Why every medical device manufacturer should know their GSPRs
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TL;DR
(too lazy, didn’t read)
Medical devices need to meet specific performance and safety requirements called GSPRs (General Safety and Performance Requirements) before they can be sold in Europe. Essentially it's like a super-detailed safety checklist that ensures medical devices are safe and work like they are supposed to. In this guide, we break down what GSPRs are, outline their three main categories, and cover the key information you need to show your device complies with them.
Introduction
The EU Medical Device Regulations (MDR 2017/745) are incredibly long and are a long, complex read. Believe me I have done it. While every excruciating detail of what requirements you need for medical device compliance are in there, buried in there under Annex I is the GSPRs.
The GSPRs are like the 10 commandments of medical device compliance in the EU (only there are much more than 10). If you satisfy all of the relevant GSPRs, then your product complies with the regulations.
This is why you need to create a GSPR checklist when you are putting together all your documentation to show you comply. In the checklist, you’ll list out each GSPR and identify what evidence you have to supply it.
For this reason, some people like to start with the GSPRs to map out all your requirements. Others like to do the GSPRs at the end if they are sure they have done everything right and just need to log their evidence.
One thing is true, the faster you embrace understanding the regulations and requirements, the sooner you get to market. GSPRs are a great way to know your baseline requirements you will need to meet.
What Are GSPRs Anyway?
As we said, GSPRs are requirements in the regulations but they usually materialize as a checklist used by medical device manufacturers to prove that they are compliant with safety and performance requirements set by the EU. They cover everything from basic safety requirements to specific rules about design, manufacturing, and even what information needs to go on the product label.
Now - an important thing to note here. There are 185 individual requirements spread across the three main categories. That might sound overwhelming, but remember: not all of them will apply to your device!
For example, requirements about implantable devices won't matter if you're not developing something to implant in people. Makes sense right?
The Three GSPR Categories
GSPRs are divided into three main areas:
- General Requirements (23 points covering the basics of safety and performance)
- Design and Manufacturing Requirements (98 detailed specifications)
- Information Requirements (68 requirements about device documentation)
Each category serves a specific purpose. The general requirements ensure basic safety, while design and manufacturing requirements get into the nitty-gritty of how your device should be built. Information requirements make sure users have everything they need to use the device safely.
How to Prove Compliance
As with everything in medical device compliance, you can't just say "trust me, it's good." You need to prove it.
To prove your product meets GSPR requirements, start with a GSPR template that lists all of them out. The European commission put out an official one a while ago you can use. Here is the link.
Always use official templates if they’re available, it makes it a whole lot easier and doesn’t happen often for EU documentation.
In order to fill out the GSPR checklist make sure you do the following:
- Follow specific standards (like ISO guidelines)
- Reference detailed documentation with document numbers
- Justify any GSPRs that don’t apply to your device
Keep everything organized and easily accessible. This is a SUPER long document
Practical Tips and Takeaways
Start Early
- Don't wait until your device is finished to think about GSPRs
- Include safety requirements in your initial design planning
- Keep a running checklist as you develop your product
- Consider GSPRs during your initial brainstorming sessions
Document Everything
- Create a detailed GSPR checklist (use the template above)
- Keep track of all your test results and certifications
- Be specific about where to find supporting documentation
- Use a quality management system to keep everything organized
Stay Updated
- Keep an eye on new standards and requirements
- Update your documentation when regulations change
- Make sure your checklist is a "living document"
- Check to make sure your product doesn’t require any additional Common Specifications
Get Expert Help
- Don't try to navigate this alone
- Consider working with regulatory experts (Like FormlyAI)
- Join industry groups to stay informed
- Build relationships with notified bodies early
Conclusion
Getting a medical device certified is all about proper planning and perseverance. To regulators, it's about proving your device is safe and effective. GSPRs might seem overwhelming and extra, but they're necessary to help ensure products work as intended and don't harm patients.
Plus, GSPRs are a super easy way for auditors to confirm you have done your homework. That checklist will be a critical guide to your successful audit.
One of the best ways to get started is to take it one step at a time. Try creating a simple checklist of requirements that might apply to your product or area of interest. Every process begins somewhere and starting simple is the best way to navigate medical device compliance.
