European Medical Devices Regulations (2017/745)

It involves harmful substances in medical devices. It was officially implemented on May 26, 2021.

Target:

Medical Devices Regulation (EU) 2017/745 (“MDR”) introduces significant provisions regarding the regulation of carcinogenic, mutagenic or reproductive toxicity (CMR) and/or endocrine disruptor substances. According to MDR, the concentration of CMR and/or endocrine disturbing substances contained in medical devices shall not exceed 0.1% of the weight of the component (w/w). Nanomaterials should be considered additionally unless they only come into contact with intact skin.

Product range:

Equipment or components thereof or materials used therein that comply with the following criteria:

• They are invasive and come into contact with the human body directly.
• They (re)administer drugs, body fluids or other substances (including gases) to/from the body.
• They transport or store such drugs, body fluids or substances (including gases) for (re)administration to the body.

Equipment must be designed and manufactured in such a way that the risks associated with substances or particles must be minimized, including wear debris, degradation products and processing residues that the equipment may release.

In addition, the following substances contained in medical devices shall not exceed 0.1% of the weight of the product (w/w):

1. Carcinogenic, mutagenic or reproductive toxicity (CMR) substances, as defined in CLP Regulation (EC) No 1272/2008 Part 3, are classified as 1A or 1B.
2. It is determined as an endocrine disturbing substance under REACH Regulation (EC) No 1907/2006 and Regulations on Bactericidal Products (EU) No 528/2012.

The current list contains over 1000 substances and will be updated every six months to include new additions or revisions.

Manufacturer's liability when exceeding the 0.1% w/w threshold

The manufacturer needs to do the following:

1. Conduct benefits-risk assessments and provide reasons in technical documents.
2. The presence of these substances is clearly marked on the device itself and/or on the packaging of each unit. Or, if applicable, the label shall be placed on the sales packaging along with a list of such substances.
3. Includes instructions tailor-made for patient groups who are particularly susceptible to these substances.
4. Ensure maintenance of the UDI (Unique Device Identification) online database containing relevant information about medical devices.

By fulfiling these obligations, manufacturers can meet regulatory requirements and ensure the safety and transparency of their medical devices.

 

Ahmed Sakr

Product Compliance Consultant

ComplyMarket UG (haftungsbeschraenkt)