GSPR vs. GPSR may look like a cute wordplay, but there’s more to it than that.
It’s a 10/10 example of the regulatory complexity which medical device companies need to be mindful of.
What I mean is that companies need to watch out for both medical device specific regulation and other legislation that may be applicable to medical devices too.
Because if they don’t, they may get into trouble. And that will cost extra time and money for the companies.
So let’s jump right in to learn more about the GSPR and GPSR.
GSPR
1. What does the GSPR stand for?
The GSPR is an abbreviation for General Safety and Performance Requirement.
2. What is the applicable regulation for the GSPR?
The GSPR can be found in the medical device regulation (MDR) 2017/745. The exact location is MDR Annex I.
And because there are several GSPRs in the MDR, let’s use the plural form GSPRs.
3. Why should medical device companies pay attention to the GSPRs?
The GSPRs are the backbone of the MDR.
In other words, if a medical device manufacturer wants to meet the requirements of the MDR and be able to attach a CE mark to their medical device, they must meet the GSPRs that apply to their device.
4. Should also medical device distributors and importers consider the GSPRs?
Yes, they both should.
MDR Article 13, which defines the general obligations of importers, describes that importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in [the MDR] Annex I and shall comply with the conditions set by the manufacturer, where available.
As for distributors, the GSPR obligation is described more indirectly in the MDR. Nevertheless, distributors, like importers, are expected to verify the manufacturer meets many of the requirements defined in the GSPRs, before placing a device on the market (importers) or making a device available on the market (distributors).
5. When should medical device manufacturers give attention to the GSPRs?
As early as possible.
The reason is that the GSPRs set requirements for key areas of any medical device:
Risk management, design, manufacturing, labels and instructions of use.
The MDR also expects that the manufacturer uses the GSPRs as a thread that runs through the technical documentation and the quality management system.
If the manufacturer starts to think about the GSPRs at the end of device development, it usually results in a lot of going back and forth between documents and sometimes even re-consideration of strategic decisions late in the project (as described in my other blog post).
GPSR
6. What does the GPSR stand for?
The GPSR is an abbreviation for the General Product Safety Regulation 2023/988.
7. What is the applicable regulation for the GPSR?
The GPSR itself is the regulation.
8. Why should medical device companies pay attention to the GPSR?
First of all, medical devices are not on the list of products exempt from the GPSR.
Second, if a medical device is intended for consumers, it is in the scope of the GPSR. The GPSR concerns all consumer products placed or made available on the Union market.
Moreover, the GPSR applies to medical devices when the GPSR provides more specific product legislation than the MDR does regarding product safety requirements.
9. Should also medical device distributors and importers consider the GPSR?
Yes, their obligations are stated in the GPSR Articles 11 and 12. However, as these obligations are described in the MDR too, the MDR takes priority in this case.
Nonetheless, the GPSR ranks higher than the MDR in Article 19. It discusses the obligations of economic operators in the case of distance sales. This is relevant for distributors and importers to consider. I also recommend looking up ‘online interface’ and ‘online marketplace’ in the GPSR. These terms are not defined in the MDR.
What is more, Article 35 provides information from economic operators and providers of online marketplaces to consumers on product safety. It’s worth checking out too.
10. When should medical device manufacturers give attention to the GPSR?
As with the GSPR, I recommend as early as possible. In any case, well before starting to sell medical devices to consumers in any sales channel.
Because the GPSR provides additional legislation for medical device manufacturers, they need time to understand what is required of them and how to implement the needed actions. The earlier they start this process, the better prepared they are to provide safe products to consumers.
Do you have any questions about the GSPR or GPSR?
Just send me a message!
I’m always happy to listen to what’s on your mind and help you take the next step.
