CRED: Devices - Technical Documentation Requirements of the Medical Devices Directive

Aim:

This new one day CRED course on Medical Devices is intended to provide regulatory professionals with a thorough grounding in the requirements of the European Medical Devices Directives for “Technical Documentation”. Each presentation will include an interactive “mini-tutorial” where delegates are invited to provide opinions on the answers to questions on the topic and where guidance to possible answers will be given.

Who should attend:

This course is primarily intended for regulatory professionals working with Medical Devices - whatever their experience in this area. It will also be of interest to regulatory professionals working with other products and who wish to learn more about medical device requirements, as well as other professionals (e.g. in Clinical, R&D, Manufacturing, and QA) working with devices and who are involved in compiling “Technical Documentation”.

Course content:

Legal Background

• Legal purpose of technical documentation (including declaration of conformity); legal view on what is necessary / wise for technical documentation.
• Requirements from the medical device directives.
• CEC guidance to requirements (the blue book) and its legal status.
• Other guidance to requirements (standards and others) and its legal status.
• Other applicable legal requirements (e.g. product liability).
• Legal powers of regulators (and notified bodies) to review / inspect technical documentation.
• Legal view on what is ‘good’ and ‘bad’ technical documentation.
• Legal consequences when technical documentation is incomplete or inaccurate—role of the courts.

Compliance—Notified Body Perspective

• Notified Body expectations on the content / format of technical documentation.
• Notified Body review of technical documentation (when and how this happens and the consequences).
• What manufacturers should do to ensure the adequacy of their technical documentation

Compliance–Competent Authority Perspective

• MHRA expectations regarding the content / format of technical documentation.
• MHRA role in reviewing technical documentation (when, how this might happen and the consequences).
• How best to handle an MHRA inspection or request for technical documentation.

Content of technical documentation for investigational devices

• Requirements of technical documentation for standard devices (MDD) intended for clinical investigation including;
• Design and development information
• Demonstration of ER compliance
• Declarations of Conformity
• Applications to MHRA for approval of clinical investigations.
• MHRA process for reviewing applications for clinical investigations

Content of technical documentation for medical devices

• Technical requirements and format of technical documentation for ‘standard’ devices falling under the MDD.
• The ‘documentation’ to be addressed includes:
• Quality System documentation relating to a product
• Design and development Information
• Demonstration of ER compliance
• Certificates /Declarations of Compliance
• Post-market product experience
• Other documentation issues to be addressed include:
• Centralised documentation systems
• Decentralised documentation systems
• Guidance from Notified Bodies
• Maintaining technical documentation
• Results of internal audits

Content of technical documentation for IVDs

• Technical requirements and format of technical documentation for IVDs.
• The ‘documentation’ to be addressed includes:
• Performance evaluation procedures
• Standards and Common Technical Specifications (CTSs), including EDMA’s Involvement in CTS
• Labelling and Instructions for Use

Speakers:

Grant Castle, Partner, Covington & Burlington, UK
Neil Adams, Director, Operations and Delivery, BSI, UK
Bruce Petrie, MHRA, UK
Daniella Smolenska, MHRA, UK
Jane Hare, Wound Management Division, Smith& Nephew Medical Ltd, UK
Ben Jacoby, Manager, European Regulatory Affairs, Global Regulatory Systems, Ortho-Clinical Diagnostics, UK