| Regulatory Requirement | Document Section |
|---|---|
| ISO 13485:2016 Sections 5.6.2 and 7.3.3 | All |
Summary
This SOP outlines the procedure for identifying regulatory changes that apply to the organization as a manufacturer or to its market products. The process is designed to ensure that any necessary updates are recognized early and incorporated promptly to maintain continuous regulatory compliance.
| Process Owner | \ |
| Key Performance Indicators | \ |
Process Steps
1. Regulatory Input / Review
The QMO is tasked with collecting all relevant regulatory information that may impact the organization and its medical devices, using documentation provided by the Product Manager(s). This information may include statutory laws, regulations, and guidance documents. The QMO assesses the relevance of these regulations and records the findings in a List of Regulatory Requirements.
Potential sources for regulatory input include, but are not limited to:
* ISO / IEC newsletters
* Beuth newsletter (for Germany)
* FDA newsletter
* EU website for harmonized standards
* Consultative newsletters
Each relevant regulation must be reviewed at least annually, before the introduction of a new medical device to the market, or as outlined in the List of Regulatory Requirements.
| Participants | QMO |
| Input | Medical device specifications (technical documentation), regulatory requirement documents |
| Output | List of Regulatory Requirements |
2. Addressing Changes Due to Regulations
When a new or updated regulation is identified, the QMO conducts a gap analysis to determine if:
- Modifications are needed within the organization,
- Adjustments are required in the quality management system,
- Changes are necessary for any medical devices,
to ensure alignment with the updated regulations. The results of this gap analysis are stored in the QMS records for audit purposes. The QMO updates the List of Regulatory Requirements as needed.
Any necessary changes to medical devices are carried out following the change management process. The QMO either implements updates to the quality management system or delegates this task to the appropriate process owners.
| Participants | QMO, Process owners |
| Input | New or updated regulations |
| Output | Gap analysis report, updated List of Regulatory Requirements |
3. Communication and Evaluation of Changes
The QMO is responsible for communicating any new or updated regulations to relevant organizational members, such as process owners and product managers. Management is updated on new or revised regulations at least once a year during the Management Review. The effectiveness of implementing these updates is also assessed during the Management Review.
| Participants | QMO, Management |
| Input | Changes implemented in response to new or updated regulations |
| Output | Communication to relevant team members, Management Review Report including evaluation of regulatory updates implementation |