CE Marking Medical Devices: The Process, Part 2 - New EU Medical Device Regulations

CE Marking Medical Devices: The Process, Part 2 - New EU Medical Device Regulations

Date: December 6, 2018, 3:00 p.m. EST

By Lisa C. Graney, RAC & Sam Mostafavi, MS, MBA

Overview

Interested in gaining access to the European market with your medical device or combination product? This multi-part webinar series details the requirements for obtaining approval to market medical devices in the European Economic Area (EEA). Topics will include comparison of CE Marking requirements vs. US FDA requirements, the new medical device regulations, classification of devices, clinical evaluation, use of standards and the new General Data Protection Regulation (GDPR).

The second webinar in the series, “The New EU Medical Device Regulation: Regulation (EU) 2017/745,” will introduce the audience to the new EU Medical Device Regulations that replace Council Directive 93/42/EEC (MDD) for CE marking medical devices. We will discuss the important changes and include the following areas:

  • Comparison to MDD
  • Important Timelines
  • Oversight of Notified Bodies
  • General Safety and Performance Requirements (GSPR)
  • Device Classification changes
  • Traceability and UDI
  • MDCG and Common Specifications
  • Clinical Evaluation, PMCF and PSUR
  • Additional Documents
  • Recommended Preparation for Transition

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About the Hosts

 

Lisa C. Graney, RAC joined Biologics Consulting in July 2017 and has 25 years’ experience in regulatory affairs and quality management systems for medical device companies, including orthopedics, ophthalmics, IVD’s, imaging anesthesiology and regenerative medicine (tissues and cells). Lisa and her teams have achieved numerous product approvals in both U.S. and international markets.

Prior to joining Biologics Consulting, Lisa was Vice President Global Regulatory & Clinical Affairs at LifeNet Health, where she became an SME in US and cell/ tissue international regulation and prepared regulatory strategies and analyses for products requiring BLA’s, 510(k)s, and RFDs as well as 361 HCT/Ps. Prior to LifeNet Health, Lisa was Worldwide Vice President Regulatory Affairs, at DePuy Synthes Inc., companies of Johnson & Johnson where she led an international team that achieved sixty+ 510(k) clearances, overhauling the EU Technical File program and files, and supported product submissions in 100+ countries. Read More >

 

Sam Mostafavi, MS, MBA joined Biologics Consulting in August 2018 and has over twenty years of drug/medical device industry expertise, including twelve years of management experience at various organizations. He has direct experience in product and software development lifecycle from concept to commercialization, including design development, regulatory strategy, authoring of regulatory submissions, study planning, quality system, manufacturing, and post market surveillance. Mr. Mostafavi also has experience in international regulatory approval and production setup and qualification.

Mr. Mostafavi previously worked for Conavi Medical as Head of Quality and Regulatory implementing a quality management system compliant with ISO 13485, as well as obtaining CE Mark, Health Canada MDEL, and FDA clearances. Read More >


About The Biologics Consulting Expert Edge Webinar Series

The Expert Edge Webinar Series was created by Biologics Consulting in an effort to share the latest Agency guidance and best practices with leaders throughout the biopharmaceutical and medical device industries. Each interactive, web-based workshop in the series is hosted by an accomplished subject-matter expert and designed to provide participants with a pathway to success through some of the most complex regulatory and product development challenges in the Industry today.