On 9 January 2014 a total of 16 amendments to the RoHS Directive were published. 15 amendments affecting medical devices (Annex IV) were issued and there is a new exemption for mercury in certain compact fluorescent lamps which was included in RoHS Annex III.
The codes of the issued amendments are Commission Delegated Directive 2014/1/EU to 2014/16/EU. Directive 2014/14/EU deals with mercury content of single capped fluorescence lamps. This Directive amends the general RoHS Annex III whereas the other amendments affect Annex IV of RoHS recast for medical devices.
RoHS Recast and Medical Devices
In accordance with Article 4(1) of the RoHS recast (1) Member States shall ensure that electrical and electronic equipment placed on the market, including cables and spare parts for its repair, its reuse, updating of its functionalities or upgrading of its capacity, does not contain the restricted substances beyond the thresholds set in Annex II of RoHS recast. Because of various reasons, such as the reliability of the substitutes, the negative impact to human health or environment or technical barrier, etc. so the amendments of Annex IV of RoHS recast specific to medical devices are necessary.
Annex IV is separated into 3 groups. They are:
- Group 1: Equipment utilizing or detecting ionizing radiation
- Group 2: Sensors, detectors and electrodes
- Group 3: Others
The exemptions for the above mentioned second and third groups were revised during this serial amendment. The point 12 of Annex IV of RoHS recast is replaced with a new one. 14 new exemptions from the point 21 to 34 are added to the third group. In addition all the amendments have accompanied expiry dates.
According to the Article 2 of all the above mentioned amendments, Member States shall bring into force the laws, regulations and administrative provisions necessary to comply with RoHS recast by the last day of the sixth month after these amendments entering into force at the latest.
SGS has consolidated all the exemptions specific to medical devices below. Applications exempted from the restriction in Article 4(1) specific to medical devices and applications exempted from the restriction in Article 4(1) specific to mercury in single end capped fluorescence lamps are given in Tables 1 and 2 within the latest SafeGuardS bulletin.