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SGS Announces EU to Amend Exemptions on RoHS for Medical Devices (Annex IV) and Fluorescent Lamps (Annex III)

From 22 July 2014 medical devices and from 22 July 2016 IVD need to comply with the RoHS recast (1). Due to various reasons, such as safety, a negative impact to environment or no substitutes, etc. the European Parliament and the Council have amended Annex IV of RoHS recast “2011/65/EU” (1).

New Taipei City, Taiwan, February 24, 2014 --(PR.com)-- Amendments to RoHS Recast

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 (newsletter.sgs.com/eNewsletterPro/uploadedimages/000006/sgs-safeguards-01714-exemption-of-rohs-recast-for-medical-device-a4-en-14.pdf) within the latest SafeGuardS bulletin.

Reference:

(1) RoHS recast (eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2011:174:0088:0110:en:pdf)

About SGS Electrical and Electronics Services

SGS is committed to keeping readers up to date on the latest regulations and policies concerning the use of hazardous substances in medical devices (sgs.com/en/Consumer-Goods-Retail/Medical-Devices.aspx). Furthermore, through its global expertise and network of chemical labs, SGS can provide support in ensuring that products comply with relevant hazardous substances requirements on all relevant markets around the world.

Whether for hazardous substances testing or other third party verification, certification or inspection services, SGS is ideally positioned to satisfy all business's needs.

Please do not hesitate to contact the SGS experts for further information.

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 80,000 employees, SGS operates a network of over 1,650 offices and laboratories around the world.
Contact Information
SGS CTS
Richie Chang
+886 2 22993279
Contact
www.sgs.com/ee
Supervisor
125, Wu Kung Road
New Taipei Industrial Park, Wu Ku District
New Taipei City
24886, Taiwan

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