Note: The following discussion applies to non-custom, non-investigational medical devices.
If you manufacture medical devices for sale in the European Union, you’ll have to show that they conform to the EU’s new Medical Device Regulation (MDR). How you demonstrate conformity depends on how big a risk your device presents to patients. For devices that pose the greatest risk – devices that European regulations designate as class IIa, class IIb, and class III – you have to engage a Notified Body (NB), a third-party organization that assesses your device’s fulfillment of the EU’s requirements on behalf of an EU member state.
But what if the device you want to sell in Europe belongs to class I, the lowest risk class under MDR? If you had experience with the now expired Medical Device Directive (MDD), you may be familiar with the concept of manufacturers “self-certifying” class I devices, without requiring a conformity assessment by an NB.
So what’s the situation under MDR? Does “self-certification” still exist for class I devices in the regulations?
Well, according to MDR, there are class I devices, and then there are class I devices….
If your class I device –
- is not sold sterile,
- does not have a measuring function, and
- is not a reusable surgical instrument,
then MDR does provide a pathway for you to “self-certify” it. (As for what that process entails – that’s a topic for another time.)
But what about the class I devices that are sold sterile, that do have a measuring function, or that are reusable surgical instruments? As we take each in turn, you may pick up on a pattern:
If your class I device is sold sterile, then you do need an NB – though not to perform an entire conformity assessment, but only to review how you establish, secure, and maintain sterile conditions. (Sterile class I devices are known informally, by the way, as “class Is;” see guidance document MDCG 2019-15.)
Similarly, if your class I device has a measuring function, you need an NB – but only to review how you ensure conformity with the device’s metrological requirements. (Class I devices with a measuring function are known informally as “class Im.”)
And if your class I device is a reusable surgical instrument? You need an NB – but only to review aspects relating to the reuse of the device, especially cleaning, disinfection, sterilization, maintenance and functional testing, and the relevant instructions for use. (As you may have guessed by now, class I devices that are reusable surgical instruments are known informally as “class Ir.”)
If all of this is new to you or your company, the Fang Team of consultants can partner with your regulatory team and answer any questions they may have. We have experience with the EU regulations and can help assess any gaps your documentation may have. Contact us today.
