| Regulatory Requirement | Document Section |
|---|---|
| MDR Annex I (General Safety and Performance Requirements), Annex IV (EU Declaration of Conformity), Art. 27, 29, 31 (UDI / Eudamed) | All |
| MPDG §8, §96, §97 | All |
| ISO 13485:2015, Sections 4.2.3 | All |
Overview
This SOP outlines the procedure for introducing a medical device to the market in compliance with relevant regulatory requirements, including the preparation of Technical Documentation and issuance of an EU Declaration of Conformity.
| Process Owner | \ |
| Key Performance Indicators | \ |
Process Steps
1. Initiating a New or Revised Medical Device
This process begins when Management decides to introduce a new or updated medical device. Potential sources of input include:
- Discussions with potential customers
- Market analysis
- Internal ideas
If applicable, a Product Manager is assigned to oversee the new device, collaborating with the QMO to determine the device’s classification according to the MDR Classification document.
| Participants | Management, Product Manager, QMO |
| Input | Management decision to launch a new device |
| Output | Completed medical device classification |
2. Conformity Assessment Application with Notified Body
Depending on the device’s classification, a Notified Body may be needed for conformity assessment.
NOTE: All medical devices, except those of class I, must undergo conformity assessment by a Notified Body.
| Participants | Product Manager |
| Input | Medical device classification |
| Output | Contract with Notified Body |
3. Preparation of Technical Documentation and Declaration of Conformity
Technical documentation is prepared by following the relevant development processes (e.g., software development, risk management, usability testing). The Product Manager coordinates this step with the necessary team members. Documentation for different device versions should be kept distinct.
The Product Manager maintains a Medical Devices List, as required by MDR Annex II Sec 1.2, which should include:
- Device versions installed at customer sites (if applicable)
- Previous versions, including release and decommissioning dates
- Similar devices
Before submitting to the Notified Body for assessment (if required), the QMO verifies the completeness of the documentation according to the criteria listed below. The MDR General Safety and Performance Requirements Checklist records compliance with EU regulations.
- MDR General Safety and Performance Requirements (Annex I)
- MDR EU Declaration of Conformity (Annex IV)
Once approved by the Notified Body, Management signs the EU Declaration of Conformity, marking the product version as released and available on the market.
| Participants | Product Manager, QMO |
| Input | Technical documentation |
| Output | Approval from Notified Body Signed EU Declaration of Conformity Updated Medical Devices List and Product Versions |
4. Medical Device Registration (UDI)
The Product Manager ensures compliance with country-specific registration requirements prior to market introduction. For Europe, Art. 29 and Annex VI of the MDR must be followed to register the device’s Unique Device Identifier (UDI) in the Eudamed database.
For changes to a product, a new UDI-DI must be applied if the changes include:
- Significant modifications as outlined in the Change Evaluation List
- Alterations in intended use
- New features or functions
- Changes in product interoperability, new interfaces, or connected systems
- Major changes to the user interface
- Support for a new operating system
- Adoption of a new programming language
- Introduction of a new algorithm model
- Significant changes to software or database architecture
For minor changes, the Product Manager assigns a new UDI-PI, which can include:
- Bug fixes
- Security updates
- Changes to user interfaces (focused on usability, excluding security)
The manufacturer determines the UDI-PI, with the device version number typically serving as the UDI-PI (refer to SOP Software Development).
NOTE:
- The Basic UDI-DI (BUDI-DI) is provided by UDI providers to identify groups of devices with similar risk classes, purposes, and designs.
- The UDI-DI is assigned by UDI providers for each product type and revised for significant changes.
- The UDI-PI is created by the manufacturer for each product and updated for minor changes.
Example:
- Basic UDI-DI: Wristband health monitoring device
- UDI-DI: Variations based on color and packaging (e.g., white/blue/red; single-/double-pack)
- UDI-PI: Variations based on series, batch, version, expiration date, etc.
Important Note: As of early 2021, the European Commission designated four entities (GS1, HIBCC, ICCBBA, and IFA) to issue UDI codes. Until Eudamed is fully operational, national registration requirements apply. For Germany, refer to §96 and §97 of the MPDG.
NOTE: For registration, authorities outside the EU may require translated documentation. Ensure compliance with relevant translation standards and regulations.
| Participants | Product Manager |
| Input | Released Declaration of Conformity |
| Output | Updated or new UDI, completed device registration |