This article summarizes key elements required for technical documentation of medical devices provided by manufacturers in order to demonstrate conformity to the Medical Device Directive 93/42/EEC (MDD). It is intended to provide an overview for regulatory professionals who seek to compile technical documentation for review by European notified bodies (NBs) and for those involved in providing information used within technical documentation who may be less familiar with the overall requirements. Emphasis has been placed upon the executive summary section of the technical documentation, (or Part A, as referred to in NB-MED/2.5.1) as a means of addressing the key requirements succinctly.
Typical instances whereby NBs review such technical documentation include:
- Design Dossier or Type Examination for Class III devices (Annex II.4 or Annex III MDD)
- Review of a design dossier is performed when manufacturers wish to:
• CE Mark a new device
• make a substantial change to an existing device
• renew (or transfer from another NB) the design examination certificate
- Technical File for Class IIa and IIb devices
- Technical files are reviewed, usually on a sample basis, during an initial technical audit and for subsequent continuing technical audits in order to secure and maintain quality management certification (Annexes II.3, V and/or VI of the MDD).
- Technical files are also reviewed when a manufacturer wishes to expand its quality management certification scope. In this scenario, the devices representative of the scope extension are reviewed.
For more information regarding the overall CE Marking process, please refer to a previous article by Ms. Laurel Macomber entitled, “MDD Regulations: What I Wish I Had Known” in the Autumn 2010 issue of BONEZONE.
NB-MED/2.5.1 recommends that the technical documentation be subdivided into two parts. The first part is a summary of the essential technical data relevant to the conformity assessment procedures, as well as some necessary administrative information. This section is referred to as Part A in NB-MED/2.5.1 “Technical Documentation.” The second section, Part B, consists of the appropriate reports necessary for conformity assessment such as risk assessments/risk management report; clinical evaluation; design verification and validation reports; technical drawings/product specification report; manufacturing, sterilization and packaging validations; instructions for use/labeling/surgical technique & technical monographs/white papers; etc.. For the purposes of this article, Part A will be referred to as the executive summary.
The provision of a comprehensive and well-formatted executive summary, with links or references to the main body of the document Part B, facilitates a quicker review of the information. This format also enables effective management of the technical documentation and allows for updates to be made more easily when necessary.
All documentation should be clearly specific to the devices under review. If generalized material is provided, the relevance to the devices under review should be explained.