Questions
Practical answers to recurring medical device compliance questions from founders, RA/QA teams and operators in the field.
Trend reporting is a PMS input or output?
Annex III of MDR: • The PMS plan shall address the collection and utilization of available information, in particular: information from trend reporting; • The post-market...
Is internally used diagnostic software considered a medical device under MDR?
Our company has developed three software components related to EEG and ECG biomarkers to support psychiatric treatment decisions: • A web interface for hospitals and clinics to...
Is a US-based test dataset mandatory for FDA clearance of dental AI software?
At our company, we are developing dental AI software and are preparing for FDA clearance in the US. We understand that having data from US sources is beneficial, but is it...
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...
Does software that analyzes EHR blood test results meet FDA CDS criterion 1?
Our company has a device that analyzes blood test results, biological sex, and age, with all input information coming from the electronic health record (EHR). According to the...
Are there FDA requirements for non-device clinical decision support software?
According to the new FDA guidance on clinical decision support software, our software is classified as a non-device. What are the requirements for bringing such software to the...
Is it appropriate to exclude ISO 13485 section 7.6 for SaMD under IVDR?
Our product is a Software as a Medical Device (SaMD) that falls under the IVDR. It uses blood and genetic data as input to calculate disease risks for patients via machine...
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...
Examples for SOP content for Infrastructure and Work Environment in ISO 13485 QMS for software
Our company is establishing a QMS according to ISO 13485, and I have been asked to identify procedures, assign them to the standard's clauses, and draft SOPs. My background is...
Is the FDA planning to drop Part 11 requirements for electronic records?
There was a discussion about whether the FDA is considering dropping Part 11 requirements for electronic records. The question was raised because the FDA's proposal mentions...
Why can some US-marketed health software claim disease risk without FDA medical device approval?
I have seen a company marketing its software product in the US, making statements about disease risks (for example, providing cardiovascular or cancer risk scores) directly to...
Are there equivalent classifications to FDA Class I and II viewers under EU MDR?
According to the FDA, there are two classifications for medical image viewers: Class I for non-diagnostic viewers (intended only for review) and Class II for diagnostic viewers....
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...
How to refine and standardise data quality control requirements for medical device algorithms?
Data quality control is important for medical device product quality, especially for data-based algorithms. What efforts are made to standardise data quality control...
How should change control be applied to complementary software in medical device projects?
How should change control be implemented for software that complements a medical device? Should the change evaluation apply only to the medical device software, or should it...
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 prepare for MDR QMS audits by Notified Bodies?
What are some effective strategies to prepare for MDR (Medical Device Regulation) QMS (Quality Management System) audits conducted by Notified Bodies? Are there specific...
How can the usability of the MDR and related standards be improved for startups?
One user described difficulties in applying the Medical Device Regulation (MDR) and related standards, especially as a startup. The user finds the regulations and standards...
Is EUDAMED registration mandatory for economic operators in Germany?
I understand from MDCG 2022-12 and Article 28 that EUDAMED registration is voluntary unless a member state requires otherwise. In Germany, it appears that registration in...
Does software that provides glasses prescriptions perform a diagnosis under EU MDR?
Our company has developed a device for eye exams that calculates refractive measurements (myopia, hyperopia, astigmatism) and provides values (+ or -) for glasses or contacts....
How to ensure GDPR compliance for patient data logging in a digital health clinical trial?
We are preparing to launch our first clinical trial for a digital health app for diabetes. Our process is as follows: collect patient data via the app, store it locally, export...
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?...
Do distributors need to register in EUDAMED under MDR?
I am seeking clarification regarding the registration requirements for economic operators in EUDAMED under the Medical Device Regulation (MDR). Specifically, do distributors (as...
Why are some devices and UDIs not listed on EUDAMED despite manufacturer registration?
I noticed that although a manufacturer is listed in EUDAMED, they do not have any devices appearing under their profile. Specifically, I could not find devices for this...
Is a new QMS audit required for MDR certification if we already have MDD and ISO 13485 certification?
Our company has a device certified under the MDD with a certified QMS (quality management system). We are planning to transition to MDR certification. Do we need to undergo a...
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...
Recommendations for EU-compliant electronic signature systems for medical device documentation
Our company is seeking recommendations for electronic signature systems that comply with EU requirements (no FDA considerations for now). We currently use a validated internal...
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...
Is EEG data considered a "specimen" under the IVDR?
Is it possible to consider data as a "specimen" under the IVDR? Specifically, our company analyzes EEG data samples in a similar fashion to how DNA analysis companies handle...
