MDR Significant Changes for Medical Devices

What is a product significant change?

The manufacturers should carefully read MDCG 2020-3 – Guidance on significant changes regarding the transitional provision under Article 120 of the MDR concerning devices covered by certificates according to MDD or AIMDD.

As per Article 120 of MDR or Article 110 of Regulation 2017/746 (IVDR), we already mentioned that no significant changes in the design or intended device purpose are allowed after the DoA.

Implementing such a change would prevent the manufacturer from placing that device on the market under the Directives. In other words, such change would require upgrading certification from MDD/AIMDD to EU MDR.

Therefore, when considering any change in the product, the manufacturer should analyze whether such change may affect the design or the intended purpose of the device. In case of doubt, the manufacturer should consult their notified body. For, e.g., switching from the QMS documentation system, which contains paper (hardcopy) and to entirely electronic (paperless) records and signatures might be considered significant (as per NBOG 2014-3) but in some scenarios may not. The change of manufacturer, an importer, must be assessed on a case-to-case basis.

Product changes and QMS

The process of change assessment should be described in the company Quality Management System (QMS) and reflected in its relevant procedures such as:

• Strategy for regulatory compliance
• Reporting/notification of significant changes
• Notification procedure between the manufacturer and Notified Body
• Product configuration/engineering changes
• Change control
• Design control or
• Other methods, as applicable

MDCG 2020-3 guidance provides helpful flowcharts to facilitate a harmonized judgment of the significance of changes.

Significant Changes

Intended use changes

• change of intended use or its extension (other than limitation),
• new patient/user population (other than more limited target population),
• change in clinical use (e.g., change in anatomical/access site)

 Design/performance specification changes

• changes that require additional usability or clinical data to support performance or safety,
• occurrence of new risks which require mitigation or negatively impact existing risks,
• change in built-in controls,
• change in operating principle, mode of action, source of energy or alarms,
• changes that make a device more challenging to sterilize

 Material changes

• any changes to materials of human or animal origin,
• any changes to medicinal substances included in the product,
• new suppliers for product material or ingredient where the new specifications which do not meet existing ingredient specifications,
• sterilization changes, such as changes in sterilization method (including a shift from non-sterile to sterile status) or sterility assurance level,
• changes in a sterile device’s packaging design affecting functionality, safety, stability, or seal integrity

Software changes

• changes of the operating system or any component,
• new or modified architecture/database structure/algorithm,
• user-input replaced by a closed-loop algorithm,
• new diagnostic/therapeutic feature,
• new channel of interoperability (e.g., exporting data from a device to the cloud),
• a new user interface,
• a new presentation of medical data (e.g., in a new format, dimension, or measuring unit)

Non-Significant Changes

 

 

 

 

 

 

 

 

 

 

 

Non-significant changes are changes that do not impact the design or the intended purpose of the device (as per the meaning of the MDR Article 120(3)). Thus, MDR allows the implementation of such a change during the transitional period.

Not requiring notification to Notified Bodies

Here are some examples of non-significant changes which doesn’t require notification to the Notified Body:

• administrative changes such as manufacturer’s name, address, or
• change of the Authorised Representative.

Requiring notification to Notified Bodies

Unlike administrative changes, the changes listed below would require notification to the Notified Body:

• relocation or addition of new manufacturing site (incl. for subcontractors and suppliers),
• changes to the quality management system, which does not affect the conformity assessment certification conditions,
• the change related to corrective actions that have been assessed and accepted by the relevant competent authority (even if they include significant for, e.g., design change)

The manufacturer should always prove that all the changes mentioned above do not affect the design or the intended purpose.

Verification of Changes

Non-Class I devices

Notified Bodies will verify changes and their implementation for devices other than Class I, at audits or upon change notification submissions. In addition, the Notified Body will determine whether an existing MDD/AIMDD certificate remains valid or there is a need for a new EU MDR certificate.

After reviewing the manufacturer’s description of the change, the notified body may confirm in writing that the implementation of the change does not represent a significant change in design or intended purpose under MDR Article 120(3) and that the related AIMDD or MDD certificate remains valid. Such written confirmation complements information on an existing certificate but does not represent the issuance of an updated certificate. In case of requests from authorities, the manufacturer should number such letters received from the notified body and submit them together with the certificate.

Class I devices

Manufacturers of Class I devices requiring Notified Body involvement under the EU MDR should document their decision and its rationale related to changes, keep them in their company documentation, and make them available to the competent authorities when requested.

Questions & Answers

Question: One company asked whether a change of the product name would be allowed in the transitional period and whether such a change would be considered significant. A device is a legacy device under MDD, preparing for MDR transition.

Answer: MDCG 2020-3 Rev.1 lists an example of a name change of the manufacturer, not the product itself. However, the same guidance states in 4.2 (Changes not concerning the design or intended purpose) that: Changes concerning the manufacturer’s organisation (administrative changes) or changes concerning the manufacturing process should generally not be considered changes in the design or intended purpose within the meaning of Article 120(3c), point (b) MDR, even if they need to be reflected in the information to be supplied with the device (e.g. label or instructions for use).

Based on this, we advised the company that it is possible to change product ame, but they should speak with their Notified Body in advance.

Question: Could we use our distributor name and brand on the label and still remain legal manufacturer?

Answer: Yes, this scenario is possible. According to MDR Article 16, obligations of manufacturers apply to distributors when the distributor makes available on the market a device under its name, registered trade name, or registered trademark, except in cases where a distributor… enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers according to MDR. We can help you to draft such agreement with your brand partner.

Question: What is included in significant changes related to design?

Answer: See charts B to E in MDCG 2020-3

• Change of performance characteristics and limitations
• Change of materials/components
• Change of medicinal substances/tissues or cells of animal origin
• Change of accessories
• Change of built-in control mechanism
• Change of hardware, software/operating system/algorithms
• Change of sterilization procedure
• Change of stability /shelf life/packaging/transport stability & more

Question: The company outside the EU has two Authorized Representatives (ARs) for two different generic groups of devices. Could we assign both ARs to our manufacturer registration?

Answer: The Actor Module FAQs (4.2.2) from 2022 state that for registration of a non-EU manufacturer, only one authorized representative of their choice must be selected from those already registered (with an SRN) in EUDAMED.

BioReg Services & MDD-MDR transition

In one of our previous posts, we explained that it would be wise to start preparing for the MDR audit on time – see here why.

The manufacturer should use the transitional (grace) period to undertake an MDD to MDR gap analysis of the technical documentation for the product.

Most companies will need to work on their PMS plan, PMCF plan, PMS report and PMCF evaluation report. We described the basic requirements for each of these documents in our recent blog.

The clinical evaluations should be compliant with MEDDEV 2.7/1, rev. 4. Most companies will need to update their Clinical Evaluation plan and the Clinical Evaluation Report (CER). Manufacturers of up-classified devices now have the opportunity to collect real-life data from the use of their devices and use that information as clinical evidence. For a full explanation of the clinical evaluation procedure, please refer to our previous blogs:

31 Tips for Successful MDR Clinical Evaluation & CER and Medical device clinical evaluation according to new MDR Medical Device Regulation.

If you plan to write your Clinical Evaluation Report (CER) and don’t know how to start – we advise you to use our CER template, which could be easily customized to your product – see here.

Contact Us!

If you wish to inquire about product classification, MDR significant changes, or any other issue – BioReg is here for you. Please feel free to schedule an MDR 1hour consulting session (discounted).

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