When looking at many QM manuals in the MedTech sector, one thing is always noticeable: The process for change control exists but is seen as a fifth wheel on the wagon. Superfluous, complicated and an obstacle to rapid market access. But is this really the case? However, with a well thought-out and practised change management process, you create one thing above all: consistently compliant products that do not cause any nasty surprises down the line.
These are the guidelines to follow when it comes to change management
The question often arises as to where the requirements for change management are described at all. The answer is: in various places and the interpretation is of course always dependent on the respective manufacturer. Basically, there are requirements for changes to both, products and processes.
The most common and best established procedures concern changes to products, which are usually located in the area of development. This specification comes first of all from DIN EN ISO 13485:2021″.
- 7.3.9 Control of design and development changes”.
However, according to DIN EN ISO 13485:2021, it is also necessary to evaluate changes to processes. This is described in various chapters of the standard:
- 4.1 General requirements, section 4.1.4 in particular
- 4.2.4 Control of documents
- 5.4.2 Quality management system planning
- 5.6 Management review
- 7.2.2 Review of requirements related to product
- 7.2.3 Communication
- 7.4.2 Purchasing information
- 7.4.3 Verification of purchased products
- 7.5.6 Validation of processes for production and service provision
And not to forget, changes that become necessary within the framework of quality management according to chapter
- 8.5.2 Corrective action
- 8.5.3 Preventive action
“necessary planning and documentation measures and implementation of such actions, including, as necessary, updating the documentation;”
Within the framework of the MDR and IVDR, change management is mentioned in two places. The first, rather general, requirement is found in Article 10 under the manufacturers’ obligations:
- The quality management system shall address at least the following aspects:
a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;
However, most manufacturers are not familiar with the requirements described in Annex VII, which are imposed on the notified body as a test criterion. They are required to check the correct implementation at the manufacturers’ site according to the following criteria:
- 9 Changes and modifications
The notified body shall have documented procedures and contractual agreements with manufacturers in place relating to the manufacturers’ information obligations and the assessment of changes to:
- the approved quality management system or systems or the product-range covered,
- the approved design of a device,
[…]
In accordance with its documented procedures, the notified body in question shall:
- ensure that manufacturers submit for prior approval plans for changes referred to in the first paragraph and relevant information relating to such changes,
[…]
Those looking for more clues should turn to the requirements for the allocation of a new UDI
In addition, the MDCG guidances
- MDCG 2020-3 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
- MDCG 2022-6 Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
provide important clues. We will deal with these in the further course of this article, but for now they are mentioned here for the sake of completeness.
Minor Change, major Change, non-significant or significant?
Changes are usually divided into two “classes”:
- Changes that have only a minor impact on the product or processes à usually referred to as “minor” or “non-significant”.
- Changes that have a strong impact on the product or processes à usually referred to as “major” or “significant”.
Why is this classification important? Because major / significant changes usually have to be approved in advance by the respective authorities or notified bodies, they delay the market access of the changed product / the product affected by the change in the process. Therefore, many manufacturers tend to document changes in a rather small manner. Minor/non-significant changes usually only require documentation within the QM system and possibly a general notification without prior approval, e.g., during the audit.
For Europe, there is no guidance document published directly under the MDR/IVDR that can be used for classification. However, there are guidance documents that can be used as a basis for decision-making. On the one hand, it can be referred to the already mentioned MDCG Guidances on the classification of permissible changes within the framework of the transition periods from MDD/IVDD to MDR/IVDR in order to also classify a change in principle. If, according to MDCG 2020-3/2022-6, it falls within the range so that the product/process would no longer benefit from the transition period after the change, but a renewed conformity would have to be declared, the change would also be classified as “major” / “significant” for pure MDR/IVDR products. If the change would still benefit from the transition period, a classification as “minor” / “non-significant” can be well justified. But beware, there is a disclaimer from the MDCG:
This guidance document does not elaborate on the process for manufacturers’ submission and notified bodies’ assessment of changes to the approved design or substantial changes to the approved quality system or to the product-range covered.
So, for those for whom these guides still offer too little potential for classification, the guide already published under MDD, AIMD and IVDD
which was also adopted one-to-one by the ZLG as EK Med 3.9 B31 can be very helpful. The MDCG guidelines on the classification of changes during the transitional periods, which have already been explained, also refer to it.
Outside Europe, there are clear decision-making guides that can be referred to for the respective target countries. Some examples would be:
- Saudi Arabia: MDS – G012 Guidance on MDMA – Significant and Non-Significant Changes
- FDA: Deciding When to Submit a 510(k) for a Change to an Existing Device
- Canada: Guidance for the Interpretation of Significant Change of a Medical Device
The important thing with regard to Europe: Define criteria according to which you carry out the classification (e.g., according to the MDCG guidelines), present these in the audit and then act consistently according to them.
MDCG 2020-3 after revision 1 – the changes in detail
The MDCG Guide 20203-3 “
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 ” was first published in March 2020. Revision 1 has been available since May 2023. It refers to Article 120 (3c), point (b) of the MDR. But what are the concrete changes between the two revisions? Well, it is worth taking a look and to be prepared for some surprises.
