Medtech Regulatory Update: Top Regulations and Standards to Prepare for in 2013

December 13, 2012 – 5:42 pm

As 2013 approaches, why not plan to make some New Year’s resolutions for your business, like a commitment to kick of 2013 by preparing for new medtech regulations and standards? The regulations and standards landscape in Europe for medical device manufacturers will change dramatically in the next few years. This blog post outlines some of the upcoming changes.

The Medical Device Regulations (MDR), which will replace the Medical Device Directive, are expected to be adopted before the 2014 European Parliament elections. It will, however, take several more years before the regulations come into full effect.

The British Standards Institution BSI has published a new international standard for the labelling of medical devices. The BS EN ISO 15223-1 will replace the BS EN 980:2008, which will be withdrawn on 31 January 2013. The new standard provides a set of internationally recognised symbols for the labelling of medical devices.

The EU Parliament approved a unitary patent proposal earlier this month. The patent could reduce the cost of an EU patent by up to 80%. The agreement will enter into force on 1 January 2014 or after 13 contracting states ratify the international agreement.

Medical devices will fall within the scope of the Restriction of Hazardous Substances Directive (RoHS) in 2014. Complying with RoHS is complicated and medtech manufacturers may need to make several changes to their manufacturing processes.

Medtech manufacturers will also need to comply with the Waste Electrical and Electronic Equipment (WEEE2) directive, which entered info force on 13 August 2012. A transition period will be in place until 14 August 2008, and member states have until 14 February 2014 to transpose the directive into national law, according to Eucomed.

By: Camilla Andersson

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