Frequently Asked Questions
GSPRs (General Safety and Performance Requirements) are requirements in the regulations but they usually materialize as a checklist used by medical device manufacturers to prove that they are compliant with safety and performance requirements set by the EU. They cover everything from basic safety requirements to specific rules about design, manufacturing, and even what information needs to go on the product label.
GSPRs (General Safety and Performance Requirements) are requirements in the regulations but they usually materialize as a checklist used by medical device manufacturers to prove that they are compliant with safety and performance requirements set by the EU. They cover everything from basic safety requirements to specific rules about design, manufacturing, and even what information needs to go on the product label.
GSPRs (General Safety and Performance Requirements) are requirements in the regulations but they usually materialize as a checklist used by medical device manufacturers to prove that they are compliant with safety and performance requirements set by the EU. They cover everything from basic safety requirements to specific rules about design, manufacturing, and even what information needs to go on the product label.
GSPRs (General Safety and Performance Requirements) are requirements in the regulations but they usually materialize as a checklist used by medical device manufacturers to prove that they are compliant with safety and performance requirements set by the EU. They cover everything from basic safety requirements to specific rules about design, manufacturing, and even what information needs to go on the product label.
GSPRs (General Safety and Performance Requirements) are requirements in the regulations but they usually materialize as a checklist used by medical device manufacturers to prove that they are compliant with safety and performance requirements set by the EU. They cover everything from basic safety requirements to specific rules about design, manufacturing, and even what information needs to go on the product label.
GSPRs (General Safety and Performance Requirements) are requirements in the regulations but they usually materialize as a checklist used by medical device manufacturers to prove that they are compliant with safety and performance requirements set by the EU. They cover everything from basic safety requirements to specific rules about design, manufacturing, and even what information needs to go on the product label.
GSPRs (General Safety and Performance Requirements) are requirements in the regulations but they usually materialize as a checklist used by medical device manufacturers to prove that they are compliant with safety and performance requirements set by the EU. They cover everything from basic safety requirements to specific rules about design, manufacturing, and even what information needs to go on the product label.
There are 185 individual requirements spread across three main categories:
- General Requirements (23 points covering the basics of safety and performance)
- Design and Manufacturing Requirements (98 detailed specifications)
- Information Requirements (68 requirements about device documentation)
There are 185 individual requirements spread across three main categories:
- General Requirements (23 points covering the basics of safety and performance)
- Design and Manufacturing Requirements (98 detailed specifications)
- Information Requirements (68 requirements about device documentation)
There are 185 individual requirements spread across three main categories:
- General Requirements (23 points covering the basics of safety and performance)
- Design and Manufacturing Requirements (98 detailed specifications)
- Information Requirements (68 requirements about device documentation)
There are 185 individual requirements spread across three main categories:
- General Requirements (23 points covering the basics of safety and performance)
- Design and Manufacturing Requirements (98 detailed specifications)
- Information Requirements (68 requirements about device documentation)
There are 185 individual requirements spread across three main categories:
- General Requirements (23 points covering the basics of safety and performance)
- Design and Manufacturing Requirements (98 detailed specifications)
- Information Requirements (68 requirements about device documentation)
Yes, the European commission has one on their website here.
Yes, the European commission has one on their website here.
Yes, the European commission has one on their website here.
Yes, the European commission has one on their website here.
It comes down to your preference. Some people like to start with the GSPRs to map out all your requirements. Others like to do the GSPRs at the end if they are sure they have done everything right and just need to log their evidence.
It comes down to your preference. Some people like to start with the GSPRs to map out all your requirements. Others like to do the GSPRs at the end if they are sure they have done everything right and just need to log their evidence.
It comes down to your preference. Some people like to start with the GSPRs to map out all your requirements. Others like to do the GSPRs at the end if they are sure they have done everything right and just need to log their evidence.
It comes down to your preference. Some people like to start with the GSPRs to map out all your requirements. Others like to do the GSPRs at the end if they are sure they have done everything right and just need to log their evidence.
It comes down to your preference. Some people like to start with the GSPRs to map out all your requirements. Others like to do the GSPRs at the end if they are sure they have done everything right and just need to log their evidence.
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