Objectives of the Presentation
Why Should you Attend
- Learn what goes into Technical File and the necessary details
- Update on European medical device regulations (EMDR)
- Manufacturers will be required to update the format of technical files, declarations of conformity, and labelling
- The new format requires manufacturers to create a summary document for each section instead of providing complete protocols and reports
- Common pitfalls in assembling a Technical File
- Compile the EU Technical File and ensure Format and Content expectations are addressed appropriately
- Determine exactly which materials need to be assembled
- Review all existing documentation in support of meeting the applicable Essential Requirements of the Directive(s)
- Determine applicable standards and address company-specific SOPs for constructing and managing your files
- European Norms and Standards and other documents supporting Technical Files and Design Dossier
This Webinar will provide a substantive overview and outlines how to prepare and construct the Technical File for those device firms dealing with the global regulatory landscape. The technical file is the key to a medical device's certification for CE marking because it contains the most important information about the device, how it works, how it is manufactured, and how it meets the applicable regulatory requirements. The Technical File is a comprehensive collection of information and documents that details everything about your medical device.
Understanding how to assemble this information and present the information properly is essential. If you manufacture a Class I device, a less complex CE Marking Technical File may be required. In the case of Class II a, II b and Class III devices, a more complex CE Technical File or Design Dossier must be prepared. EU Technical File construction is subject to review by a Notified Body if the medical device is Class I with measuring or sterile function, Class II a, II b, and III (Design Dossier). Once placed on the market, national Competent Authorities have the right to review EU Technical Files regardless of classification at any time. An incomplete or improperly completed Technical File may result in unexpected delays or even prevent market entry. Whereas the expression “Technical File” is usually associated with Class I, II a and II b, and “Design Dossier“ for class III products., the files are retained on the premises of the manufacturer or the Authorized Representative for potential review of Competent Authorities and Notified Body. Dossiers have to be submitted to the Notified Body for review prior CE-Marking of your product. It is not necessary to include all documents in the design dossier which have already been subject to an ISO/MDD type Audit by the Notified Body. Examples of documents not necessary to be included are Quality Manuals and related lower-level documents.
A brief summary of manufacturing processes (flow chart including inspection and preventive monitoring steps) and validation of sterilization processes should be included in the design dossier. Be prepared to review all elements that comprise these documents and address recommended best practices.
Who will Benefit
This webinar will provide valuable assistance and guidance to medical device companies responsible for constructing and managing their Technical File. Employees who will benefit include:
- All levels of management and departmental representatives and those who desire a better understanding or a "refresh" overview; however, it is assumed that customers/attendees have some prior MDD or IVD and CE Mark background as applicable
- Regulatory Affairs/Regulatory Affairs Specialists
- Clinical Affairs
- Quality and Compliance
- Marketing & Sales
- Engineering/Technical Services