Consider and decide the intended purpose of your anticipated product. It is not for the user to decide the intended purpose but the manufacturer. Check whether the anticipated device fulfils the definition of a medical device in Article 2 (1). If it does, decide the classification in accordance with Article 51 and the rules contained in Annex VIII. Read the linked pages for more detailed explanations.
These initial decisions will influence many of the subsequent steps to be followed. It is therefore essential to take these decisions carefully and to be precise, especially if the product is likely to have a borderline medical purpose or could have a different classification depending on an interpretation of the rules.
Note: This definition also applies to devices offered to EU citizens via the internet (Article 6.), including diagnostic or therapeutic services.
Deliverables for demonstrating compliance:
(1) The rationale for deciding the product is a medical device,
(2) The statement of the intended purpose and users of the device,
(3) The device classification rational.
Guidance is also available from the Medical Device Coordination Group on borderline and classification questions:
- Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v3.
- MDCG 2022-5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.
- MDCG 2021-24 Guidance on classification of medical devices.
If, even as the manufacturer, you are unable to reach a decision on the classification of your future product, you can request a classification decision from your Competent Authority (of the Competent Authority of your authorised representative). The Competent Authorities have an agreed a procedure for handling such enquiries.
- Helsinki Procedure Helsinki Procedure for borderline and classification under MDR & IVDR
Guidance is also available from the Medical Device Coordination Group on the classification of software medical devices:
- Infographic Is your software a Medical Device?
- MDCG 2019-11 Qualification and classification of software - Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
How should we apply the new EU MDR directive for a medical device class 1 non measuring non sterile product that has already been on the market for tens of years.
Are there any guidelines for a product that is not under development but already on the market?
Thank you for your question about MDD Class 1 self-certified devices.
Medical devices that were Class I self-certified under the MDD and do not depend on the availability of MDR-designated Notified Bodies in order to comply with the MDR. These devices must comply with the EU MDR by the date of application, i.e., 26 May 2020.
For clarification: The legal concept of placing on the market refers to each individual product, not a type of product or model. It means your product has not, as you wrote, “already been on the market for ten years”, because each individual product can only be placed on the market (offered for sale/supply) after it has been manufactured. Please refer to the European Commission “The ‘Blue Guide’ on the implementation of EU products rules 2016”.
In the classification rules “7.5. Rule 18
All devices manufactured utilizing tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable, are classified as class III, unless such devices are manufactured utilizing tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact with intact skin only. ”
Which class is assigned to
“such devices are manufactured utilizing tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact with intact skin only. “
Thank you for your question about classification.
It means the classification of such devices is determined by the other classification rules, in the same way as the majority of devices are classified.
What is the class of sterile safety lancets and non-sterile specimen collection cups under new MDR?
Thank you for your question about classification
Unlike some countries and regions, the classification of devices in the EU is not decided by a central authority. Each device is classified by its manufacturer following a set of rules contained in the regulation. Sterile safety lancets would, most likely, be classified according to the rules in Annex VIII of the EU MDR (2017/745). Whereas, non-sterile specimen collection cups would, most likely, be classified following the rules of the EU IVDR (2017/746).
We will offer fall prevention for wheeled walkers and rollators. The fall prevention technology is mounted inside the rear wheels. Does our technology go under MDR when the purpose is disability and injury prevention.
It seems likely but maybe as an accessory, depending on whether the wheeled walkers are already classed as medical devices or if you will be changing (the intended purpose of) the original product into a medical device. Either way, you should develop a clear rationale / justification for the decision that your device is/is not a device or an accessory. Please see the example methodology on the on the linked page for making such a decision.
Our device is procedure packs and sterile. Thus, our device classification is Class 1 Rule 1. Is it correct? Does the class 1 requires Clinical evaluation as well?
A procedure pack is a combination of devices and persons who combine devices only have to follow the rules in Article 22.
As long as all the devices in the procedure pack are CE marked, there is no need to perform a clinical evaluation because the manufacturers of each device have already performed the clinical evaluation for each device. However, if the pack contains non CE marked devices, then the whole pack is considered to be a new device and the producer must fulfill all the obligations EU MDR applicable to manufacturers, not only the clinical evaluation.
We manufacture and sell adhesives that are used in many devices, including medical devices. One of our customers is asking us to provide an “EU MDR” declaration for one of our adhesives. The adhesive is a liquid or gel when it leaves our facility and once the end-user receives it, they “cure” it into a solid, so the properties are changed. What should the “declaration” include? Do we have to declare anything, as we are manufacturing and selling a chemical that is exempt from CE marking? Because we do not manufacture the medical device itself, is the EU MDR even applicable to us?
An EU declaration of conformity (as required by the EU MDR) can only be issued for a compliant medical device by its manufacturer. Based on what you write; it seems that your company does not produce medical devices and therefore the EU MDR cannot apply.
May I confirm if a hydrogel patch containing a majority of water content (upwards of 30%) and some herbal substance/preparation (they are volatile in nature, including menthol and peppermint oil), with a principal mode of action which is physical, i.e. by evaporation of water and the volatile components, causing a cooling effect is still a medical device based on the MDCG 2022 April issue? – https://health.ec.europa.eu/system/files/2023-06/mdcg_2022-5_en.pdf
Since menthol (while having a pharmacological effect on cold receptors, if used separately), was not added with an intended medical purpose, but rather to aid in the evaporation process? Thank you.
Ultimately it is the manufacturer who decides. So, as long as you have a sound rationale for deciding the product is a medical device, you are able to classify the device according to the classification rules and able to define the intended (medical) purpose and users; you are in a position to proceed with the next steps.
If you are really unable to decide yourself, you can write to your Competent Authority (or the Competent Authority of your authorised representative) and ask their opinion. But ultimately, it is the manufacturer who decides.
“7.5. Rule 18
All devices manufactured utilising tissues or cells of human or animal origin, or their derivatives, which are non-viable or rendered non-viable, are classified as class III, unless such devices are manufactured utilising tissues or cells of animal origin, or their derivatives, which are non-viable or rendered non-viable and are devices intended to come into contact with intact skin only.”
Was the wording “tissues or cells of human or animal origin, OR their derivatives” chosen by accident only, given that Art. 1 (6) lit. g of Reg. (EU) 2017/745 states the following?:
“transplants, tissues or cells of human origin, or their derivatives, covered by Directive 2004/23/EC, or products containing or consisting of them; however this Regulation does apply to devices manufactured UTILISING DERIVATIVES of tissues or cells of human origin which are non-viable or are rendered non-viable”
Directive 2004/23/EC covers the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells intended for human applications. The EU MDR does not apply to such materials undergoing such activities; they are not medical devices. However, if medical devices are manufactured utilising derivatives of such materials the EU MDR does apply; they are medical devices. The decision, whether the EU MDR applies, is dependent on the way the materials are used, not the materials per se.