MDR—Medical Device Regulation - Babyleo TN500 in a real clinical scenario — MDR—Medical Device Regulation
Contact

EU Regulation 2017/745 governs a wide range of new requirements for medical devices with the aim of further strengthening patient protection. The Medical Device Regulation has applied to all EU member states since 2020.

Special provisions apply to products or product components and their materials that:

are applied invasively and come into direct contact with the human body,
(repeatedly) administer or remove medicines, body fluids, or other substances, including gases, from the body; or
transport or store such medicines, body fluids, or other substances, including gases, that are (repeatedly) administered to the body

For Dräger products, this applies to components in medical devices that come into contact with the patient via the breathing gas. These products or product components and their materials may only contain certain substances in a concentration > 0.1 percent, if this is permitted according to specific rules.

The following substances are relevant in this context:

a) substances that are carcinogenic, mutagenic, or toxic to reproduction (“CMR substances”) in category 1A or 1B according to Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CLP Regulation), or

b) substances with endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health, provided they are listed as SVHC (Substance of Very High Concern) in the Candidate List (REACh)

Why am I affected as a supplier?

For medical devices or product components and their materials in medical devices which come into contact with the patient as described above, special declaration obligations apply if a concentration of 0.1 percent (w/w) is exceeded.

Suppliers preferably provide information with regard to parts that potentially contain materials and substances affected by the regulation.

If you are a supplier of such products or product components, you must submit a substance declaration for them. Dräger will let you know if this applies to your products as part of the purchasing process.

What does the concentration limit of 0.1 percent (w/w) refer to?

For the purposes of the Regulation, the concentration limit refers to the material used in the product or product component. If the product or product component consists of several materials, you must check whether these individual materials contain the relevant substances.

Why is a REACh declaration not sufficient?

Article 33 of the REACh Regulation governs communication obligations within the supply chain. However, this communication obligation only relates to substances on the candidate list (Substances of Very High Concern—SVHC). The MDR covers a much more extensive range of substances.

As a supplier, I do not know if my item or parts of my item will come into contact with the patient through fluids. What do I do in this case?

Contact the responsible buyer. The buyer will be able to provide information directly or arrange a technical discussion with the responsible developer.

What are my obligations as a supplier to Dräger?

Your obligation is to:

provide information about the above-mentioned substances to Dräger, if products or product components that come into contact with the patient are concerned
immediately notify us of any changes to materials or the substances in materials

Which substances need to be declared?

substances that are carcinogenic, mutagenic, or toxic for reproduction (“CMR substances”) in category 1A or 1B according to Part 3 of Annex VI to Regulation (EC) No 1272/2008 (CLP Regulation), or
substances with endocrine-disrupting properties for which there is scientific evidence of probable serious effects to human health, provided they are listed as SVHC (Substance of Very High Concern) in the Candidate List (REACh).

You can download a complete list of all relevant substances here:

Download list

How do I proceed as a supplier?

a) If your products or product components that you supply to Dräger come into contact with the patient, then:
Fill out the MDR form (see below) and return it to the responsible buyer by the stated deadline.

b) If you do not have the necessary information about whether your products meet the concentration limit of 0.1 percent (w/w) of the above-mentioned substances, then:

Contact your suppliers and obtain the necessary information from them.