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The majority of medical devices intended for the European Economic Area (EEA) markets are governed by the requirements of the Medical Device Directive (MDD) 93/42/EC as amended (most recently via Directive 2007//47/EC). The MDD defines ‘authorised representative’ in Article 1.2(j) as meaning “any natural or legal person established in the Community who, explicitly designated by the manufacturer, acts and may be addressed by authorities and bodies in the Community instead of the manufacturer with regard to the latter's obligations under this Directive”.

Article 14.2 defines the requirements thus: “Where a manufacturer who places a device on the market under his own name does not have a registered place of business in a Member State, he shall designate a single authorised representative in the European Union”. In simple terms this means that overseas manufacturers need to identify an EC authorized representative (EC REP), located in Europe, to undertake certain tasks and responsibilities.

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Posted by on in EU Activities

March 2013 

Time for Change

The Medical Device Directive [1] is clearly getting ‘long-in-the-tooth’.  Product development by the Industry has progressed immeasurably over the last 20 years since its first publication in the EU’s Official Journal to now include technologies such as nanotechnologies, stand-alone software, tissue engineering and micro-electronics to name but four. 

Despite the revision [2] in 2007, the current regulatory scheme is coming under increasing strain, as the CE Mark originally intended for traditional devices such as dressings and implants, struggles to include these new technologies.

At the same time that technology development accelerates, so has the public perception and understanding of medical devices.  The surgeon, nurse and patient have more product related information at his or her fingertips through the Internet, newspapers and published literature, than ever before.

Because of recognition of these misgivings, steps were initiated by the European Commission more than two years ago, to consider what the new iteration of the Medical Device Directive should look like, resulting in the proposal for regulation 2012/0266 (COD), published in September 2012 [3].  Events of 2012 however, particularly the scandal involving PIP breast implants [4] and ‘Metal-on-Metal’ partial hip replacements [5] have accelerated these plans.

But what do these changes include and what do they mean to the Medical Device manufacturer? 

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