We assess changes to medical devices and IVD: notified body approval under MDR or IVDR, new 510(k) or letter to file in the US. What a change costs is settled when it is classified as significant or not, before anyone implements it.
Overview
Change assessment for medical devices and IVD · MDR and IVDR Annexes VII, IX and X · 21 CFR 807.81(a)(3) and 21 CFR 814.39 · FDA guidance on device and software changes
Last updated: October 28, 2026
Most changes to a certified device can be made without a new conformity assessment. The cost comes from the changes that were classified late, one at a time, or against the wrong criteria.
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Classifying each planned change against the criteria that apply to the device: MDR or IVDR Annex IX or Annex X for certified devices, 21 CFR 807.81(a)(3) and the FDA flowcharts for cleared devices, with the rationale written down. Deliverable: a signed assessment per change that states its regulatory consequence.
Preparing the notification of a planned change: what changes, which parts of the technical documentation are affected, the verification and validation evidence and the proposed classification. Deliverable: a notification package in the form the notified body's procedure asks for.
A step in the change procedure that sends every change to the regulatory assessment before release, with criteria, responsibilities and the link to the notification procedure agreed with the notified body. Deliverable: SOP section and assessment form.
Assessing a change once for the EU and the US. The criteria are worded differently, so the same change can need the notified body's approval in one market and a documented assessment in the other. Deliverable: a joint assessment with one outcome per market.
How we work together
A change to a certified device ends in one of three places: an internal change with a documented rationale, a change the notified body has to approve before release, or a change that reopens the conformity assessment. Which one applies depends on the certificate and on the market.
Under the MDR, the test depends on the conformity assessment route. Annex IX Section 4.10 covers devices with an EU technical documentation assessment certificate, which on the Annex IX route means class III and the class IIb implantable devices under the second subparagraph of Art. 52(4): changes that could affect safety and performance or the conditions prescribed for use need approval, and the notified body decides between a supplement and a new conformity assessment.
For class IIa and the other class IIb devices, Art. 52(4) and (6) provide for an assessment of the technical documentation of representative devices. Their changes go through the notified body's change procedure under Annex VII Section 4.9. Type-examined devices have their own test in Annex X Section 5.2: changes that may affect conformity with the general safety and performance requirements or with the conditions prescribed for use.
The IVDR uses the same wording in Annex IX Section 4.11 and adds a consultation of the EU reference laboratory where a change could affect compliance with the common specifications; type examination follows Annex X Section 5. In both regulations, Annex IX Section 2.4 covers plans for substantial changes to the quality management system or the device range, and the notified body decides whether they need additional audits.
In the US, the threshold is 21 CFR 807.81(a)(3): a new 510(k) when a change could significantly affect safety or effectiveness, or when the intended use changes in a major way. Two FDA guidance documents, one for software, work through it with flowcharts. For PMA devices, 21 CFR 814.39 governs supplements.
| EU, technical documentation assessment certificate | US, 510(k) or De Novo device | US, PMA device | |
|---|---|---|---|
| Test | could affect safety and performance or the conditions prescribed for use | could significantly affect safety or effectiveness, or a major change in intended use | affects safety or effectiveness |
| Who decides | the notified body that issued the certificate | the manufacturer, documented; the FDA if a new 510(k) is filed | the PMA holder first; the FDA on a supplement or a 30-day notice |
| Outcome | supplement to the certificate or new conformity assessment | documented assessment or new 510(k) | PMA supplement, 30-day notice or periodic report |
One route is planned in advance: a change consistent with a cleared predetermined change control plan (PCCP) under section 515C of the FD&C Act needs no new 510(k) (21 CFR 807.81(b)(1)(ii)).
Two neighboring topics sit outside this page: the QMS change process under ISO 13485:2016 Section 7.3.9, and the significant-change test for legacy devices during the MDR and IVDR transition.
Our approach
Step
Result
Describe the change
A change description that names the affected design outputs, labeling, software and processes, compared with the certified or cleared state.
Classify
An outcome per market with its rationale: internal with documentation, notification to the notified body, new conformity assessment, new 510(k) or PMA supplement.
Notify or file
A notification package or submission that matches the notified body's procedure or the FDA route.
Release
Release only after the notified body's decision or the FDA's clearance where one is needed, and a file that shows the order.
Common pitfalls
The assessment is a ticked flowchart.
Appendix B of the FDA guidance states that highlighting the flowcharts or answering yes or no without further justification is not sufficient documentation.
Labeling and instructions for use are treated as editorial.
The FDA guidance gives labeling changes their own flowchart, and where MDR Annex IX Section 4.10 applies, a change that could affect the conditions prescribed for use needs the notified body's approval.
Software updates go out as maintenance releases without an assessment.
The FDA publishes a separate guidance for software changes to 510(k) devices, and under the MDR the question for software is the same as for hardware.
An extension of the intended purpose is handled like a design change.
Under MDR Annex X Section 5.3, changes to the intended purpose and conditions of use of a type-examined device, except limitations, need a new application for conformity assessment.
The assessment is not revisited.
The FDA guidance asks manufacturers to re-evaluate a change when the assumptions behind the first assessment do not hold, and to document the update.
Regulatory Affairs
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
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Latest insights
All insights →MDR Conformity →
Certification under the MDR, the state every later change is measured against
IVD Consulting & IVDR Readiness →
Certification of in vitro diagnostics under EU 2017/746
FDA Strategy & Pathways →
The 510(k), De Novo or PMA that a change is compared with
Design Controls →
Design changes inside the QMS, with verification, validation and release
Change Management →
Change control under GMP and ICH Q10, with variations for medicinal products
Briefly outline your situation. We'll respond with an initial assessment, usually within one business day.
Prefer direct? +41 61 271 23 80
info@theentourage.ch
