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MedTec Finalist Hessen Champions 2018

REACH conformity – Medical technology

REACH is a directive of the European Union that was issued in order to further the protection of human health and environment from the risks of chemicals. In principle, REACH applies to all chemicals, not only those used in industrial processes, but also those of daily life such as cleaning products, paints as well as clothing, furniture and electrical appliances. The regulation therefore has an impact on most businesses in the EU.

All MBST magnetic resonance therapy systems use REACH compliant materials wherever necessary.

REACH · Registration, Evaluation, Authorisation and Restriction of Chemicals

REACH stands for Registration, Evaluation, Authorisation and Restriction of Chemicals. The directive took effect on June 1, 2007. REACH replaces more than 40 laws and regulations existing in the European Union.

MBST magnetic resonance therapy devices are REACH compliant wherever necessary

Since patients have direct contact with MBST magnetic resonance therapy devices, REACH conformity is a prerequisite. REACH-compliant materials are used in all our medical products wherever it is necessary due to direct contact for patients and staff. MedTec Medizintechnik thus completely fulfills REACH regulations.

Burden of proof on companies

REACH places the burden of proof on the companies. To comply, the companies have to identify and control any risks posed by the substances they produce and place on the market within the EU. For all substances, they must demonstrate to the ECHA (European Chemicals Agency) how it can be used safely and must inform users about necessary risk management measures.

REACH compliance

REACH’s objective is the regulation of substances of very high concern. Such substances must pass a process of approval that is defined in the REACH directive. After a transitional period, such substance may only be used after approval. The so-called "candidate list" states the substances that require approval. This list was first published on October 28, 2008 on the ECHA website and since then has been continuously updated. With the coming into effect of REACH, we are also obliged to communicate the information if a product contains a substance from the so-called "candidate list" in a concentration of more than 0.1% by mass.

Protection and well-being of patients are MedTec’s top priority. At present and in the future, our MBST magnetic resonance therapy devices do not contain any substance that is listed on the candidate list.