Aplos Device Regulatory Consulting UK Ltd specializes in aiding small medical device companies in regulatory strategy, including submissions, regulatory compliance, and authorized representation for the European Union (CE Mark).
If you are a small company wanting to market your medical device in the European Union, the process is actually easier than ever before, as companies must comply simply with one set of directives of the European Union rather than each individual country.
*NOTE*: Due to the 2016 United Kingdom European Union membership referendum (i.e. Brexit) and its subsequent withdrawal from the European Union, the UK now has somewhat different guidelines. Please check back for updates, as Aplos will be discussing the regulatory compliance implications of Britain leaving the European Union.
American-based companies looking to sell their products in Europe must have an Authorized Representative (AR) that will act as an intermediary between the company and the competent authorities in the EU (as stipulated by Council Directive 93/42/EEC and amended by Directive 2007/47/EC).
The regulatory approval process often scares and intimidates many companies from going ahead with the process. Unfortunately, many other authorized representatives (AR) often contribute to the problem by making the process sound as complex, cumbersome, and intimidating as possible, charging thousands of dollars in retainer fees on top of very steep hourly rates regardless of how much work they actually do for the client.
We think it's time for a better solution. We keep the process as straightforward for you as possible, at reasonable rates with no pointless retainer fee -- and with powerful results. Aplos has successfully established European & UK regulatory approval (CE Mark) to market tests since 2012.
BREXIT:
Brexit is shorthand for Britain's withdrawal from the European Union.
On 23 June 2016 the United Kingdom and the Island of Gibraltar voted in a referendum to leave the European Union. The UK officially left the EU on 31 January 2020. As such, the CE label no longer applies to goods sold in the UK.
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