A design change is a change in the design of a device. It is important to understand when such a change is considered a significant design change because the regulatory authorities and notified bodies usually have to be informed of significant design changes and the device usually has to be re-authorized.
Manufacturers in Europe can no longer make use of the transitional periods established in Article 120 of the MDR when making a significant design change.
Manufacturers whose existing class I devices have to be reported to notified bodies for the first time under the MDR are also affected.
This article will explain to you which design changes are considered significant and help you avoid breaking medical device law, something which can even be punished by imprisonment!
Whenever something is changed in the design of a medical device, a design change is implemented.
Therefore, a design change is not (just) a change in the (visual) design of a device.
Rather, it is any change to the conceptual design of a device after its release, regardless of whether this change has to be reported or not.
Be aware that the MDR also considers a change in intended purpose as a design change, even when the device stays exactly the same.
We would also talk of a design change when the manufacturer changes:
If a software developer detects a bug during unit testing and then corrects it, this is not a design change. However, if they detect an error in the approved architecture and fix it (implicitly in the code and/or explicitly in the design document), a design change has taken place.
As we have already mentioned, the MDR also considers a change in the intended purpose, e.g., new indications or a different user group, to be a design change.
c) Relevant documents
In addition to system and software designs, design changes can also involve changes to mechanisms, electronics, materials and even the design input itself, including the intended purpose(!).
a) FDA design change requirements
The FDA has realized that solutions to problems often cause new problems. For this reason, they demand that manufacturers assess these “solutions” (changes) very carefully before implementing them.
More specifically 21 CFR § 820.30(i) “Design changes” states that:
Each manufacturer shall establish and maintain procedures for the identification, documentation, validation or where appropriate verification, review, and approval of design changes before their implementation.
To reiterate what the FDA says in this paragraph:
You can read more on the subject in the guidance document “Deciding When to Submit a 510(k) for a Change to an Existing Device”.
b) ISO 13485 regarding design and development changes
There are requirements as to how to handle design changes in Europe too. In section 7.3, ISO 13485 sets out how design and development changes should be managed.
The requirements are the same as the FDA's. So the changes must be:
The EU Medical Device Regulation (MDR) discusses design changes at several points, for example:
Design changes also play a role in the transitional arrangements:
By way of derogation from Article 5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph 2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues to comply with either of those Directives, and provided there are no significant changes in the design and intended purpose.
MDR, Article 120
Many manufacturers find it hard to assess when a design change is substantial and needs to be reported. This is one of the reasons the MDCG published Guideline 2020-03 (see below).
d) Health Canada
Although a little older, Health Canada's guidelines are still helpful, up-to-date and very comprehensive. The authority published the “GUIDANCE DOCUMENT for the Interpretation of Significant Change” back in 2011.
The flowcharts on IVDDs and on changes to manufacturing, facilities and labeling are particularly worth looking at.
a) NBOG guidance document
The Notified Body Operations Group (NBOG) has published a “Guidance for manufacturers and Notified Bodies on reporting of Design Changes and Changes of the Quality System” that aims to provide more clarity.
Here the authors explain when a design change should be considered substantial and must, therefore, be reported. Any change to a device that could influence conformity with the essential requirements or the scope of application or contraindications established by the manufacturer is considered a substantial change.
More specifically, the document mentions changes:
b) MDCG 2020-03
In March 2020, the MDCG published the guideline “MDCG 2020-03” entitled “Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD.”
The aim of this guideline is to clarify to manufacturers when a design change has to be reported and when it does not.
Design changes that do not have to be reported
The MDCG explains which design changes it deems do not have to be reported:
According to MDCG 202-03, manufacturers can obtain confirmation from notified bodies that a design change is not significant. However, this does not constitute the issuance of a “supplemented certificate.”
Design changes that have to be reported
The MDCG defines the following changes as “significant”:
A lot of software changes
By its very nature, the document leaves questions open. We would have liked answers to the following questions in particular:
c) Guidance from the notified bodies (NB-MED)
The document NB-MED/2.5.2/Rec2 contains concrete definitions and examples of reportable and non-reportable design changes.
d) CAMD FAQs
In its FAQ, the CAMD (Competent Authorities for Medical Devices) also addresses the question of when a design change is “significant.” However, the answer to question 17 does not really contain anything new that is not in the MDCG document.
e) Scope of the certificate
The scope of the certificate is also decisive. If you want to modify your device that you have placed on the market via Annex II of the MDD or Annex IX of the MDR in a way that means it no longer falls within the scope of these annexes, you cannot do this without involving the notified body.
The certificates only allow you as a manufacturer to develop and place on the market (without asking the notified body for permission) devices within the certificates. However, notified bodies often request to be informed.
This chapter summarizes the legal requirements and guidelines for software.
Software design changes that have to be reported
A software design change would presumably have to be reported under one of the following conditions:
Software design changes that do not have to be reported
Usually, the following changes to software do not have to be reported:
The Johner Institute recommends making clear arrangements with your notified body. The aim of the above list is to help you with this. The free micro-consulting service is available to a limited extent to manufacturers, regulatory authorities and notified bodies for such assessments.
The differentiation the MDR and IVDR make between software changes that require a change to the UDI-DI and those that “only” require a change to the UDI-PI may be useful for helping you decide what is a reportable change and what is a non-reportable change. A change in the UDI-PI does not usually have to be reported.
With its document 2020-03, the MDCG provides a good tool for differentiating between significant and non-significant design changes.
In a second version of the document the authors should
The extent to which manufacturers and notified bodies adhere to the MDCG's specifications remains to be seen. Sometimes, as a consequence of both sides being overloaded, there seems to be a tacit agreement that a design change is non-significant.
The large number of regulatory requirements means that global harmonization would be very welcome.