Is ISO 13485 certification required before CE marking for software medical devices in the EU and Switzerland?
We want to certify our software as a medical device in the EU and Switzerland. I have two questions: • Is it necessary to first obtain ISO 13485 certification before applying...
Are distributors required to register in EUDAMED under MDR?
We are reviewing the requirements for economic operators and their registration in EUDAMED. Specifically, do distributors (as defined in MDR Article 14) have to register in...
Is the EU planning to clarify regulation of continuously learning AI in medical devices?
I am looking for literature or official documentation indicating that the EU is planning to provide more clarity regarding the regulation of continuously learning or dynamic AI...
Recommendations for EU Notified Bodies for CE and MDR applications outside Germany
Our company is developing a medical device software and is seeking recommendations for Notified Bodies in the EU, outside of Germany, where we can apply for CE marking and MDR...
How to generate EUDAMED ID DI for MDD devices and what manufacturer device code is needed?
When registering MDD devices in EUDAMED using the EUDAMED ID DI, is a manufacturer device code required, and where can it be obtained? Does EUDAMED generate the EUDAMED ID and...
Can clinical evaluation for a Class I SaMD app rely on literature from similar, but not equivalent, devices?
I am working on the clinical evaluation for a mobile application (Class I, SaMD) that helps people quit smoking. The app features interactive therapy articles with quizzes, a...
Are EU MDR obligations triggered if an EU manufacturer sells via a distributor outside the EU?
Does the EU MDR place any obligations on an EU-based manufacturer if a product is sold outside the EU through a distributor? For example, if our company manufactures a device in...
Can translated instructional video text be adjusted for lip sync without affecting evidence transferability?
We are preparing to launch our medical device app in a new country and are working with a certified translation agency to translate instructional videos. Our aim is for evidence...
How should code editors like VS Code be validated in SaMD development?
For companies developing Software as a Medical Device (SaMD), is it necessary to validate code editors such as Visual Studio Code as part of the QMS software tool validation?...
How to register MDD devices in EUDAMED and generate EUDAMED ID/DI
Has anyone registered MDD devices in EUDAMED using the EUDAMED ID DI? I have an SRN, but I am unsure if I need a Manufacturer device code to generate the EUDAMED ID and DI, or...
How do you handle CAPA investigations and bug triage for SaMDs?
I am interested in how companies handle CAPA (Corrective and Preventive Action) investigations, especially for Software as a Medical Device (SaMD). In our startup, root causes...
Do IVDR Annex IX Chapter II certificates apply to Class C devices?
Our company received an EU Quality Management System Certificate (IVDR) for Annex IX Chapters I and III. We have a Class C device (not for self-testing, near patient testing, or...
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...
Is CE marking required for internally used medical software provided as a service?
Our company provides EEG analysis services to psychiatric hospitals. We have developed proprietary software to support this analysis, but the software is only used internally by...
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,...
Does providing refractive values for glasses count as a diagnosis under MDR?
Our device is an eye exam tool that calculates refractive measurements, such as + or - values for glasses or contacts, which are then used by an optometrist to issue a...
How do companies handle MDR Annex III complaint investigation and market experience analysis?
According to MDR 2017/745, Annex III, paragraph 1(b), manufacturers must implement effective and appropriate methods and tools to investigate complaints and analyze...
How do you assess and qualify SOUP suppliers, and how do you determine their criticality?
Do you assess and qualify suppliers of SOUP (Software of Unknown Provenance)? For example, some SOUP items like cloud infrastructure can directly impact product safety and...
Is it sufficient to use literature data only for MDR clinical evaluation of SaMD, or is own clinical data required?
We are a software medical device manufacturer currently under risk class I MDD, but will be in risk class IIa under MDR. For the upcoming MDR certification, is it necessary to...
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?
Do DiGA changes need to be reported to BfArM prior to implementation?
Are manufacturers of DiGAs (Digital Health Applications) required to report changes to BfArM before implementing them? How do these requirements compare to those in MDCG 2020-3?...
Is UDI required for Class I devices under MDR before May 2025?
Is it necessary to have a UDI (Unique Device Identification) for Class I medical devices under the EU MDR before May 2025? I have seen conflicting information, with some sources...
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 it permissible to provide access to a DiGA app before insurance approval?
We are developing a DiGA app and would like to allow users to start using the app before their insurance company has approved their access (i.e., before they receive the code...
Is additional registration required in France for MDR Class I device already registered in Germany?
Our company is a non-EU manufacturer with an assigned EU Authorized Representative. Our MDR Class I medical device is already registered with the competent authority in Germany....
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...