CE Marking: Medical Devices & IVDs

(On-site or Virtual Private Group/Company Training)

Date: Your Choice

Location: On-site or Virtual

Who: Your entire company, department, project team, you select

Overview:
 
All medical devices, including IVDs, must have a CE Mark in order to be sold in the European Union.  And, the rules for CE marking these devices are changing. This course will delve into the details of CE Marking medical devices, active implantables, and IVDs. Topics such as product classification (IVD classification changes significantly in the new regulation), Technical File construction, authorized representatives, Notified Body selection/audits, directives & the new regulations (MDR & IVDR), as well as timing of regulation impacts will be reviewed. Special focus will be given to planning for moving from the directives to the regulations, technical file / design dossier construction including selection of standards and how to ensure that the file continues to reflect the current state of the product while providing insight into how to remain current with the ever-changing landscape of standards, guidance documents and emerging rules that may impact your product. This course will help you develop documentation that clearly shows a product complies with the directive/regulation and supports the CE mark. It will be of interest to companies that are looking to CE Mark new products and those wishing to maintain their CE Mark. The course will be of interest to staff involved in CE Mark approvals, related documentation processes and ISO 13485 compliance programs (also see our course on ISO 13485).

Special note for IVD manufacturers: The new IVD Regulation (IVDR) creates a significant change in the classification scheme for IVD products; under the IVDR many more IVD’s will require a Notified Body (NB) review of their technical files, and therefore, they should get started very soon to prepare. Only 20% of IVD’s now require a NB, but under the IVDR, 80% of IVD’s will require a NB.

What you will learn:

• The CE Mark approval process for medical devices, active implantables & IVDs.
• The roles of all parties involved: Competent Authority, the new MDCG, Notified Body, authorized representative, manufacturer, importer, and distributor.
• Directives and new Regulations, how to achieve compliance (CE Mark) for both.
• How to classify your Medical Device or IVD and what are “routes to conformity”.
• How to create technical files & dossiers that Notified Bodies will accept.
• How to document and show compliance to General Safety and Performance (formerly Essential) Requirements.
• Standards & guidance to use in demonstrating compliance.
• Use of Common Technical Specifications (CTS).
• Electronic IFU Rules – can you avoid printing? What Languages are required?
• Latest information on the new Medical Device & IVD Regulations.
• Timing and planning for compliance to Regulations.

Benefits of Attending:

• Learn the requirements for CE Marking devices & IVDs.
• Access the European Community.
• Hear up to date information on directives/new regulations and the CE Mark processes.
• See how standards fit into the technical documentation.
• Determine the best route to conformity for your situation.
• Prevent delays during the approval process.
• Stay ahead of or keep up with your competitors.
• Understand the relationship between CE Marking and ISO 13485.

Abbreviated Outline:

• A. CE Mark Overview
• B. Classification & Conformity Assessment Routes
• C. Creating a Technical File / Design Dossier under Directives and new Regulations
• D. Understanding and Meeting the General Safety & Performance (formerly Essential) Requirements
• E. The Notified Body Audit (beware of the unannounced audit program)
• F. Guidance Documents (including vigilance)
• G. Maintaining Technical Files / Design Dossiers
• H. Overview of Other Directives to Consider
• I. Update on the proposed amendments to the regulations/directives.
• J. Review and Summary

Instructor(s): To be determined based on schedule and your specific needs. All instructors are very experienced and experts in the field being taught. Biographies will be provided and a discussion with the instructor(s) will be arranged so that a proposal can be provided for training that meets your needs.

Duration: Standard course is approximately 8 hours. Customized courses can vary. On-site courses are typically taught in 1 day. Virtual courses can be taught over multiple days, e.g. 2 days for 4 hours/day, etc.

Request a training proposal for your company.