EU Medical Device Regulation (MDR) 2017/745
Course Description
This two-day training on the Medical Device Regulation (MDR) 2017/745 is to provide Medical Device Manufacturers an overview of the MDR.
Who Should Attend
Quality and Regulatory professionals including individuals in the Medical Device Industry who need to understand the MDR and know what to do to comply with it today and tomorrow. A good understanding of the MDD would be beneficial.
Topics Include
Background on CE-Marking
Intent of the change from MDD to MDR
Similarities between the MDD and MDR “process”
Format of the MDR to understand the Chapter, Article and Annexes
New Responsibilities and authorities of all parties involved, including: Notified Bodies, Competent Authorities, Authorized Representatives, Expert Panels, Economic Operators, Importers, Distributors, Manufacturers and the Person Responsible for Regulatory Compliance
Device Classifications including:
Single Use Device & Reprocessing
System & Procedure Pack
Technical Documentation (replacing Technical File/Design Dossier)
General Safety and Performance Requirements (GSPR) (replacing Essential Requirements)
Harmonized Standards, Common Specifications and Guidance documents
Initial Assessments, Technical Documentation review, Continuous Assessments
Routine Product Testing at the Manufacturer, Supplier and on the Market
Clinical Evaluation
Clinical Evaluation Plan (CEP)
Clinical Development Plan
Clinical Investigation Plan/Report
Summary of Safety and Clinical Performance (SSCP)
Clinical Evaluation Report (CER)
Post Market Surveillance (PMS)
Post Market Surveillance (PMS) Plan
Post Market Clinical Follow-Up (PMCF) Plan/Report
Periodic Safety Update Report (PSUR)
Post Market Surveillance (PMS) Report
Vigilance including Trend Reporting
European Database on Medical Devices (Eudamed)
Unique Device Identification (UDI)
MDD to MDR Transition timing and requirements
Official changes to the MDR (corrigendum)
What to do today and what to expect tomorrow
Where to go for guidance
16 Hours
Contact Information
Email
paulette@pyyoungassociates.com
Phone
1 (650) 967-2700
Address
P.O. Box 2103
Sunnyvale, CA 94087-0103