Patients will live even safer in the future. Owing to the EU Medical Devices Regulation, which tightens the strings. All in the interest of patient safety.
What is new is that the requirements of the MDR will also affect further product manufacturers and users in the future. Let us shed a light on the requirements for the so-called "PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE" that should not be neglected. Because there are surprises to be found.
Article 1 paragraph 2 of MDR 2017/745 already clarifies the validity of the requirements for the products without an intended medical purpose:
"… as from the date of application of common specifications adopted pursuant to Article 9, to the groups of products without an intended medical purpose that are listed in Annex XVI"
And these products currently include:
- Contact lenses or other items intended to be introduced into or onto the eye.
- Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.
- Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.
- Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
- High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for removing the upper skin layers ("skin resurfacing"), tattoo or hair removal or other skin treatment.
- Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.
Are you breathing relief, because your product is not listed?
Be careful, further products may be added in accordance with the delegating acts referred to in Article 115. Even if your product does not yet fall under the MDR's validity, this may change at any time.
But it will not happen that fast. The EU must first issue a so-called "Common specification" in accordance with Article 9 for the products concerned.
In the case of the above mentioned products, the respective common specifications will apply depending on the date of their adoption - between 26 May 2020 and 26 November 2020.
The worst case scenario could mean that only 6 months remain to meet the requirements before the Common Specifications enter into force.
Manufacturers and suppliers concerned should make use of this time
However, it is already known what will definitely be part of the "Common Specification" and what can serve as a basis so that the affected companies can prepare for it. The state of the art shall be taken into account:
- already existing harmonized standards for analogue products with medical application based on similar technology shall be applied
- Risk management in accordance with Annex I shall be carried out
- clinical evaluation of the safety issues in accordance with Article 61(9) or Annex XIV Clinical evaluation and Post-Market Clinical follow-up and XV Clinical investigation
Consider and plan the aspects of clinical evaluation at an early stage
Article 61(9) states that clinical evaluation shall be carried out on the basis of relevant safety, post-marketing surveillance and clinical follow-up data, including, where appropriate, clinical investigations. The paragraph also states that: "Clinical investigations shall be performed for those products unless reliance on existing clinical data from an analogous medical device is duly justified". This dependence on data on analog medical devices in particular is likely to represent new challenges for some manufacturers.
Do not forget the EUDAMED database!
The registration of the product in the EUDAMED database as well as the creation and maintenance of product labelling including a UDI (Unique Device Identification) is required.
The General Safety and Performance Requirements listed in Annex I
The "General Safety and Performance Requirements" specified in Annex I shall be justified on the basis of the general safety requirements described in Sections 1 and 8 which are to be understood as meaning that the product, when used in accordance with the conditions and purpose for which it is intended and while maintaining a high level of protection of the health and safety of persons, must not present a risk or a higher risk than the maximum permitted.
- In short form: The risk-benefit assessment regarding the products without an intended medical purpose must be also assessed as positive.
The novelty can also affect operators and users
According to the current interpretation, the change means that providers of cosmetic and aesthetic procedures and applications are subject to the German Medical Device Operator Ordinance (MPBetreibV) or its successors - with all their rights and obligations.
The BfARM is also likely to be responsible for the economic operators concerned in the event of reportable incidents involving products without an intended medical purpose.
Are you affected?
Are you affected by this innovation or are you not yet sure what impact this new legislation will have on you and your company? Or are you already one step ahead and are facing the task to perform a clinical evaluation or even a trial?
Please note that the details and bullet points listed are not intended to be exhaustive, are supplied without liability and only serve as information.