Table of Contents

Beyond the MDR and the IVDR

In addition to the requirements of the MDR (Regulation (EU) 2017/745) and the IVDR (Regulation (EU) 2017/746), medical device companies that want to place their products in the European Union (EU) market may be subject to other EU directives, EU regulations or other national requirements addressing the control and recycling of the electrical and electronic waste and chemical substances. These include:

These directives and regulations are discussed here. 

The European WEEE Directive

Any company (including in the medical device field) placing electrical devices on the European Union (EU) market must comply with the Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE).

In substance, the goal of the WEEE Directive is to minimize the impact of electrical and electronic goods on the environment by increasing the reuse and the recycling and reducing the amount of waste of electrical and electrical equipment going to the landfill.

The specific symbol below (Fig 1.) indicates that the product should not be discarded as unsorted waste but must be sent to separate collection facilities for recovery and recycling. The WEEE marking must appear on any electrical and electronic equipment placed on the EU market. 

Fig 1. The WEEE marking (crossed-out wheeled bin)

The European RoSH2 Directive

The Directive 2011/65/EU on Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS2) aims to reduce the levels of lead, cadmium, mercury, hexavalant chromium, polybrominated biphenyl (pbb) and polybrominated diphenyl ether (PBDE) flame retardants in products.

In 2017, RoHS2 was amended (introduction of modification) by the Directive (EU) 2017/2102. By consequence, both RoHS2 and Directive (EU) 2017/2102 must be followed.

RoHS2 is a CE Mark directive. This means that a medical device company needs to place a CE Mark on each of its products to confirm that it has taken the appropriate measures to meet RoHS2 requirements, restrictions and provisions.

Medical device companies are responsible for providing conformity assessments, a Declaration of Conformity (DoC) and the Technical Documentation. A reference to the RoHS2 Directive could be added to a current DoC referring to the MDR or to the IVDR, where applicable.

The European Batteries Directive

The Directive 2006/66/EC on Batteries and Accumulators and Waste Batteries and Accumulators (known as the Batteries Directive) regulating the manufacturing and disposal of batteries and accumulators in the EU to protect human health and the environment from hazardous substances such as mercury and cadmium. 

As described by the European Commission, the Batteries Directive prohibits the marketing of batteries containing some hazardous substances, defines measures to establish schemes aiming at high level of collection and recycling, and fixes targets for collection and recycling activities. The Directive also sets out provisions on labelling of batteries and their removability from equipment.

It also aims to improve the environmental performance of all operators involved in the life cycle of batteries and accumulators, e.g. producers, distributors and end-users and, in particular, those operators directly involved in the treatment and recycling of waste batteries and accumulators. Producers of batteries and accumulators and producers of other products incorporating a battery or accumulator are given responsibility for the waste management of batteries and accumulators that they place on the market.

The EU Commission proposed a new Batteries Regulation on 10 December 2020. This Regulation aims to ensure that batteries placed in the EU market are sustainable and safe throughout their entire life cycle.

The European Packaging and Packaging Waste Directive

The Directive 94/62/EC on Packaging and Packaging Waste requires manufacturers to prevent the formation of packaging waste, to ensure that the eight and volume of packaging placed on the market is limited to the minimum and to develop packaging reuse systems to reduce their impact on the environment (restriction of the presence of certain heavy metals in packaging).

In 2018, this directive was amended (introduction of modification) by the Directive (EU) 2018/852. By consequence, both Directive 94/62/EC and Directive (EU) 2018/852 must be followed.

The European REACH Regulation

The Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulates the registration, evaluation, authorisation and restriction of chemical substances in the EU market.

REACH aims to improve the protection of human health and the environment through the better and earlier identification of the intrinsic properties of chemical substances.

REACH is a global directive. In contrast, RoHS2 is a specific directive focused on the restriction of certain hazardous substances in waste electrical and electronic equipment.

RoHS2 doesn’t not affect the application of REACH and REACH doesn’t not affect the application of RoHS2.

When overlaps occur, the strongest restriction should be applied. Moreover, exemptions from the substance restrictions in RoHS2 may not be granted if they result in a lowering of the environmental and human health protection afforded by REACH.

Recommended Reading

Sources & References

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