RoHS 2 is an update to the European Directive 2002/95/EC that limits the use of certain specified hazardous substances to be placed on the EU market from 1st January 2006. The new RoHS Directive 2011/65/EU (RoHS 2) became effective on 3 January 2013. RoHS 2 deals with the same hazardous substances and the same maximum concentration limits as Directive 2002/95/EC (RoHS 1).
Those affected by this Directive are producers of Electrical and Electronic Equipment (known as EEE). They must ensure that their products and the components of such products comply with the requirements of the Directive.
What impact will this have on Medical Device Manufacturers?
The scope of RoHS 2 is expanding to phase in some new and previously excluded categories. This includes medical devices and monitoring & control instruments, as well as certain cables. ROHS compliance for these categories of products will be phased in, Medical Devices have a deadline of 22nd July 2014 for compliance, In-Vitro Diagnostic Devices have a later deadline for compliance of 22 July 2016.
The six hazardous and restricted substances referred to in the RoHS Directive are:
- Hexavalent Chromium
- Polybrominated biphenyls
- Polybrominated diphenyl ethers (PBDE)
If you use any of these substances please refer directly to the directive for detailed explanations and concentration limits.
Are the any exemptions for Medical Devices?
Substitution or elimination of lead in the populated printed circuit boards of mobile medical devices is accepted as currently technically impracticable. A temporary exemption to allow the continued use of lead solders was added until further research can be carried out to identify alloys that are reliable for the normal life of mobile medical devices. An amendment to the original directive was added on 18th October 2013, as follows:
In Annex IV to Directive 2011/65/EU the following point 33 is added: ‘33. Lead in solders on populated printed circuit boards used in Directive 93/42/EEC class IIa and IIb mobile medical devices other than portable emergency defibrillators. Expires on 30 June 2016 for class IIa and on 31 December 2020 for class IIb.’
How will this be monitored?
Regulation 765/2008/EC includes obligations for all EU Member States to perform systematic market surveillance including “appropriate checks on product compliance on an adequate scale, by means of documentary checks and, where appropriate, physical and laboratory checks on the basis of adequate samples”.
Notified Body audits under the Medical Devices Directive will not include a review of technical documentation or Quality System documents and procedures related to RoHS 2 conformity.
How can BSI help me with RoHS?
BSI has developed a “RoHS Trusted Kitemark Service” to help you through the compliance process and to demonstrate conformity to the RoHS Directive.
There are two parts to this service:
- The first is the Pre-Assessment RoHS Trusted Service (PARTS). This comprises of:
- RoHS Awareness training and presentations
- Discussions of the legislations and relevant standards
- Assessment and Gap Analysis to BS EN 50581
- Review of technical file
- A full PARTS – RoHS Readiness Report.
You can take this as a stand-alone service, or you can use it as the first stage of obtaining the BSI Kitemark for RoHS.
If you wish to take the next step and gain the BSI Kitemark for ROHS then there are 3 key parts:
- The Material Control Plan – where we will review and assess the methodology used to ensure on-going RoHS compliance.
- On-going Analysis – based on the material control plan and risk analysis, selected items will be analysed for the presence of restricted substances to the RoHS Directive.
- On-going Assessment – this is the key aspect of any Kitemark Scheme, and a really important part of the RoHS Kitemark Scheme. Regular on-site audits will be carried out to ensure sustained implementation of the Material Control Plan as well as selected component analysis.
What can I do now?
If you think you may be affected by ROHS 2, visit the BSI Group website for further information.
Is there anything else I should know?
The medical device regulatory world is facing unprecedented change over the next few years, with rewriting of the three main Medical Device Directives, introduction of new requirements for Notified Bodies including the focus on Unannounced Audits. It is important you stay up to date with the implications of these changes. Further information can be found via the following links:
Latest update on the changes to the Medical Device Directives
Where can I get more information?
All EU official Documents can be downloaded via:
BSI has created a LinkedIn group to ensure that the information is shared in a timely manner, please sign up to BSI Global Medical Devices LinkedIn page to receive all the latest updates.
How can BSI help?
Should you have further questions regarding this update please contact your BSI Scheme Manager in the first instance. Thank you for your continuing support and participation.
BSI Global Product Manager