The new European Union RoHS Recast Directive that comes into force on July 22 applies to all medical devices. The devices have to comply with some restrictions on certain metals that can become toxic and leach into groundwater, or become hazardous ash when incinerate. The banned materials include lead, cadmium, mercury and polybrominated flame retardants, which are commonly found in the electrical components of medical equipment.
The first RoHS Directive was introduced in 2003 and applied to information technology equipment, such as computers and printers. Medical equipment was exempt at that time. Even if it seems a logical step, it is not enough to simply modify products to comply by removing the hazardous and restricted substances. All economic operators (manufacturers, importers, distributors, and authorized representatives), are required to provide proof of RoHS Recast verification on various forms of technical documentation.
Anything you declare in the EU as a medical device must be compliant by July 22nd. However, medical devices placed on the EU market before RoHS restrictions, once repaired or upgraded, do not need to be RoHS compliant, as long as the device is made available as “used”, “pre-owned”, or “refurbished”.
CE Medical, in partnership with Certification Experts BV, is a technical and legal certification company specialized in the CE Marking of Medical Devices. CE Medical has expertise in all procedures required to arrive at a successful CE marking certification and offers full assistance to gain the CE Mark of your Medical Device products.