- Environmental law Overview: Electrical and Electronic Equipment Act (ElektroG) / Directive 2012/19/EU (WEEE Directive) Regulations for the MedTech industry

Name of the legal act

Act on the Placing on the Market, Return and Environmentally Sound Disposal of Electrical and Electronic Equipment (Electrical and Electronic Equipment Act – ElektroGExterner Link. Öffnet im neuen Fenster/Tab.).

Status

Electrical and Electronic Equipment Act of 20 October 2015 (BGBl. I p. 1739Externer Link. Öffnet im neuen Fenster/Tab.), which was last amended by Art. 1 of the Act of 8 December 2022 (BGBl. I p. 2240Externer Link. Öffnet im neuen Fenster/Tab.).

Background information

The ElektroG serves to implement Directive 2012/19/EU of the European Parliament and of the Council of 4 July 2012 on waste electrical and electronic equipment (WEEE Directive - consolidated version of 4 July 2018Externer Link. Öffnet im neuen Fenster/Tab.).

Scope of application

The ElektroG specifies product responsibility requirements for 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 electric currents or electromagnetic fields for its proper operation, i.e. that electric currents or electromagnetic fields are required to fulfil at least one of the intended functions of the device, [or] b) that serves to generate, transmit and measure such fields and currents " (Sec. 3 No. 1 ElektroG). Sec. 2 (2) ElektroG contains several exemptions from the scope of application, for example for medical devices and in-vitro diagnostics that are expected to become infectious before the end of their service life and for active, implantable medical devices (No. 11) and devices that were designed exclusively for research and development and are only made available on an inter-company basis (No. 9). There is no general exception for medical devices.

ATTENTION: The distinction between "b2c" and "b2b" appliances in the ElektroG does not follow the conventional definition. Rather, according to Sec. 3 No. 5 ElektroG ("waste equipment from private households" ("b2c") in distinction to waste equipment for use exclusively in households other than private households ("b2b")), it depends on whether a device can potentially be used in private households. If this is the case, it is a "b2c" appliance, regardless of to whom it is supplied and by whom it is actually used. See also distinction of the stiftung elektro-altgeräte register (Stiftung ear).

ATTENTION: The ElektroG does not apply to batteries. In the case of battery-operated electrical or electronic devices, both the BattG and the BattVO on the one hand, and the ElektroG and ElektroStoffV on the other hand, are 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 role is assigned to the producer according to Sec. 3 No. 9 ElektroG. The definition of 'producer' covers various scenarios and is very complex in itself. Accordingly, a producer is "any natural or legal person or partnership who, irrespective of the sales method, including remote communication methods

1. produces electrical or electronic devices under their name or brand and offers them in Germany, or designs or has them designed and offers them under their name or brand in Germany,
2. offers electrical or electronic devices from other producers under their own name or brand in Germany or resells them commercially, whereby the seller or reseller is not considered the producer if the name or brand of the actual producer appears on the device in accordance with letter a),
3. first offers electrical or electronic devices from another EU member state or a third country in Germany, or
4. offers electrical or electronic devices directly to end users in Germany using remote communication methods and is established in another EU member state or a third country.

Offering is the presentation or making available to the public of electrical or electronic equipment as part of a commercial activity aimed at the conclusion of a sales contract in Germany; this also includes the invitation to submit an offer.

In addition, distributors are also affected by numerous obligations. A distributor is "any natural or legal person or partnership that offers electrical or electronic equipment in Germany or makes it available on the market. This means that a producer is regularly also a distributor and must then fulfil both sets of obligations. ATTENTION: A mere distributor is considered a producer if he intentionally or negligently places electrical or electronic equipment of a producer not registered on the market according to Sec. 6 ElektroG.

Operators of electronic marketplaces and fulfilment service providers have also obligations under the ElektroG since 1 July 2023.

Duties in bullet points

Producer obligations:

• Product conception (Sec. 4 ElektroG)
• Registration (Sec. 6 ElektroG) + Financing guarantee for "b2c appliances" (Sec. 7 ElektroG) + Take-back concept for "b2b appliances" (Sec. 7a ElektroG)
• Labelling (Sec. 9 ElektroG)
• Take-back obligations (Sec. 16 ElektroG for "b2c devices" and Sec. 19 ElektroG for "b2b devices")
• Duty to provide information (Sec. 18 (4) ElektroG - new: Duty to enclose written information for "b2c devices" and Sec. 19a ElektroG for "b2b devices")
• Notification obligations (Sec. 27 ElektroG)
• Information obligations towards reuse facilities/treatment facilities (Sec. 28 ElektroG)

Distributor obligations:

• Use of the collection centre logoExterner Link. Öffnet im neuen Fenster/Tab. (Sec. 12 (2) ElektroG)
• Take-back obligation for "b2c appliances" in stationary and online retail if certain sales or storage/shipping areas are exceeded (Sec. 17 ElektroG)
• Information obligation regarding "b2c devices" in stationary and online retail (Sec. 18 (3) ElektroG)
• Notification obligations (Sec. 29 ElektroG)

Supplementary requirements for the export of electrical and electronic equipment that may be considered waste according to Section 23 in conjunction with Annex 6 of the ElektroG. Information on this can be found in the guidance document for contact points No. 1Externer Link. Öffnet im neuen Fenster/Tab..
Violations are regularly administrative offences.

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

Latest news

At EU level, feedback requested was in a general consultation processExterner Link. Öffnet im neuen Fenster/Tab. in preparation for a revision of the WEEE Directive. Based on this, the EU Commission announced that it would present a draft text for this revision in the second quarter of 2024, but this has not yet been published. It is not clear yet whether the WEEE Directive will also be converted into a regulation, but this does not seem unlikely. In any case, there will most likely be clarifications and possibly also extensions to the scope of application.

With the Directive (EU) 2024/884Externer Link. Öffnet im neuen Fenster/Tab., the WEEE Directive has been specifically adapted with regard to the obligation to bear the costs of historical waste equipment in order to comply with a judgement of the European Court of Justice. This particularly affects photovoltaic modules and products that did not fall within the scope of the ElektroG before 15 August 2018. Consultations are currently underway with the institutions involved. However, this does not necessitate an amendment to the ElektroG (see AnnouncementExterner Link. Öffnet im neuen Fenster/Tab. on the implementation of Directive (EU) 2024/884 of the European Parliament and of the Council of 13 March 2024 amending Directive 2012/19/EU on waste electrical and electronic equipment).

At national level, no current developments are recognizable. The draft billExterner Link. Öffnet im neuen Fenster/Tab. of a third law to amend the Electrical and Electronic Equipment Act is not taken forward by the new Federal Government.

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.