The Medical Device Authority (MDA) has released the updated 4th Edition of MDA/GD/0020 Change Notification For Registered Medical Device. The latest is a guidance for the medical device industry that guides the categorisation of changes that need to be considered by the stakeholders during the process of change or modification of the device. The industry must ensure that the requirements are met in order to keep the device on the market. The MDA/GD/0020 applies to all registered medical devices.
There are a few highlighted changes made in this revision with the addition of:
- 1. Terms and definition:
a. Editorial changes
- Editorial changes are simple clarifications that do not change the information's substantive meaning. Punctuation changes, grammar corrections, typographical corrections, reordering existing material, rephrasing sentences that do not change the content, and adding headers for ease of use are examples of editorial changes and are exempted from the submission of change notification to MDA.
b. Multiple applications
- Combination of two or more Submission Identification (ID) of medical device per application of change notification
c. Single application
- One Submission Identification (ID) of medical device per application of change notification.
- 2. The categories of change notifications remain the same, which are divided into three: Category 1, Category 2 and Category 3. Category 2 requires MDA evaluation and endorsement, while Category 3 may be implemented immediately.
- 3. Addition of Clause 5.8 for the changes due to EU’s regulatory framework transition to Medical Device Regulation (MDR) and IVD Regulation (IVDR).
- 4. For changes that involve a change of the software version number that does not affect the safety and or performance of the device, may be submitted in batched of 6 monthly submissions from point of first implementation.
- 5. Some of the changes to the labelling do not require a notification to MDA:
i. Changes that are considered as editorial.
ii. Rephrasing information and change the arrangement in the IFU
iii. Labelling that involves the addition and/or removal of language not required by the Authority
iv. Changes in labelling that involve the distributor's updated details, including EU authorized representative, as well as which has no bearing on the medical information on device registration
v. The withdrawal in regulatory status due to a commercial decision, which does not require change notification
- 6. Updated Turn-Around-Time for all single submission (single and combination) and multiple submission to 30 and 60 working days, respectively.
More information and details can be found in the Fourth Edition Guidance Document “Change Notification For Registered Medical Device” (MDA/GD/0020).