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Related Experiment Videos

Achieving the CE mark: getting it right first time.

C Jepson1

  • 1SGS Yarsley ICS Ltd, Weston-super-Mare, UK. sgsprodcert@sgsgroup.com

Medical Device Technology
|August 5, 1997
PubMed
Summary
This summary is machine-generated.

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Manufacturers face CE marking delays due to documentation or procedural issues found during Notified Body audits. This article identifies common problem areas to help companies create a checklist and streamline their CE marking process.

Area of Science:

  • Medical device regulation
  • Quality management systems

Background:

  • Manufacturers frequently encounter delays in obtaining CE marking for medical devices post-audit.
  • Deficiencies in documentation and procedural adherence are primary reasons for these delays.
  • Notified Body audits are critical for ensuring compliance with regulatory standards.

Purpose of the Study:

  • To identify common problem areas encountered during Notified Body audits for medical device CE marking.
  • To provide manufacturers with actionable insights to prevent CE marking delays.
  • To serve as a checklist for manufacturers to improve their internal systems.

Main Methods:

  • Analysis of audit experiences from a Notified Body perspective.
  • Identification and categorization of recurring issues in manufacturer documentation and procedures.

Related Experiment Videos

  • Review of common non-compliance points leading to delayed CE marking.

    • Main Results:

    • Key problem areas include inadequate risk management files, insufficient clinical evaluation reports, and poor change control procedures.
    • Common procedural deficiencies involve lack of documented training, improper complaint handling, and inadequate post-market surveillance.
    • Documentation gaps often relate to incomplete technical documentation and non-adherence to relevant harmonized standards.

    Conclusions:

    • Addressing identified documentation and procedural deficiencies proactively can significantly reduce CE marking timelines.
    • Manufacturers should use audit findings as a guide to enhance their quality management systems.
    • Regular internal audits and system reviews are essential for maintaining compliance and avoiding regulatory delays.