There are few product types that deserve special attention today, considering BUDI requirements, and I would like to talk about software as a medical device. As indicated here, the only software that is subject to UDI requirements are those that are commercially available on their own, or they constitute a standalone device.
If the software is an integral component of your device, such instances would be free from the UDI requirements. As indicated here, a new UDI is required in instances when you have a modification that changes the original performance, the software, or the interpretation of the data. It can also be required when you have either, any change that could result in misidentification of your device, or an ambiguity in its traceability.
Graphically, it is shown here, showing what could trigger a new UDI, which includes changes in your BUDI-DI, changes that impact performance and safety, or your interpretation of the data. Also, this includes changes to your trade name or other proper names, your version or model number, warnings or contraindications, and changes to the interface language.
Minor software changes, like bug fixes, would not rise to the level of requiring a new BUDI assignment, even though they would require a new product identifier of the UDI type (UDI-PI). However, if such a change rises to the level that it requires a security patch, or an enhancement to the operating efficiency of the software, it would be reverted to the UDI, triggering a major change, which would also be necessary to submit in a significant change note.
Many of you will be interested in marketing in the UK post-Brexit, and as we get closer to the end of 2020, it looks more likely that we may be dealing with a hard Brexit at the end of the year. As we discussed previously the MHRA has been providing guidance on this subject.
One of the things that will be introduced, is a new Conformity Assessment Mark, called the UKCA Mark. This will be a homolog, if you will, of the EU CE Mark for conforming devices. This will be necessary for those of you interested in marketing in the UK for all devices, after the midpoint of 2023, which is June 30th.
To obtain and to apply such a CE Mark, you are required to have a UK approved notified body, and an audit, in order to get the certificate and to fix the UKCA Mark on your labeling and device.
The MHRA has provided an allowance for those of you that may need a bit of time to comply with this requirement. Specifically, they are allowing manufacturers with current EU certificates that are either issued under the directive or the regulation – that is MDD and IVD, AIMDD, MDR or IVDR certificates – to remain valid in the UK, up to the mid-year point of 2023. So, we will have some time to comply with this regulation before it takes effect.
However, for new products that are going to be introduced to the UK after the end of 2020, these will now require separate audits and conformity assessments, except for products that are in class I self-declared groups.