New basis for CE marking of medical devices
This article first appeared in Going Public Magazine 15 Nov 12.
RoHS Directive 2011:
The EU declares war on pollutants in medical devices: With the amendment to the EU Directive on the prevention of pollution from electronic equipment (RoHS II), lead, mercury, cadmium and other hazardous substances will be banished from medical devices. As of July 2019, only products that meet the requirements of RoHS II may be manufactured and marketed in the EU.
Since 2006, it is mandatory for manufacturers of electrical and electronic equipment to observe the limits of the first RoHS Directive 2002/95/EG for certain hazardous substances. RoHS stands for: Restriction of the Use of certain Hazardous Substances in Electrical and Electronic Equipment. With the entry into force of the new RoHS II Directive 2011/65/EU on 21 July 2011, its scope has been extended in order to include electro-medical devices. The EU Member States must have implemented the Directive by 2 January 2013 at the latest into their respective national law; a respective ministerial draft was submitted to the German Federal Government on 25 September. However, transitional periods do exist: Medical device manufacturers who still want to place their devices within the EU need to have implemented the new requirements by 22 July 2014. For in vitro diagnostic medical devices, the applicable deadline is 22 July 2016. Explicitly excluded from the scope of this Directive are active implantable medical devices.
In Germany, the costs related to the conversion for manufacturers are estimated at 250 million euros and the annual compliance costs at 40 million euros. With regard to the medical industry, however, lower costs are expected, since medical devices often contain components that were subject to limitations in the past.
Compliance with the regulatory limits
For electro-medical devices, including cables and spare parts, (as from July 2014) and for in vitro diagnostics (as from July 2016), the following maximum concentration values apply:
|Polybrominated biphenyls (PBB)||0.1%|
|Polybrominated diphenyl ethers (PBDE)||0.1%|
*Maximum concentration values tolerated by weight in homogeneous materials
For certain purposes and with regard to electrical and electronic equipment, RoHS II provides exemptions - mostly temporary - to these concentration limit values. Pertaining to medical devices, the Directive has a separate Annex IV, which currently lists 20 additional exemptions, such as with respect to cadmium in helium-cadmium lasers or lead in solders for bonding to ultrasonic transducers. These exemptions are currently limited to a period of seven years from the dates already mentioned. These exemption deadlines may be reduced retrospectively for specific uses, for example, if a reliable substitute is available. Manufacturers can file an application to the European Commission for granting other exemptions or renewal of existing exemptions. This will be an option in special cases, in which the amount limitations for the respective substances are not feasible for scientific or technical reasons, or if unreasonable adverse health safety impacts would be caused in case substitutes were used.
The RoSH II requires every manufacturer to implement a RoSH II requirements conformity assessment and to provide technical documentation showing that the device complies with the substance limits. Where compliance of the applicable requirements is demonstrated, the manufacturer provides an EU declaration of conformity, in which he confirms that the product complies with the RoSH II Directive, and affixes the CE marking to the finished product. The manufacturer indicates, by having affixed the CE marking, that he assumes responsibility for the conformity of the product. The re-examination of the RoHS II compliance can be integrated into the medical device conformity assessment procedures to be performed and a joint declaration of compliance can be provided.
Additional obligations for manufacturers and agents
Other duties manufacturers are obliged to obey pertain to production control, labelling obligations, presentation and information requirements vis-à-vis the competent authorities, post market surveillance obligations, application of corrective measures in case of non-compliant devices and product recall. The RoSH II does not only provide a catalogue of new requirements for medical device manufacturers, but also for authorized representatives of the manufacturer, importers and distributors. They are only allowed to place equipment in the market which meets the RoSH II requirements. For this purpose, they must ensure that the manufacturer fulfilled its obligations. In case a suspicion of non-compliance with the requirements exists, they are obliged to perform the necessary remedies and inform the competent authorities.
While implementing these rules into national law, the EU Member States must stipulate sanctions to be imposed in the event of violations of the admissible limits. The German ministerial draft provides for a fine of up to 100,000.00 Euros in the event of a violation of the stipulated requirements.
Written by Friederike Pavese, Senior Associate, Field Fisher Waterhouse LLP