The General Safety and Performance Requirements (GSPR) specify mandatory safety and performance requirements which must be met before placing a device on the market in the European Union. The GSPR can be found in Annex I of EU MDR. MedTech companies must demonstrate and declare their conformity with these requirements (via EU Declaration of Conformity) before placing their devices on the market in the EU.
The best way to demonstrate conformity is by using a GSPR checklist. Even though there is no specific regulatory requirement to establish a GSPR checklist, this simple tool is widely recognized as the best way to show conformity with the GSPR. In fact, notified bodies expect to see this checklist in submissions from medical device companies.
With that in mind, we’re going to cover how to conform with the GSPR, as well as how to build your own GSPR checklist that demonstrates your compliance.
There are 23 General Safety and Performance Requirements listed in Annex I of EU MDR. While the Annex is too lengthy to reproduce here, the requirements are broken up into three sections:
Medical device companies must be able to demonstrate compliance with all GSPRs that are applicable to their device. In some cases, a GSPR may not be applicable to your device. However, you will need a strong justification as to why any requirement is not applicable.
It’s also important to begin the gap analysis between your device and the GSPR requirements as early as possible in the design phase. The GSPR represent a set of requirements to which medical devices must conform, so it makes little sense to wait until the end of design and development to take the GSPR into account.
While some of the GSPR go into detail regarding how to fulfill the requirement, many of them are high-level requirements without a roadmap for conformity.
That’s why the best way to ensure your conformity with the GSPR is by using harmonized standards. Harmonized standards have been through a review process, and sometimes have supplemental annexes that ensure conformity with the standard will result in conformity with the relevant GSPR. The standards are also more granular than the GSPR, providing a clearer roadmap of how to conform with them.
For instance, Annex I, Chapter I, Clause 3 of MDR states, “Manufacturers shall establish, implement, document, and maintain a risk management system.” In order to fulfill this GSPR, you should apply ISO 14971:2019, the international standard for the application of risk management to medical devices. However, you will want to use the specific, harmonized version of the standard, which is EN ISO 14971:2019/A11:2021.
NOTE: While using harmonized standards is ideal, the process for harmonizing these standards with EU MDR is lengthy, and it’s unlikely that every standard you need will be harmonized. In this case, it’s fine to use the non-harmonized version of an international or national standard to help you meet the GSPR.
The European Commission has a full list of harmonized standards, but here are a few of the most commonly used standards:
|
Standard Name |
Use |
|
EN ISO 14971:2019/A11:2021 |
Application of risk management to medical devices |
|
EN ISO 13485:2016/A11:2021 |
Quality management systems - Requirements for regulatory purposes |
|
EN ISO 15223-1:2021 |
Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements |
|
EN ISO 17664-1:2021 |
Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices |
Aside from harmonized standards, there are other documents you can use to establish compliance in some cases. Common Specifications (CS) are requirements the European Commission has adopted when standards are not considered sufficient. Though there are only a few CS currently available, they are mandatory and there may be more created in the future. The currently available CS cover:
So, if we look at all the resources available to help you meet the GSPR, the hierarchy for applying them looks like this:
If you’re using harmonized standards and common specifications, then you should have all the information you need to build out a GSPR checklist. The basic components of the checklist should include:
Each GSPR written out in full;
Whether the GSPR is applicable to your device (with justification if it is not applicable);
The standard, common specification, or procedure you are using to achieve conformity;
The methods used to demonstrate conformity (e.g., risk-benefit analysis, hazard analysis/system risk assessment, user training, usability studies);
Where these records can be located in your technical documentation.
Now, building a checklist like this is fairly time-consuming, even with all your documentation in order. That’s why we’ve created a free, downloadable GSPR checklist template for you to use. It has everything you need to quickly begin building your checklist and identify any gaps or areas for improvement.
When a regulation is as long as EU MDR, it can feel like compliance is an impossible task. But with the right help, you can ensure compliance with regulatory requirements and demonstrate it to your notified body when the time comes. All you need are the right tools.
That’s why at Greenlight Guru, our QMS software is tailored to help you comply with the requirements of ISO 13485:2016, ISO 14971:2019, and EU MDR. When you choose Greenlight Guru Quality, you can be sure that you’re getting a QMS solution built specifically to help medical device companies achieve compliance and build the safest, most effective devices possible.
If you’re interested in learning more about how Greenlight Guru helps make compliance easy, then get your free demo of our software today.