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Impacts on medical devices due to changes to the European Restriction of Hazardous Substances (RoHS) Directive
The European Restriction of Hazardous Substances (RoHS) Directive requires hazardous substances to be restricted in certain electrical and electronic equipment. The new RoHS Directive 2011/65/EU, entered into force on 21 July 2011, has now been implemented by European member states, and from 22 July 2014 the substance restrictions will gradually be extended to new product categories, including some medical devices which were previously excluded from the requirements of the Directive.
This means that from that date those electrical medical devices will need to comply with the RoHS Directive in order to bear the CE mark and be placed on the market in Europe. Further information and guidance about the RoHS Directive can be found on the European Commission website, Recast of the RoHS Directive.
Some medical device manufacturers and sponsors have raised questions about how this might impact medical devices supplied in Australia, where European CE certification has been used to support entry in the Australian Register of Therapeutic Goods (ARTG), and where those electrical medical devices will no longer be able to be supplied in Europe beyond 22 July 2014 because they are not able to comply with the RoHS Directive.
The TGA provides the following guidance in response to those questions:
- ARTG entries are not reliant on the medical device bearing a CE mark as such, but instead may be reliant on the manufacturer holding a CE certificate issued under the EU Medical Devices Directives. The manufacturer may have to meet other EU Directives in order to then apply the CE mark, but the presence of a CE mark itself is not a requirement of the Australian medical devices regulations.
- Other EU Directives such as the Restriction of Hazardous Substances (RoHS) Directive, the Machinery Directive, or Personal Protective Equipment Directive, are not relevant for the purposes of supplying medical devices in Australia.
- As long as the manufacturer maintains appropriate certification as evidence that they have applied a relevant Conformity Assessment (CA) procedure (such as a certificate issued under the EU Medical Devices Directives), then they will be able to continue to support ARTG entries where that certificate is used as manufacturer's evidence.
- In the event that the device manufacturer no longer holds relevant evidence of applying a CA procedure (for any reason), then they will need to obtain some other acceptable certification as supporting evidence for their ARTG entry.
- It may be possible for Australian sponsors to continue to supply medical devices that were manufactured prior to the CE certification no longer being valid; so long as the ARTG entry has not been cancelled, and there is evidence that the CA procedures had been applied to the devices at the time of manufacture.