First of all, an explanation of what exactly a legacy device is and which transition periods apply on the basis of Regulation (EU) 2023/607 can be found in the introductory chapter 1.
In Chapter 4, the description “significant according to MDR Article 120(3c)” is explained in detail, and information is provided on which types of changes to the design and/or intended use are considered significant or non-significant with regard to the transitional periods – in some cases also with surprising findings. These in particular should be taken as an opportunity to consult the Notified Body again if the Guideline is to be used as a decision-making aid for “minor” and “major” classifications. As a general rule, even if a change was initially classified as non-significant, it should be finally reviewed again, as there could always be aspects that turn out to be relevant in the course of the change.
The following changes were made in the charts themselves:
- Main Chart: slight changes in the order, addition of subtleties, e.g., that when changes are made to the packaging or sterilisation method, a possible influence on shelf life must also be assessed.
- Chart A: Intended Purpose. Basically, the chart has remained the same. The entry in box A4 has been reworded from “Change of clinical use” to “New way of clinical application”.
- Chart B: Only deals with “Change of the Design” and no longer with the “Performance Specifications”. Accordingly, the chart is shorter and there is a focus on changes to integrated control mechanisms, the operating principle, the source of energy or the alarm systems.
- Chart C Software. The chart has remained largely the same. The points from C4 and C5 have been bundled under C4 and deal with new user interfaces, new types of presentation of data or additional medical features.
- Chart D: Substances and materials. In this chart, the entries from boxes D3 and D4 have been changed. The focus is placed on surgically invasive devices with contact over 30 days.
- Chart E: Sterilisation. The chart is only slightly modified. Mainly some examples were transferred to the text sections of chapter 4.
The conclusion to revision 1 is: especially the explanations and the examples from chapter 4 should be read. It is not advisable to rush directly to the decision trees and only read these. The document must be read and understood in its entirety. The final question for classifying changes as “minor” or “major” always remains: Does the change have an impact on the safety and performance of the product? And does the risk-benefit balance remain or is it negatively affected?
Sources of change
As mentioned at the beginning, the need for change management and change requests is often only recognised in the case of significant changes to products. But change management is relevant for many more cases and forms an important building block to ensure that products, product files, internal processes and evidence for the stability of the processes are given.
There are many potential sources of change, for example:
- Regulatory requirements – new & amended standards, laws, guidelines
- Purchasing – changes to specifications, materials, sources of supply
- Management review – findings from the internal management review
- Production – potential for improvement or necessary parameter adjustments
- Non-conformities and CAPAs
- Post-market surveillance activities
- And potentially any process in the QM system that could have an impact on the quality and performance of the products
It is often underestimated what influence a small change in a normatively required limit value, a set parameter on the machine or a changed product dimension can have.
In case of doubt: the need to assess the General Safety and Performance Requirements for the products covered by the changes and to issue a new Declaration of Conformity.
It is therefore important to raise the awareness of all employees in the company for the topic of change management and to win them over to it through a lean process.
Image: Changes come from many corners and also influence many areas of the medical device manufacturer.
What to consider when implementing changes
Basically, it is always important to look at a change holistically. This should not be done by a single employee, but by an interdisciplinary team that looks at the change from different perspectives. Relevant aspects can be, for example, the following:
- Doesn’t changing the process also affect the safety and performance of some products?
- And don’t I then also have to update their technical documentation?
- Do I need a new UDI-DI due to my change, as my product model is significantly different from the previous one?
- Have I really considered all the countries to which I ship my products?
- How do I deal with remaining stocks and starting from when does my change become valid at all?
- Is my previous declaration of conformity still valid at all?
Perceived truths around change management
When the topic of “change management” comes up, there is often a lot of eye-rolling. Unfortunately, change management is still seen as a brake rather than a motor. Certainly, a well-positioned change management means more work at first. Especially more preparatory work. However, once the decision has been made properly and all relevant information, costs and necessary resources are on the table, a change can be approached and implemented in a more structured way. If the process is not (accurately) lived, it may seem that changes are implemented so much faster, but this carries two risks: unsafe, non-compliant products are delivered, which in the worst case leave dissatisfied customers and injured patients. And the costs and efforts to become compliant again are there but hidden behind the costs that exist “anyway”.
If the change management itself is running, however, changes are often documented in a “small” way so that they do not end up in the area of major/significant changes. Until it comes to promoting the change, because who doesn’t like to be innovative? But this painful realisation must be endured: if the change is only minor, it will probably not bring about a major innovation, but it will also reach the market more quickly. If the change is extensive and requires a lot of resources and time to be implemented correctly, it can probably be promoted as innovative.
And last but not least: no matter how well your change management is set up, at the end of the day it is important that all employees of the company have understood the importance of the process and actively live it. Only when changes are officially introduced into the process, they can be implemented correctly. And this already starts with the change of a source of supply or the setting of a minimum manufacturing parameter.
Are you still afraid of changing your change management? Do you still lack the persuasiveness of all your colleagues? Or would you like a neutral, external view? We are happy to help you get a grip on your changes so that you can soon devote yourself to other things again.
Please note that all details and listings do not claim to be complete, are without guarantee and are for information purposes only.
