Are amendments to the Declaration of Conformity needed for non-significant UI changes shown in screenshots?

If your device is MDR compliant, your Post-Market Surveillance (PMS) activities, including the PSUR, need to follow MDR requirements. According to MDR Article 83(3)(c), PMS should update your Clinical Evaluation, and MDR Annex III states that PMS activities should include up-to-date literature and event database reviews. Even though your CER says it can be updated every two years, for MDR devices you should update your literature search and incident research at least annually to align with the PSUR. This helps reduce the chance of issues with your Notified Body during audits. For MDD transitional devices, the rules are a bit more flexible, but for MDR you should definitely sync updates with the annual PSUR.

If you do not conduct clinical investigations, you may not need a full clinical development plan as described in MDR Annex XIV. Instead, provide a clear rationale in your Clinical Evaluation Plan explaining why a development plan is not necessary for your device. For software or devices based only on guidelines and verification/usability testing, evidence of scientific validity and performance can be sufficient. Just make sure to document your reasoning and, if applicable, describe how post-market clinical follow-up or other data will be collected in the future.

Linguistic validation is required when language could impact the device's safety or performance, especially if the device will be used in countries with different official languages than where clinical trials were conducted. MDR Article 10(11) states that information, including labelling and software interfaces, must be available in the official language(s) of each member state and be clearly comprehensible to the intended user. The level of validation depends on user risk and device type, but certified translation and usability checks with native speakers (preferably with medical backgrounds) are good practice. Some countries also expect a quality certificate from a translation agency, and additional user validation may be requested by notified bodies.

For DiGA submissions, it's common to use an external contractor or service supplier, such as a hospital, CRO, or research institute, to sign the Evaluation Concept. This is acceptable as long as the institution is independent from the manufacturer. The institution generally signs off on the evaluation plan, but responsibility for the data analysis and study conduct depends on your contract. Some CROs or hospitals only provide sign-off, while others may take on data analysis. BfArM's requirements are not highly specific, so using an experienced and reputable institution, ideally with prior DiGA experience, is recommended. A systematic data analysis can also be done internally if needed.

You can obtain ISO 13485 certification from one certification body and MDR certification from another notified body, but it's often simpler to have both from the same notified body. Notified bodies will still need to review your QMS and technical documentation for MDR conformity, even if you already have ISO 13485 certification. For acceptance of foreign certifications, ISO 13485 certificates from outside the EU are technically accepted if the certification body is properly accredited, but for Germany (and many EU countries) it's safest to choose a certification body accredited by local authorities (like Dakks for Germany). The list of EU-notified bodies is available on the NANDO website.

If the UI change is purely cosmetic and does not affect medical data presentation or device safety, and the change appears in a screenshot on the DoC, you typically do not need to amend the DoC. Instead, you can document the change internally and, if needed, add an annex explaining the change and why it is non-significant. The key is to justify why the change is non-significant and ensure this is recorded for audits. The DoC is considered a snapshot, so not every minor UI update requires an official amendment.