Getting Started
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...
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....
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...
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...
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...
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...
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...
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...
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...
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....
Under what circumstances can a medical app be classified as Class I under MDR?
Is it possible for a medical app to be classified as Class I under MDR, and what are the criteria? For example, if an app offers therapy guidance without personalizing treatment...
Timeline and Minimum Cost for CE Certification Class IIa Without Clinical Trial
How long does it typically take to obtain CE certification for a Class IIa medical device without the need for a clinical trial ("klinische Prüfung")? What is the minimum cost...
Is AI used for image analysis in a medical device always classified as high-risk under the EU AI Act?
I am evaluating the impact of the EU AI Act on a medical device that automates allergy skin prick tests. The process involves pricking a patient's arm with allergens, taking an...
How is medical device regulation developed and how can its usability be improved for start-ups?
I am interested in understanding how medical device regulation, specifically the MDR, is developed and what could be done to improve its usability, especially for small...
What happens after the Substantive Review and AI response in the traditional 510(k) process?
After the Substantive Review in the traditional 510(k) process, and after receiving and responding to the Additional Information (AI) request within the 180-day deadline, is the...
Are there general authentication requirements for patient mobile applications under MDR?
Are there any general guidelines or requirements under the Medical Device Regulation (MDR) for authentication in patient-facing mobile applications? I am specifically interested...
Should we send all our developers to multi-day 8-hour "training sessions" for e.g. the ISO 13485?
Our CEO thinks that "quality is really important" and that "we need to show our investors and customers how much we value quality and safety", and has therefore sent everyone in...
When Should We Start Documenting Our Medical Device And QMS?
We are currently developing our software medical device and might be done in 6 months or so. We want to get started with documenting it right now! What can we do?
Which Notified Body Should We Choose?
Which Notified Body should we choose?
Can We Document Our Software After We've Developed It?
We want to certify our software as a medical device, but we've already developed parts of it (or all of it). Do we have to re-do our entire development, creating "compliant"...
Should We Use Short Or Lengthy Templates For Medical Device Compliance?
We're a startup and currently looking for document templates for our medical device compliance. The OpenRegulatory templates seem to be rather "minimalistic" as they appear...
How Much Does Medical Device Compliance Cost?
We're a startup and are considering bringing a medical device to market. How much does it cost?
How Long Does Medical Device Compliance Take?
We're a startup and want to bring a medical device to market. How long does it take to get all the medical device compliance done, e.g. for a software device?
How To Do Medical Device Software Development?
Our company wants to get into medical device software development. How do we get started and how do we have to change our existing software development processes?
Should We Register Our Algorithm As a Patent?
We’re developing software. Should we patent our algorithm?
How To Find Out Whether Your Regulatory Consultant Sucks
We’re working with a regulatory consultant but are not sure how capable they are. How to we find out whether our consultant sucks? And how do we identify good consultants?
How Do We Certify API-Only Software As a Medical Device?
Our software only provides an API. We think it’s a medical device. How do we get it certified?
Should We Choose Our Cloud Provider Based on Free Credits?
Our startup is part of an incubator and we’ve been approached by a cloud provider which offered us a few thousand Euros in free credits if we go with their platform. Should we...
Can We Bring a Lifestyle Device to Market First?
We’re developing software as a medical device which might be class I or IIa under the MDR. Right now, we don’t want to go through all the regulatory pain and are wondering...
Do We Need AI / Machine Learning Consultants?
We want to develop a medical device which is based on an AI model. We’ve recently been approached by consultants who specialize in the field of medical devices and AI / Machine...
Should You Do a BfArM Classification Request? The Answer Is No.
We have no clue how to classify our medical device under the MDR. It could be class I, so we won’t have a notified body. Is there anyone who could give us a final decision? Our...
As a MDR Class I Manufacturer, Should We Move to Hamburg or Munich?
We want to bring MDR class I software as a medical device to market. We’ve talked to other founders and checked out the list of MDR class I devices on this website and it seems...
Should We Develop Our Software Or Set Up Our QMS First?
We’ve just started developing software which will be a medical device. Some consultants now told us that it’s important to set up our Quality Management System (QMS) first...
MDR Class 1 Devices: Do They Exist (as software)?
I’ve heard that, under the MDR, software is usually classified as class IIa device or even higher. In the past, under the MDD, many software devices were classified only as...
What's the Definition of a Medical Device According to the MDR?
What’s the definition of a medical device according to the MDR?
Is Our Software a Medical Device (and Do We Need to Certify It)?
We’re a startup which is currently developing healthcare software. We’re wondering whether this software would be a medical device. That’s important because then we would need...
Do We Have to Read Those Boring Standards?
We’re in the early stages of founding our company and developing our product. We’re wondering what it takes to certify our software as a medical device. We’ve heard about all...