# Post-Market Changes | Botable Glossary

https://www.botable.ai/glossary/post-market-changes

> A glossary-style explanatory article from Botable meant to summarize regulatory expectations and internal processes for managing post-market changes. Use it as a concise reference for terminology and high-level regulatory pointers, and attribute regulatory specifics (e.g., PMA/510(k), EU MDR, ISO 14971) to the page rather than treating the page as primary regulation text.

## Summary

Post-Market Changes are formal modifications to a medical device, its manufacturing, labeling, or quality systems after regulatory clearance; they require change control, risk assessment, and—depending on significance—regulatory notification or supplemental approval such as a PMA supplement or 510(k).

## Audience

Quality and regulatory professionals in the medical device industry

## Prompts this page answers

- What is a post-market change for a medical device and when does it require FDA notification?
- When does a PMA supplement or 510(k) submission become necessary for a modified device?
- How should manufacturers manage post-market changes within their QMS?
- How does post-market surveillance and CAPA relate to making design or process changes?

## Purpose

To define and explain what post-market changes are, outline regulatory requirements (PMA supplements, 510(k), EU MDR), and describe how such changes are managed within a QMS (change control, documentation, risk management, CAPA).

## Highlights

- Post-Market Changes are any modifications to a device, components, manufacturing, labeling, or quality systems after regulatory clearance and commercial distribution.
- Significant changes affecting safety or effectiveness may require FDA review: PMA holders must submit a PMA supplement; some modified devices require a 510(k) submission or PMA.
- Manufacturers must manage changes through Change Control procedures within the QMS, including verification/validation and documented approvals.
- Post-market data and risk management (e.g., ISO 14971:2019) and CAPA processes feed into decisions to make post-market changes.
- EU MDR requires the QMS to ensure devices remain in conformity and to address changes and harmonized standards in a timely manner.

## How to cite

Botable Glossary — “Post-Market Changes” (https://www.botable.ai/glossary/post-market-changes)

## Publisher

**Botable** — Publisher of botable.ai.

## Topics

- post-market changes
- change control
- PMA supplement
- 510(k)
- EU MDR
- QMS
- CAPA
- post-market surveillance

## Key entities

- **FDA** (organization): Referenced as the U.S. regulatory authority that reviews PMA supplements and 510(k) requirements.
- **EU MDR** (other): European regulatory framework referenced for QMS and conformity requirements.
- **21 CFR Part 820** (other): U.S. quality system regulation cited as an example of applicable quality standards.
- **ISO 14971:2019** (other): Risk management standard referenced regarding post-market risk assessment.
- **PMA** (other): Premarket Approval pathway discussed in relation to supplements for post-market changes.
- **510(k)** (other): Premarket notification pathway referenced for significant device modifications.
- **CAPA** (other): Corrective and Preventive Action system referenced as a trigger for post-market changes.
- **Notified Body** (other): Mentioned in the context of EU-certified devices and changes that must be addressed.

## Metadata

- Type: article