RoHS Act also concerns medical devices

The Act on Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment, or the RoHS Act (Restriction of Hazardous Substances Act, 387/2013), also concerns electrical and electronic medical devices. The RoHS Act and related Decrees of the Ministry of the Environment enforced the EU RoHS Directive (2011/65/EU) in June 2013. This Directive and its Delegated Directive (EU) 2015/863 limits the use of certain metals, plasticizers and fire retardants in electric and electronic devices. The requirements concern all electric and electronic devices that are not specifically excluded from the scope. 

The purpose of the limitations posed in the RoHS Directive and Act is to limit the harmful impact of hazardous substances on people and the environment. The limitations aim to reduce users’ exposure to hazardous substances in their work and to protect health. Another aim is to protect the environment and promote the recycling and disposal of devices.

Requirements of the RoHS Act on the manufacturers of medical devices

The RoHS Act poses requirements on economic operators concerning the compliance of devices, the preparation of EU declarations of conformity and technical documents and the CE marking.

Under the Medical Device Regulations (EU) 2017/7745 and (EU) 2017/746, medical devices must fulfil certain minimum requirements that concern their safety and performance, among other things. Materials and substances must fulfil physical, biological and chemical requirements that, for their part, ensure their safe use for both the patient and nursing staff. 

The Medical Device Regulations include specific requirements on the use of hazardous substances. The requirements concern substances or plasticizers that are carcinogenic, mutagenic or toxic to reproduction. These requirements do not restrict or exclude the requirements posed by the RoHS Act and Directive.

In addition to the requirements of the Medical Device Regulation, there are other regulations that pose restrictions and requirements on materials and substances. In addition to the provisions of the Medical Device Regulation, manufacturers’ devices can also be subject to other EU legislation, such as the RoHS Directive that requires an EU declaration of conformity. In this case, there must be demonstrable conformity with all EU Directives applicable to the device, and a single EU declaration of conformity must be drawn up.

Fimea oversees the conformity of medical devices, their use of the CE marking and compliance with RoHS as part of proactive and reactive market surveillance and as laid down by the Medical Devices Act (719/2021) and the RoHS Act (387/2013).

Read more

RoHS Act on the Fimea website (in Finnish)

Medical Devices Act 719/2021 (finlex.fi) (in Finnish)

Act on Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment 387/2013 (finlex.fi) (in Finnish)

MD Regulation EU/2017/745

IVD Regulation EU/2017/746