Medical device makers looking to bring new products to the European market will find a new layer of regulation before they can attain CE Mark approval.
The European Commission’s new hazardous substances restrictions now apply to medical devices for the 1st time, requiring that all products coming to the E.U. market after July 22, 2014, meet materials standards before they get market approval.
The new Restriction of Hazardous Substances (RoHS-2) document became law in July 2011 and took effect last year. The original RoHS rules exempted all medical devices, allowing them to contain unspecified amounts of materials deemed otherwise toxic. RoHS-2 now only fully exempts "active implantable medical devices," bringing materials used in in vitro diagnostics and other medical devices under regulatory oversight.
The RoHS-2 regulations took effect on July 21, 2011, but restrictions have been scheduled to phase in over several years. The medical device rules took effect this month and restrictions for in vitro diagnostics will take effect in 2016. The revisions will apply to all non-excluded electrical and electronic equipment in 2019.
The rules offer provide some limited exemptions for substances in other medical devices, such as the use of lead in X-ray systems and in protective shielding for ionizing radiation, cadmium in lasers and mercury in electrodes. Device makers can also apply for exemptions directly by making their case to the European Commission. (See the full list of exemptions in Annex IV, pg 36)
Medical devices already on the market before July 22, 2014, are protected for 5 years as they figure out how to achieve compliance. Medical products made adulterated under the new materials regulations can remain on the market until July 22, 2019, by which time they must either establish compliance or face prohibition. This measure spurred a market rush prior to this month’s deadline, where device makers and importers "stockpiled" new products in high volumes to win protection under the 5-year grace period, Law360.com reported.
The European Commission has been under pressure to rein in oversight of medical devices, especially after a 2011 scandal in which thousands of breast implants were found to contain hazardous materials associated with high rates of rupture. Late in 2011 French regulators discovered that Poly Implant Prothèse had been sneaking substandard silicone into its breast implants for more than a decade. French authorities launched a criminal investigation after receiving 2,000 complaints from women who received the PIP implants.