Brexit Draft Agreement: What It Means for the Medical Device Industry
The Brexit draft agreement sets the stage for how the United Kingdom will withdraw from the European Union, including the impact on industries like medical devices. Understanding this agreement is crucial for manufacturers, distributors, and stakeholders who want to ensure smooth operations during and after Brexit.
The UK government’s draft withdrawal documents include 585 pages detailing the terms of the UK-EU separation, along with a political declaration outlining the future relationship. For the medical device industry, this means the positioning and distribution of devices may continue without major disruption on both sides of the English Channel—if the draft agreement is implemented as planned.
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Key Points of the Brexit Draft Agreement for Medical Devices
The Brexit draft agreement specifically addresses five major regulations and directives in the medical device sector. Here’s a breakdown of what they mean for your business:
1. Medical Device Directive (93/42/EEC)
The Medical Device Directive (MDD) 93/42/EEC harmonizes medical device laws across the EU. After Brexit, this directive will still apply in the UK. Manufacturers seeking to sell medical devices in the UK must continue to meet these established requirements, ensuring compliance with essential safety and performance standards.
2. In Vitro Diagnostic Directive (98/79/EC)
This directive covers in vitro diagnostic medical devices (IVDs), such as HIV tests and pregnancy kits. The draft agreement ensures that IVD regulations remain applicable post-Brexit. This includes classification rules, essential requirements, and permitted accessories for devices marketed in the UK and EU.
3. Active Implantable Medical Devices Directive (90/385/EEC)
The Active Implantable Medical Devices Directive governs devices like pacemakers and cochlear implants. Its main goal is to align regulatory requirements across the European Economic Area (EEA) while facilitating free movement of these products. Key requirements include:
- Safety and performance
- Sterility and material compliance
- CE marking and type approval
- Clinical investigation and quality management
4. Medical Device Regulation (EU) 2017/745
The MDR 2017/745 is designed to safeguard public health while maintaining market competitiveness. Set to fully come into force in 2020, it introduces stricter reporting requirements and limits on materials used in medical devices. Manufacturers must minimize risks associated with over 2,000 substances in device production.
5. In Vitro Diagnostic Regulation (EU) 2017/746
Similar to MDR, the IVDR 2017/746 sets new safety and performance rules for in vitro diagnostic devices. Coming into effect in 2020, it ensures enhanced public health protection while continuing to allow smooth trade in the UK and EU markets.
CE Marking and Brexit: What Manufacturers Need to Know
For medical device manufacturers, the Brexit draft agreement ensures continuity in the CE marking process. CE marking remains mandatory for medical devices and IVDs sold in the UK and EU. Operon Strategist can help you prepare a comprehensive technical file containing all product details necessary for CE certification, ensuring your devices stay market-ready post-Brexit.
Secure Your Medical Device Compliance Post-Brexit Today!
How Operon Strategist Supports Businesses Post-Brexit
Navigating the changes brought by the Brexit draft agreement can be complex. Operon Strategist provides expert guidance for medical device manufacturers to:
- Maintain compliance with EU and UK regulations
- Prepare CE marking documentation
- Understand the implications of MDR and IVDR
- Ensure smooth market entry for new and existing devices
Our team helps you stay ahead in regulatory compliance, minimizing business disruption and safeguarding patient safety.
FAQs
What is the Brexit draft agreement for medical devices?
The Brexit draft agreement outlines the UK’s withdrawal from the EU and specifies how medical device regulations, CE marking, and trade rules will continue to apply post-Brexit, ensuring minimal disruption for manufacturers.
Will CE marking still be valid after Brexit?
Yes. Under the Brexit draft agreement, CE marking remains mandatory for medical devices and IVDs sold in both the UK and EU. Manufacturers must continue to comply with EU and UK requirements.
How does the Brexit draft agreement affect IVDs?
In vitro diagnostic devices (IVDs) remain subject to EU directives 98/79/EC and the IVDR 2017/746. The agreement ensures that new and existing IVDs meet the same safety, performance, and classification requirements post-Brexit.
What are the key directives and regulations impacted?
The agreement maintains compliance with:
MDD 93/42/EEC (Medical Devices Directive)
AIMDD 90/385/EEC (Active Implantable Medical Devices Directive)
IVDD 98/79/EC (In Vitro Diagnostic Devices Directive)
MDR 2017/745 (Medical Device Regulation)
IVDR 2017/746 (In Vitro Diagnostic Regulation)
How can Operon Strategist help with Brexit compliance?
Operon Strategist guides medical device manufacturers through regulatory changes in the Brexit draft agreement, CE marking processes, technical file preparation, and ongoing compliance to ensure smooth market access in the UK and EU.
