The UK government has allowed Brexit draft agreement concerning the withdrawal of the UK from the European Union along with a connection statement and outline of a political statement on the future association between the UK and the EU. This means that the positioning on the market of medical devices may continue undisturbed on both sides of the English Channel.
The draft withdrawal papers consist of 585 pages and hold many sections detailing what will happen to acknowledged industries should this document be officially agreed as the Brexit deal. This progress begins on March 29, 2019, and closes on December 31, 2020.
Brexit draft agreement for medical devices
The segment covering medical devices consists of five regulations and directives that will be in place for the medical device industry in the circumstance of this deal.
However, what do every one of the regulations and directives really mean? The following is a summary of each bullet point in the medical devices category and a signal of what the Brexit draft agreement means for medical devices. The document recommends that all of the following will still be as it is after Brexit has occurred:
Committee Directive 93/42/EEC of 14 June 1993 concerning medical devices
This directive indicates to harmonise the laws relating to medical devices within the EU. Having this directive set up after Brexit will imply that if a manufacturer might want to legally put a medical device on the UK market then it should, in any case, meet the need of the MD Directive.
Committee Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
In vitro diagnostic medical devices (IVDs), such as pregnancy tests and HIV tests, are topics to this directive if any manufacturers need their devices to be accessible in the EU. The directive controls things like what classifies an IVD, what accessories can be used with them and the essential necessity of the devices. The draft agreement specifies that this will still apply to new IVDs after Brexit.
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Committee Directive 90/385/EEC of 20 June 1990 on the estimation of the laws of the Member States relating to active implantable medical devices
This directive applies to active implantable devices. Its first objective is to coordinate the regulatory environment across the European Economic Area while allowing the free movement of goods within the EU. The directive places the required safety requirements in terms of function, sterility, material similarity, marking, user manuals, design paperwork, CE marking, the necessity for type approval, production quality management, clinical investigation and manufacturer enrollment.
Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, change Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC6
This directive initiates a regulatory framework for medical devices that is purposeful to safeguard public health and safety while carrying the competitiveness of the market. It will come fully into force in 2020 and places limitation and reporting requirements on the material used in the design and manufacturing process of medical devices. It focuses to reduce the potential risks posed by around 2,000 substances.
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and reverse Directive 98/79/EC and Commission Decision 2010/227/EU1
This regulation is like the one above and regards the new public health and safety rules on medical devices that will come into power in 2020.
