Dr. Akra answers FAQs on the Medical Device Regulation (MDR)
I am frequently being asked about the Medical Device Regulation (MDR) by customers or fellow attendees of talks and presentations. Uncertainty is still rife. I would, therefore, like to provide answers to some of these questions here:
“Will the notified body number change when moving to the MDR?“
Some notified bodies are introducing the rumors that the notified body number will change with the new MDR. This is incorrect and not written neither in the regulation nor in any further FAQ of the EU Commission. It is just applicable for notified bodies which are changing their location, such as the one impacted by the Brexit. Check the EU Commission Website to get more details on that topic.
“Will the number of notified bodies change?“
Several questions have arisen publicly regarding the number of notified bodies which have applied for the new MDR and IVDR regulations. These kinds of information are not typically published and made transparent on a single EU system, therefore, get in contact with your notified body, and request information on the status of their application process. I have been informed that a large number of applications were sent, but not all notified bodies applied. It seems also that authorities were positively surprised by newcomers in this field.
“How can we prepare best for MDR and IVDR?”
I keep getting the question on how to prepare best for the upcoming EU regulation(s) (MDR and IVDR). Read the regulation(s) first and do not wait until somebody else will explain them to you. You will just identify the impact by reading and doing your specific impact assessment on your product portfolio. Start today and be ready for the future which cannot be changed anymore. Do not expect further extension of the timelines, but prepare yourself as soon as possible. I found the following wording of Stephen Hawking which confirms my suggestion: “Nothing is better than reading and gaining more and more knowledge.” (Stephen Hawking)
“What is “clinical performance”, “clinical evaluation” and what does “clinical benefit” mean?”
Per regulation 2017/745, demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation in accordance with Article 61.
Clinical evaluation means a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device, in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.
Clinical performance means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer.
Clinical benefit means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome, including outcome related to diagnosis, or a positive impact on patient management or public health.
More FAQs can be read on our TÜV SÜD webpage.