26 May 2022 to meet the requirements of the IVDR. Products already certified by a Notified Body may be placed on the market for further 2 years under some conditions, e.g. the certificate issued under the IVDD is still valid and subject to surveillance by the Notified Body who had issued it and no significant changes to the product are made.

What are the key changes expected in the new IVDR? The actual terms of the proposed regulation are subject to change until final publication of the IVDR in the Official Journal of the European Union. Some of the key changes expected include:

• Product scope expansion. Expanded scope will cover diagnostic (including Internet-based) services, genetic testing and other tests that provide information about a patient’s predisposition to a specific disease or susceptibility for a medical treatment.
• Reclassification of devices according to risk. Risk classes will range from Class A for low risk devices to Class D for high risk devices.
• More rigorous clinical evidence. Manufacturers will need to conduct clinical performance studies and provide evidence of safety and performance according to a device’s assigned risk class.

The new In Vitro Diagnostic Regulation (IVDR) is complex and the changes it embodies are significant. Our white paper serves as a first step for medical device manufacturers in the EU Market to better understand the immediate IVDR implications by:

• Analyzing the most influential changes and highlighting their implications for regulated medical device companies.
• Providing practical steps that medical device manufacturers should take as soon as possible to prepare for this substantial change in the European regulatory environment.

Areas Covered in the Webinar:

• 21 CFR 820
• 90/385/EEC regarding active implantable medical devices
• A Guide to the EU Directive Concerning Liability for Defective Products (Product Liability Directive)
• Applying Human Factors and Usability Engineering to Medical Devices
• Design verification/validation and process validation
• Directive 93/42/EEC covering medical devices modified by the directive 2007/47/CE
• EU-Medical Device Regulations MDR/2017
• FDA Design Considerations
• FDA verification and validation procedures
• ISO 10993-1 - Biological evaluation of medical devices - Part 1
• ISO 13485 Medical devices -- Quality management systems
• ISO 14937:2009 - Sterilization of health care products
• ISO 14971 - Medical Device Risk Management
• ISO 9001:2015 Quality management systems — Requirements
• ISO/TR 80002-2:2017 - Medical device software -- Part 2: Validation of software for medical device quality systems
• MAUDE - Manufacturer and User Facility Device Experience
• MEDDEV 2.7.1 rev 4 and Clinical Evaluation Reports (CER) for Medical Devices
• Medical Device Directive 93/42/EEC regarding medical devices
• Medical Device Reporting - 21 CFR Part 803

Who Will Benefit:

• Professionals with roles in Medical Device Manufacturing, Customer service, and Quality assurance

Free Materials:

• Reference documents
• Rule documents or guidance
• Checklist
• SOP template
• Easy fill in forms
• Articles

George Yanulis
President, Medical Device Consulting LLC

Dr. George Yanulis has consulted in Medical Device Product Development and Research for 20 years and has a Doctorate and Master’s Degree in Biomedical Engineering. He has conducted cardiovascular device research at the Cleveland Clinic Foundation on cardiac pacing paradigms used in heart failure patients. In addition, Dr. Yanulis has been involved in the R&D Medical Device Consulting & Litigation Support as an Expert Witness for over 10 years and has been involved in numerous medical device liability and patent infringement cases. He provides expertise to attorneys, medical device companies, health care systems and insurance carriers related to FDA medical device controls, PMAs, post-market surveillance issues, medical device/product failures and IP medical device issues. In addition, he has reviewed MDR(s) and other adverse events related to implant device failure. Dr. Yanulis is highly motivated in maintaining and providing the highest level of quality in the design, development and safe and effective use of all types of cardiac device implants.

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