Patients will live even safer lives in the future. Thanks to the EU’s Medical Device Regulation, which tightens the thumbscrews. All in the interest of patient safety.
What is new is that the requirements of the MDR will also cover other product manufacturers and users in the future. Let’s take a look at the requirements for so-called PRODUCTS WITHOUT MEDICAL PURPOSE, which are not to be neglected. Because there are surprises.
Already Article 1 paragraph (2) of MDR 2017/745 clarifies the validity of the requirements for products without medical purpose:
“… from the date of application of the common specifications referred to in Article 9 for the groups of devices without a medical purpose listed in Annex XVI”.
And these products currently include:
Contact lenses or other articles intended for insertion into or onto the eye.
Devices intended to be fully or partially introduced into the human body by surgically invasive procedures for the purpose of modifying anatomy or fixing body parts, with the exception of tattooing and piercing products
Substances, combinations of substances, or articles intended for use as facial or other dermal or mucosal fillers by subcutaneous, submucosal, or intracutaneous injection or other means of introduction, except those for tattooing
Devices intended for the reduction, removal or decomposition of fatty tissue, such as devices for liposuction, lipolysis or lipoplasty
Devices intended for application to the human body that emit high-intensity electromagnetic radiation (infrared radiation, visible light, ultraviolet radiation), including coherent and non-coherent light sources and monochromatic and broad-spectrum light, such as lasers and intense pulsed light devices for skin resurfacing, tattoo or hair removal, or other forms of skin treatment
Devices for transcranial stimulation of the brain using electric current or magnetic or electromagnetic fields to alter neuronal activity in the brain
Breathing a sigh of relief because your product is not listed?
Beware, according to the delegated acts under Article 115, more products can be added. Even if your product is not currently covered by the MDR, that can change at any time.
However, it will not happen quite so quickly. The EU must first issue a “Common Specification” (Common specification) for the products concerned in accordance with Article 9.
In the case of the previously mentioned products, the respective common specifications will become valid between May 26, 2020 and November 26, 2020, depending on their enactment date.
The worst-case scenario could mean that only six months remain to comply with the requirements before the “Common specification” comes into force.
Affected manufacturers and distributors should use the time
However, it is already known what will definitely be part of the “Common Specification” and what can serve as a basis so that affected companies can prepare for it. The state of the art must be taken into account:
Harmonized standards already in force for analogous products with a medical purpose that are based on similar technology are to be applied
Risk management according to Annex I is to be carried out
Clinical evaluation of safety according to Article 61, paragraph 9 or Annex XIV, Clinical evaluation and post-marketing clinical follow-up and XV Clinical investigations
Consider and plan aspects for clinical evaluation at an early stage.
Article 61, paragraph 9 states that clinical evaluation shall be based on relevant data on safety, from post-marketing surveillance and clinical follow-up – including, where appropriate, in the context of clinical trials. Further, the paragraph states “For these devices, clinical investigations may be waived only if there are sufficient reasons to rely on existing clinical data on an analogous medical device.” In particular, this reliance on data on analog medical devices is likely to pose new challenges for some manufacturers here.
Don’t forget the EUDAMED database!
A notification of the product in the EUDAMED database as well as the creation and maintenance of product labeling including a UDI (Unique Device Identification) is required.
The essential safety and performance requirements from Annex I
The “essential safety and performance requirements” described in Annex I must be demonstrated, whereby the general safety requirements described in sections 1 and 8 must be understood to mean that the product, when used in accordance with its intended conditions and purpose and maintaining a high level of protection for the health and safety of persons, must not present a risk or a risk greater than the maximum acceptable risk.
Here is the short version: the risk-benefit assessment must also be positive for products without a medical purpose.
The amendment may also affect operators and users
According to the current reading, the amendment means that providers of corresponding cosmetic and aesthetic procedures and applications will fall under the Medical Device Operator Ordinance (MPBetreibV) or its successor – with all their rights, but also obligations.
And BfARM is also likely to be responsible for the affected players in the event of reportable incidents involving the products without a medical purpose.
Are you affected?
Are you affected by this innovation or not yet sure what impact this new legislation will have on you and your company? Or you are already one step ahead and facing the task of a clinical evaluation or even a trial?
Continue reading on seleon’s Clinical Regulatory Affairs page.
Please note that all information and listings do not claim to be complete, are without guarantee and are for information purposes only.