Devices without an intended medical purpose: how to comply with the EU MDR legal requirements?
EU medical device regulation (MDR) 2017/745 Annex XVI products are those with only an aesthetic or another non-medical purpose claim, but which are similar to medical devices in terms of functioning and risk profile. Devices like solid body contour modifying implants, dermal fillers, liposuction devices, hair removal devices, or brain stimulation devices for meditation purposes (among others) fall in this category of "device without an intended medical purpose".
The most important part is to delineate the risk of such devices to the individual, so questions like:
1) Is the product invasive?
2) Is the product implanted?
3) Does the product involve an intervention or technology that may pose a risk to the safety of users and other persons if specific regulatory controls are not applied, such as risks from lasers or radiation exposure?
should be the first thing to ask.
If any of those answers are YES, then the device is not a low-risk device. So, how to comply with the EU MDR legal requirements?
✅ Identify which risk class the device falls into.
✅ Ensure the device complies with the MDR and GSPR, as well as the common
specifications for the specific group-product.
✅ Prepare a Clinical Evaluation Plan (CEP) and Gap Analysis to know if a clinical investigation is needed to show the safety and positive benefit-risk of the device. If no clinical investigation is need, prepare the Clinical Evaluation Report (CER) and technical file.
✅ Assign a basic unique device identifier (UDI) and provide it to the UDI
database. If required, pass a conformity assessment carried out by a Notified
Body, and draw up a declaration of conformity to place a CE mark on the
device.
✅ Submit key information about the manufacturer, person responsible, and authorised representative and importer (if the manufacturer is outside the EU), to the electronic system (EUDAMED).
✅ For implantable Class III devices, such as dermal fillers, provide patients with an implant card, as well as rapid access to important information on the device.
✅ Meet the post-market surveillance (PMS) and vigilance requirements, such as conducting field safety corrective actions and reporting serious incidents to the competent authorities.
✅ For class III devices and implantable devices, the PMCF evaluation report and, if indicated, the summary of safety and clinical performance (SSCP) shall be updated at least annually. The clinical evaluation, its results and the clinical evidence derived from PMCF shall be used to update the CER.
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The most important part is to delineate the risk of such devices to the individual, so questions like:
1) Is the product invasive?
2) Is the product implanted?
3) Does the product involve an intervention or technology that may pose a risk to the safety of users and other persons if specific regulatory controls are not applied, such as risks from lasers or radiation exposure?
should be the first thing to ask.
If any of those answers are YES, then the device is not a low-risk device. So, how to comply with the EU MDR legal requirements?
✅ Identify which risk class the device falls into.
✅ Ensure the device complies with the MDR and GSPR, as well as the common
specifications for the specific group-product.
✅ Prepare a Clinical Evaluation Plan (CEP) and Gap Analysis to know if a clinical investigation is needed to show the safety and positive benefit-risk of the device. If no clinical investigation is need, prepare the Clinical Evaluation Report (CER) and technical file.
✅ Assign a basic unique device identifier (UDI) and provide it to the UDI
database. If required, pass a conformity assessment carried out by a Notified
Body, and draw up a declaration of conformity to place a CE mark on the
device.
✅ Submit key information about the manufacturer, person responsible, and authorised representative and importer (if the manufacturer is outside the EU), to the electronic system (EUDAMED).
✅ For implantable Class III devices, such as dermal fillers, provide patients with an implant card, as well as rapid access to important information on the device.
✅ Meet the post-market surveillance (PMS) and vigilance requirements, such as conducting field safety corrective actions and reporting serious incidents to the competent authorities.
✅ For class III devices and implantable devices, the PMCF evaluation report and, if indicated, the summary of safety and clinical performance (SSCP) shall be updated at least annually. The clinical evaluation, its results and the clinical evidence derived from PMCF shall be used to update the CER.
Need any help?