On 17 July 2015, the Council and the European Parliament published a latest version of their Proposal for a Regulation on medical devices and amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009.
In this context, it is important for the industry to be aware of the ongoing legislative discussions at the EU level which may adversely affect medical devices manufacturers/importers in the EU inasmuch as they may result in a new restriction on the use of the plasticizer DEHP in medical devices.
By way of brief background, at the moment DEHP can still be incorporated in medical devices without any particular restriction or obligation. Indeed, although such substance was placed on the REACH authorisation list (Annex XIV) based on its reproductive toxicity properties, this does not apply to medical devices which therefore remain exempted from the need to obtain an authorisation. However:
- On 31 March 2015 DEHP has been added to the list of restricted substances pursuant to Directive 2011/65/EU ("RoHS II"). As a result, the use of DEHP in medical devices is restricted to 0.1% w/w as of 21 July 2021. Medical devices containing DEHP above that threshold shall no longer be placed in the market after that date. Nevertheless, there is a possibility to seek an exemption for specific categories of medical devices, upon request, following a notification procedure with the Commission.
- In October 2015 the Commission will discuss the possible inclusion of DEHP in the REACH Authorisation list (Annex XIV) also on the basis of its endocrine disruption (''EDs'') properties linked to environmental concerns. Reportedly, this may adversely affect also the current exemption from authorisation for medical devices in light of the identification of the new risk category. As a result, the Commission may lift the exemption and extend DEHP authorisation requirements to medical devices.
- Lastly, as noted, the Commission is also working on a reform of the Medical Devices regulatory framework. This is a longer-term activity and there will be a series of meetings and discussions in the autumn. It is necessary to make sure there are no new provisions restricting the use of DEHP (or other substances) in relation to medical devices; otherwise the possible exemptions under RoHS or REACH will be worthless.
It is clear from the above that the Commission is willing to reduce as much as possible the presence of DEHP on the market.
With that in mind, we believe it is of utmost importance for EU medical device manufacturers/importers to react promptly before such restrictions are in place by either lobbying against or preparing for requests for exemptions. Possible lines of action to do so could be (i) monitoring developments at the EU level; (ii) setting up industry coalitions to work on the exemptions under RoHS and (iii) lobbying with the Commission to ensure that the current exemption under REACH is not withdrawn and no restrictions on use of DEHP are included in the draft reform for Medical Devices Directive.