Technical Documentation
How to ensure user manual readability and usability during testing?
What are effective methods for ensuring that user manuals or Instructions for Use (IFUs) are readable and usable during testing? Are there recommended tools or formulas for...
UDI and EUDAMED Requirements for Legacy MDD Devices as of May 2023
Do legacy MDD devices need a UDI and/or to be registered in EUDAMED since May 2023, or has this requirement been postponed? There seems to be confusion regarding UDI labeling...
FDA requirements for SBOM submission: summary, machine-readable formats, and PDF attachments
Our company recently submitted a 510(k) and received questions from the FDA about our Software Bill of Materials (SBOM). Specifically, the FDA is asking for a "summary" of the...
FDA 'General Use' Classification for Surgical Instruments Intended for Specific Procedures
I am working on a device that appears to fall under FDA product code GDI (Dissector) as defined in 21 CFR 878.4800, "Manual surgical instrument for general use." However, this...
Should IT administrators be included as user roles in MDR technical documentation for SaMD?
During our recent MDR technical documentation review, the notified body requested that we include service personnel (administrators) as user roles in our product description....
How to convert GTIN-13 to GTIN-14 for EUDAMED UDI-DI submission?
EUDAMED appears to expect a GTIN-14 for UDI-DI, but most products have a GTIN-13 as default. Is it valid to add a leading zero to a GTIN-13 to create a GTIN-14 for EUDAMED?...
How to handle incremental software changes during MDR certification?
We are preparing our device for MDR certification but are struggling with the problem of incremental changes: • We submitted our Technical Documentation (TD) for version 2.14 in...
How to comply with EU 207/2012 electronic IFU requirements for medical device apps?
How should manufacturers of standalone software medical devices (apps) distributed via app stores comply with the requirements of EU regulation 207/2012 regarding electronic...
What name should appear on an IEC 60601 conformity certificate for hardware supplied by a third party?
Our medical device consists of both hardware and software. The hardware is supplied by a third-party supplier, who is also organizing the conformity testing to IEC 60601. The...
Experience navigating significant change notifications under MDR/IVDR for SaMD
Are you working in regulatory affairs or quality assurance at a software as a medical device (SaMD) company with a device certified under MDR or IVDR? I am interested in your...
How to handle MDR (EU) 2021/2226 Article 5.3 and 5.4 requirements for eIFU?
I am looking for guidance on how to handle the requirements from Article 5.3 and 5.4 of (EU) 2021/2226 regarding electronic instructions for use (eIFU): • Article 5(3): What...
How to select the appropriate EMDN code for stand-alone medical device software?
I need to register a stand-alone medical device software in EUDAMED and am uncertain which EMDN code to use. V92 - MEDICAL DEVICE SOFTWARE - NOT INCLUDED IN OTHER CLASSES seems...
How to find UMDNS and GMDN codes for SaMD?
What is the best way to find the UMDNS and GMDN codes for a software as a medical device (SaMD)? I've tried searching the freely available lists online using various keywords,...
Difference between Annex IX and Annex XI for MDR Class IIa Technical File Review
Hello, In terms of MDR Class IIa Technical File review (certification), what is the difference between Annex IX and Annex XI?
What are the requirements for 'Authentisierung von GKV-Versicherten' for DiGAs in Germany from January 1st?
I am seeking clarification on the mandatory requirement for 'Authentisierung von GKV-Versicherten' (authentication of statutory health insurance holders) that applies to DiGAs...
Using Own Device as Equivalent Device During MDD to MDR Transition
Is it permitted to use a company's own device as an equivalent device during the transition from MDD to MDR? For example, if a device was Class I under MDD and will transition...
Is CE marking required for internally used EEG analysis software provided as a service to hospitals?
We are a startup providing EEG analysis services to psychiatric hospitals using software developed for our own internal use. We are ISO 13485 certified and initially planned to...
Is it necessary to include device classification and intended use in every section of DHF and TD documentation?
Is it required to always include sections with device classification, device description, intended use, contraindications, and indications at the beginning of every document in...
Can a software feature be labeled as RUO or performance evaluation only within a medical device software?
Is it possible for one feature within a software product to be labeled as Research Use Only (RUO) or for performance evaluation only, while the rest of the software is a medical...
Are commercial VR headsets and computers considered medical device accessories under MDR when sold as a system with SaMD?
At our company, we develop software for cognitive assessments that requires a virtual reality (VR) headset (such as an HP headset) and a computer to operate. The software is...