20 Dec 2017

While Medical Device manufacturers have had complex rules governing the manufacture and sale of their products, they have been exempted from most environmental regulations regarding hazardous substances. However, with the extension in scope of European Union’s (EU) ‘Directive 2011/65/EU’ in July 2014, RoHS compliance became mandatory for Medical Device manufacturers.

‘Directive 2011/65/EU’ (RoHS2 recast) focuses on the restriction of the use of certain hazardous substances in electrical and electronic equipment, thereby requiring every manufacturer selling to the EU market to re-evaluate their inventory and ensure compliance with the recast RoHS and WEEE directives.

Medical Device manufacturers are obligated to ensure and demonstrate compliance with the directive. The implications of Non-Compliance to the RoHS2 directive are grave and will prevent the product from carrying a ‘CE’ mark and eventual removal of the product from the market.

In order to demonstrate compliance to the RoHS2 recast, Medical Device Manufacturers are required to

  • Define their product and identify the directives applicable to it
  • Source RoHS compliant material from suppliers & analyse and identify material changes needed to comply with the RoHS2 directive
  • Show proof of compliance to RoHS2 recast by drawing up required technical documentation surrounding their product including conformity risk assessment report, test reports for each part
  • Cite relevant harmonized standards applicable to the device
  • Maintain a register of non-conforming products
  • Provide explanations as to why certain parts do not include test reports
  • Analyze their internal production and implement an appropriate internal production control procedure in line with the recast
  • Draw up an EC declaration of Conformity and affix the ‘CE’ mark on the finished product
  • Be wary of new materials introduced to the medical equipment and ensure that the equipment is tested & re-certified
  • Include a complete evaluation of the product against the list of Restricted Substances by 2014

Medical Device Manufacturers now facing the daunting task of understanding the RoHS2 directive, identifying the rules and regulations impacting their products and providing relevant documentation to demonstrate full compliance. Medical Device Manufacturers have to get comfortable with requirements of RoHS2 directive as fast as they can in order to maintain their competence in EU market.