Welcome back to a new appointment with the news on the Dispotech, your disposable excellence blog. Today we will address a topic of the utmost importance, using an article published on medicaldevice-network.com. The subject is Brexit and medical devices.
Unless sensational changes take place, the United Kingdom will officially withdraw from the European Union on March 29, 2019. This is a move that has disrupted the economic, financial and social stability of the old continent. While the work of the British government and Europe continues relentlessly (between setbacks and concern over the GDP), the UK government has recently released a draft agreement regarding future relations between the country and the EU, as well as numerous sections devoted to the future of several industries and multinationals with branches in the United Kingdom. Manufacturers of medical devices are obviously included amongst these. What does the future hold for those companies? Let’s find out together.
The paragraphs devoted to medical devices consist of 5 directives and regulations that must be complied with by the medical device industry starting from the beginning of Brexit.
Council Directive 93/42/EEC
This directive aims to harmonise the laws relating to medical devices within the European Union.
Having this directive in place after Brexit means that in order for a manufacturer to legally place a medical device on the British market the product must be suitable and the guidelines of the current directive must be met.
Directive 98/79/EC of the European Parliament on in vitro diagnostic medical devices
In vitro diagnostic medical devices (IVD), such as pregnancy tests or HIV tests, are subject to this directive if manufacturers want to place them on the EU market. The directive governs aspects such as IVD classification, which accessories can be used with them and other essential device requirements.
Council Directive 90/385/EEC on implantable medical devices
This directive applies to implantable medical devices. Its primary objective is to harmonise regulation in the European economic area and simultaneously allow goods to move freely within the Union. The directive establishes the essential safety conditions with regard to functions, sterilisation, compatibility of materials, user instructions, design documentation, CE marking, clinical investigations, manufacturer registration, et cetera.
EU Regulation 2017/745 of the European Parliament, Directive 2001/83/EC, Regulation 178/2002 and 1223/2009, Council Directive 90/385/EEC and 93/42/EEC6
This directive establishes a regulatory framework for medical devices which aims to safeguard public health and safety by promoting market competitiveness. It will enter into force in 2020, imposing restrictions on the materials used in the design and manufacturing processes of medical devices. The objective is to reduce potential risks related to approximately 2000 substances.
Regulation 2017/746, Directive 98/79/EC and Commission Decision 2010/227/EU1
This regulation is similar to the previous one and regards the new public health and safety laws on medical devices that will be introduced starting in 2020.
What do you think of the effects of Brexit on the medical device industry? Let us hear your opinion by contacting the Dispotech team, your disposable excellence.