Definition of a Significant Change

The definition of a significant change to the design or intended purpose includes two cumulative elements:

  • there is a change in the design or intended purpose, and
  • the change is considered significant.

This term is not defined in the MDR, so manufacturers must rely on MDCG 2020-3 rev.1 guidance.

Any changes that do not impact the design or intended purpose fall outside the scope of MDR. Likewise, changes that do affect the design or intended purpose are only covered by MDR if they are considered “significant.” Changes intended to comply with other EU legislation are also excluded—unless they negatively affect the benefit-risk ratio of the device.

The Role of Significant Change Assessment in Regulatory Compliance

Assessing whether a change is significant is a key element of regulatory compliance under Regulation (EU) 2017/745 (MDR). Correct classification of a change determines whether a new conformity assessment by the notified body is required, thus ensuring continued market access.

Incorrect classification may result in loss of CE certification, non-compliance, and product withdrawal.

Significant Changes and MDR Transitional Provisions

Article 120 of the MDR introduced transitional provisions for devices certified under MDD/AIMDD. Class III and implantable Class IIb devices may remain on the market until 31 December 2027; other eligible devices until 31 December 2028.

To benefit from the transition, manufacturers must demonstrate that no significant changes were made to design or intended purpose, maintain compliance with MDD, and ensure no unacceptable risk to patients.

Who Determines Whether a Change Is Significant?

The manufacturer is responsible for analyzing the impact of the change on design and intended purpose. For devices above Class I, the change must be reported to the notified body with justification.

Stages of Change Assessment

  1. Change identification – scope, nature, and potential impact on safety or performance.
  2. Impact analysis – evaluation of functionality, MDR compliance, and technical documentation.
  3. Classification – comparison with MDCG 2020-3 and documentation of rationale.
  4. Verification – submission and review by the notified body.
  5. Implementation – technical file update, additional testing, conformity reassessment if needed.

Role of the Notified Body in Assessing Significant Changes

During the transitional period, the notified body evaluates whether a change affects the device’s design or intended purpose. If not, the MDD/AIMDD certificate remains valid. Otherwise, MDR recertification may be required.

Required Actions During Significant Change Management

Manufacturers should update their change management procedures, lifecycle documentation, surveillance protocols, and communication plans with the notified body. Each change must be assessed on a case-by-case basis, even if similar examples are found in MDCG 2020-3 rev.1.

Consequences of Non-Compliance with MDR Change Requirements

Improper change management can lead to:

  • loss of CE certificate,
  • market withdrawal in the EU,
  • administrative penalties and legal risk,
  • reputational damage and need for urgent CAPA.

Changes to the Manufacturer or EU Authorized Representative

Changes to the certificate holder, manufacturer, or EU authorised representative may require prior approval by the notified body. Updated registration data, contractual documentation, and legal continuity must be demonstrated.

Manufacturing Process Changes and Significant Impact

Changes such as relocating the manufacturing site, switching suppliers, or modifying production methods can affect device safety or performance. If they impact compliance with MDR essential requirements, they must be reported to the notified body.

Documentation Supporting Non-Significant Change

If a change is deemed non-significant, the manufacturer should:

  • prepare a justification document (e.g. non-significant change memo),
  • log the change in internal records,
  • document the impact on risk analysis and performance data.

Impact of a Significant Change on UDI and EUDAMED

Significant changes may require updates to the UDI-DI and corresponding records in EUDAMED. Failure to update regulatory data may result in enforcement actions and a halt in EU market access.

How Pure Clinical Supports Significant Change Assessment

Pure Clinical helps manufacturers by:

  • evaluating changes under MDR conformity requirements,
  • updating technical documentation and justifications,
  • supporting communication with notified bodies,
  • integrating change control into the quality system.

Our expertise covers MDD, AIMDD, and MDR-certified devices, including legacy device transitions.

FAQ

Is every material change in a medical device considered significant?

No. A material change is not necessarily significant if it does not affect biocompatibility, mechanical performance, or clinical function. However, impact must be assessed and documented.

Can packaging modifications be considered significant changes?

Yes, if they affect sterility, transport conditions, or shelf life. Marketing-related updates (e.g. label design) are generally not considered significant.

Is a change in risk classification under MDR automatically a significant change?

Yes. Reclassification triggers a full conformity assessment and cannot be treated under legacy certificate rules.