- Environmental law Overview: Electrical and Electronic Equipment Substances Ordinance / Directive 2011/65/EU (RoHS Directive) Regulations for the MedTech industry

Name of the legal act

Ordinance on the restriction of the use of hazardous substances in electrical and electronic equipment (Elektro- und Elektronikgeräte-Stoff-Verordnung - ElektroStoffVExterner Link. Öffnet im neuen Fenster/Tab.).

Status

Electrical and Electronic Equipment Substances Ordinance of 19 April 2013 (BGBl. I p. 1111Externer Link. Öffnet im neuen Fenster/Tab.), last amended by Art. 21 of the Act of 10 August 2021 (BGBl. I p. 3436Externer Link. Öffnet im neuen Fenster/Tab.).

Background information

The ElektroStoffV serves to implement Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS Directive - consolidated version of 01.01.2025Externer Link. Öffnet im neuen Fenster/Tab.).

Scope of application

According to Sec. 1 (1), the ElektroStoffV applies to all electrical and electronic equipment. This is "a device that is designed for operation with alternating current of no more than 1,000 volts or for operation with direct current of no more than 1,500 volts and a) that is dependent on electrical currents or electromagnetic fields for its proper operation, i.e. that electrical currents or electromagnetic fields are required to fulfil at least one of the intended functions of the device, [or] b) to generate, transmit and measure such fields and currentsis used" (Sec. 2 No. 1 ElektroStoffV). Sec. 1 (2) ElektroStoffV contains several exceptions from the scope of application, for example for active, implantable medical devices (No. 8) and devices that are designed exclusively for research and development and are only provided on an inter-company basis (No. 10). There is no general exception for medical devices.

ATTENTION: The ElektroStoffV is not applicable to batteries. For battery-operated electrical or electronic devices, the BattG and in particular the ElektroG and ElektroStoffV are therefore generally applicable in parallel. The stiftung elektro-altgeräte register provides details on the distinction in an application guideExterner Link. Öffnet im neuen Fenster/Tab..

Roles

The central actor is the producer, i.e. "any natural or legal person or partnership that manufactures an electrical or electronic appliance or has it developed or manufactured and markets it under its own name or brand" (Sec. 2 No. 5 ElektroStoffV). The producer does not have to be based in Germany or the EU.

The importer also has an important role to play. An importer is "any natural or legal person or partnership established in the European Union who offers or places on the market electrical or electronic equipment from a third country" (Sec. 2 No. 8 ElektroStoffV).

Finally, the distributor is also subject to certain obligations defined as "any natural or legal person or partnership, other than the producer and the importer, who offers an electrical or electronic appliance or makes it available on the market” under Sec. 2 No. 7 ElektroStoffV.

In the context of the ElektroStoffV, placing on the market only covers "the first making available of an electrical or electronic appliance on the market for distribution, consumption or use"

Further information can be found in the EU Commission's FAQsExterner Link. Öffnet im neuen Fenster/Tab..

Duties in bullet points

Compliance with substance restrictions (Sec. 3 (1), (3) and (4) and Sec. 4 (1) ElektroStoffV)

• Concerns lead, mercury, hexavalent chromium, PBB, PBDE, DEHP, BBP, DBP, DIBP (limit value 0.1 per cent by weight in each case) and cadmium (limit value 0.01 per cent by weight)
• The reference point is any homogeneous material = "material of uniform composition throughout or a material, consisting of a combination of materials, that cannot be disjointed or separated into different materials by mechanical actions such as unscrewing, cutting, crushing, grinding and abrasive processes"
• Specific exceptions from the substance restrictions according to Annexes III and IV RoHS (especially Annex IV relevant for medical devices)
• Transitional provisions in Sec. 15 ElektroStoffV
• Presumption of conformity - in particular, compliance with DIN EN ISO 63000

Producer obligations (particularly Sec. 4 ElektroStoffV):

• Preparation of technical documentation (Sec. 3 (2) No. 1 ElektroStoffV - combined documentation possible if this is also required under other legislation)
• Internal production control
• Issue of the EU Declaration of Conformity (Sec. 11 ElektroStoffV)
• Affixing the CE marking (Sec. 12 ElektroStoffV)
• Correction and notification obligation in the event of indications of non-compliance (Sec. 4 (5) ElektroStoffV - including withdrawal/recall if necessary)
• Labelling (Sec. 5 ElektroStoffV)
• Retention of and access to documents

Importer obligations (Sec. 7 ElektroStoffV):

• Check whether technical documentation has been prepared, CE marking affixed, labelling in accordance with Sec. 5 ElektroStoffV
• Own labelling obligation
• No placing on the market or obligation to correct and notify in the event of indications of infringements
• Retention of and access to documents

Distributor obligations (Sec. 8 ElektroStoffV):

• Check whether CE marking is affixed, producer/importer labelling
• No placing on the market or obligation to correct and notify in the event of indications of infringements

Violations may lead to a traffic ban and are regularly administrative offences.

Latest news

A legislative procedureExterner Link. Öffnet im neuen Fenster/Tab. is currently underway at EU level to simplify and improve substance and exemption assessments under RoHS. The content of the revision is expected to focus on the following: reform of the procedure for exceptions, inclusion of new substance restrictions, reform of the process (possibly involving the European Chemicals Agency (ECHA)), changes to the provisions for spare parts, clarification of the scope of application, and provisions on the use of recycled materials and critical raw materials.

With regard to numerous exemptions from the substance restrictions (in particular for the central excemptions from points 6 and 6 of Annex III RoHS), there were consultations in January 2025 to decide on their extension, but the relevant decisions have not yet been officially announced by the EU Commission. As a result, the exemptions will continue to apply for the time being until the relevant amending acts are published.

Imprint

© Bundesverband Medizintechnologie e.V. (BVMed), the German MedTech Association, in cooperation with the law firm "Ahlhaus Handorn Niermeier Schucht Rechtsanwaltsgesellschaft mbH" („Produktkanzlei“).

This overview does not replace an individual case assessment.