The Medical Devices Coordination Group (MDCG), an advisory body of the European Commission, issued a guidance document dedicated to the significant changes to medical devices subject to regulation under the Medical Devices Directive 93/42/EEC (MDD) or Active Implantable Medical Devices Directive 90/385/EEC (AIMD) with regard to the transitional provisions of the Medical Devices Regulation 2017/745 (MDR).
MDD and AIMD Application: General Approach
In order to simplify the transition to the new regulatory framework, reduce regulatory burden and avoid shortages in supply, which ensure the availability of medical devices on the market, the new Medical Device Regulation 2017/745 (MDR) allows medical devices certified under the Directives (MDD and AIMD) to be placed on the market. Such devices could be placed on the market before May 26, 2024 under one important condition – no significant changes should be made to such devices in the means of design and their intended purpose after the application date of the new regulation. That is why the MDCG finds it necessary to clarify all the aspects related to significant changes to assist medical device manufacturers in maintaining their compliance with this requirement. In case of minor changes, the certificates issued by the notified bodies (NB) under the AIMD and MDD frameworks remain valid, while the appropriate notified body should duly perform the surveillance required by the applicable regulation. If the notified body is no longer eligible to maintain the validity of the certificate, the provisions on orphaned medical devices should be applied, allowing the manufacturer to transfer the certificate to another notified body with the appropriate scope of designation.
Thus, the document is intended to provide medical device manufacturers and other parties involved in operations with medical devices with the necessary clarification regarding the way the provision on significant changes set forth by the Article 120(3) of the MDR should be applied.
Changes to MDD/AIMD Certificates
According to the new regulatory framework, issuing new, modified, amended or supplemented certificates under the Directives is no longer available. If the manufacturer would make changes to its device that would meet the criteria of significant changes, the possibility to place such medical devices on the market on the basis of existing MDD/AIMD certificate would no longer be available.
Changes Significance Determination
In accordance with applicable regulations, the relationships between the medical device manufacturer and the notified body responsible for conformity assessment and future surveillance regarding the particular medical device are based on the appropriate agreement concluded between these parties. Such an agreement includes an integral part of the provisions regulating the notification procedures – the way the manufacturer of the device shall duly inform the notified body about the changes made to the device. According to such provisions, depending on the significance of changes they should be approved either upon the appropriate submission filed by the manufacturer or through verification performed by the notified body in the course of the surveillance process. This verification is intended to confirm that the certificate issued under the MDD/AIMD framework remains valid. To maintain its validity, the manufacturers of the devices should refrain from making significant changes to the devices and discuss the planned changes with the notified body in case of any doubts. Changes covered by this requirements are mostly related to significant changes in design or intended purpose, while changes in the organizational structure of the manufacturer, such as any changes to its name, address or legal form, as well as an appointment of another authorized representative would not be deemed significant and impact the validity of the MDD/AIMD certificate. Thus, any changes other than related to the design or intended purpose should be determined as not significant. For instance, certain changes to the manufacturing facilities or quality management system do not impact the validity of the certificates. However, the manufacturer shall duly inform the notified body about such changes and agree them when necessary. The notified body is also entitled to require medical device manufacturers to provide confirmation that such changes do not impact the design of the device or its intended purpose. At the same time, in case of any doubts, the determination should be based on the additional assessment. If the change would be determined as not significant, the manufacturer would be allowed to implement it without the necessity to amend the certificates. The written statement issued by the appropriate notified body upon the review of change submission filed by the manufacturer would constitute confirmation of compliance with then applicable requirements and could be provided to the regulating authorities upon request.
If the continuous involvement of the notified body is not required due to the type of the device (for example, for Class I low risk medical devices subject to notification procedure), the manufacturer should prepare justification confirming that the changes do not impact the design and intended purpose of the device and be able to provide the proper documentation upon request.
Change Determination Process in Detail
To assist all parties involved in application of the provisions and rules described hereinabove, the MDCG supplemented the guidance with the flowcharts highlighting core aspects.
In accordance with the main chart, to be determined as non-significant, the change should not:
- Change the purpose of the device,
- Change the design of the device in connection with corrective actions taken by the manufacturer,
- Change the design of the device or its specification,
- Include any changes to the software,
- Impact the materials used to manufacture the device,
- Change the sterilization method utilized by the manufacturer.
In case if the proposed changes meet all above mentioned criteria, it should be deemed as non-significant and thus do not impact the validity of the initial certificate.
Other flowcharts provided by the MDCG describe in detail certain points of attention to be assessed related to each criterion from the list above, namely:
- Changes to the intended purpose of the device as indicated by the manufacturer:
- Limitation of intended purpose,
- Extension or other change,
- Addition of a new user or another target population,
- Any changes to clinical use.
- Changes to the design of the device or its performance specification:
- The necessity of additional data to confirm the compliance with the safety and performance requirements,
- The necessity of additional control measures to mitigate risk associated with the use of the device,
- Any changes to the built-in control mechanism or operating principles.
- Changes to the software:
- Changes to the operating system or its components,
- Modifications related to the architecture or the structure of the database,
- Addition of algorithms replacing the user input,
- Any new features,
- New UI or the way the information is presented,
- Minor changes.
- Changes to the materials used:
- Addition of materials of human or animal origin or other changes to such materials,
- Changes that could impact the quality, safety, and performance of the device,
- Changes to the materials provided by the existing suppliers,
- Change of the supplier of the materials.
- Changes to the sterilization or packaging methods utilized by the manufacturer:
- Changes to the primary sterilization method,
- Changes to the design of the device that impacts the sterilization aspects,
- Substantial changes in packaging,
- Changes to the shelf-life (should be confirmed by the protocols approved by the NB).
Summarizing the information provided hereinabove, the document issued by the MDCG contains detailed guidelines regarding the way the provisions on significant changes set forth by the Medical Device Regulation 2017/745 should be applied with regard to the certificates issued under the MDD/AIMD framework.
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