As one of the most anticipated pieces of political legislation in recent years, the Brexit agreement that will allow the United Kingdom to withdraw from the European Union will have a tremendous impact on numerous industries. One of these is the medical device industry, which is currently undergoing a number of innovations as well as legal issues concerning lawsuits filed by patients regarding faulty devices. Nevertheless, the industry is one that is expected to continue to grow at a rapid pace in the years ahead, as technology continues to be used to create even more sophisticated devices. Because of this, the Brexit draft agreement may have a number of implications for medical devices.
While the Brexit draft agreement is almost 600 pages long, it has a large area devoted specifically to the medical device industry. Within the agreement are five regulations and directives aimed at medical devices, and even though this is still a draft agreement, most experts believe these same regulations and directives will still be in place when the final version is approved.
Council Directive 93/42/EEC
This first directive, which many familiar with the Brexit draft agreement consider to be the most important of the five regulations and directives, focuses on consolidating and simplifying laws related to medical devices within the European Union. With this directive in place when the final Brexit agreement is approved, if a medical device manufacturer wants to introduce a product into the UK, the device will still be required to meet medical directive requirements.
This directive, which deals with in-vitro diagnostic medical devices like HIV and pregnancy tests, also deals primarily with guidelines manufacturers will have to comply with if they wish to introduce their products into the European Union market. In addition, the draft agreement states that all details associated with this directive, such as classifying the definition of an IVD, requirements of the devices, and what accessories can be used with the devices, will still apply to new in-vitro diagnostic medical devices that come after Brexit.
Council Directive 90/385/EEC
Focusing on implantable medical devices, this directive aims to bring together various regulations throughout the European Economic Area. However, its main goal is to allow for the continued free movement of goods within the EU. To accomplish this, a number of safety requirements will be carefully monitored by the agreement, such as material compatibility, user instruction, design documentation, quality management, manufacturer registrations, clinical investigation, and other related areas.
Regulation EU 2017/745
While this regulation deals primarily with amending previous regulations and directives, it also is essential in that it establishes a modern framework for medical devices. In doing so, public health and safety will be closely monitored, as will its impact on market competitiveness. However, this regulation will not come into full effect until 2020, and will place numerous restrictions and reporting requirements on many more substances and materials used to design and manufacture medical devices. In doing so, the goal is to reduce potential risks to consumers that could be posed by more than 2,000 substances.
Regulation EU 2017/746 of the European Parliament
Related directly to the previous regulation, this part of the Brexit draft agreement will also be incorporated in 2020, and will attempt to clarify any issues that may arise regarding public health and safety requirements of medical devices.
Needless to say, there is still much to be debated among those involved with the Brexit draft agreement. However, it does appear clear that whatever results in the final agreement, medical devices will be closely monitored for quality and safety.
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