Medical Device Regulations in the EU
A major issue impacting the EU medical device sector was the vote by the European Parliament’s Committee on the Environment Public Health and Food Safety (ENVI) in favor of a new stricter regulatory framework. In September 2012, the European Commission adopted a proposal for the regulation of medical devices and in vitro diagnostic medical devices, replacing the existing three directives. The new regulations, which were finally agreed on June 2016, required that certain devices went through a pre-market assessment process by the European Medicines Agency (EMA). They will come into effect during the first semester of 2017 after final approval by the European Council and the European Parliament.
The new regulatory framework will apply to most implantable devices (which will be required to undergo randomized clinical trials), high-risk medical devices (which will have to go through a pre-marketing authorization system), and all in vitro diagnostic medical devices entering the EU market. These changes were in response to a number of medical device failures in recent years, including metal-on-metal hip replacements and breast implants manufactured by the former French company Poly Implant Prothese.
As in most EU regulations, it’s the member states who mostly have the last word on whether or not a product falls within the scope of the regulation itself. It will be them who decide in a case-by-case basis in the event of problematic cases.
Proponents of the new regulations claim that more stringent reforms will improve the quality, efficacy and safety of medical devices in the EU. Others argue that stricter regulations will only result in a loss of the EU’s competitive advantage – medical devices enter the EU market on average three to five years earlier than the US. According to industry experts at medical device group Eucomed, “the proposed regulatory system will not only unnecessarily delay by three years patient access to the latest lifesaving medical technology, but also deliver a devastating financial blow to Europe’s 25,000 small and medium-sized device makers.”
Once again, after the regulation has been finally passed and comes into actual effect, manufacturers and companies operating in this sector trying to enter the European market will face the necessity of localization and translation services. The EU has very strict regulations regarding languages and how products, medicines and other appliances should be presented when sold within its markets. The European Union is composed by 28 member states and has 24 different official languages. Although some countries will allow some of the documents accompanying medical devices or drugs to be written in English in certain cases, most of them require that they will be translated into at least one of their official languages. As European regulations state, information pamphlets or instructions for use should be in a language that the final user understands, no matter if the product is for professional or lay use.
The European Union is one of the biggest, most important markets in the world, so it is only normal that most pharmaceutical companies and medical devices manufacturers wish to place their products there. When tackling the European market, partnering with a professional LSP with expertise in EU regulations is the smartest move. Although machine translation or an internal staff member that is fluent in various languages could seem like an fast, cheap option, EU bodies are strict when it comes to legal issues, and will probably hinder your approaches. A professional LSP will count on a wide network of well-trained translators with expertise in European legislation, terminology and style.
Life sciences translation can be tricky and cost more than money, so don’t trust the process to anyone.
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