Is EU MDR 2020 the Brexit of the Med Dev industry?
Who will MDR affect?
Put forward by the European Union, MDR affects the European Single Market (ESM). The ESM comprises 28 Member States of the European Union, as well as the European Economic Area (Iceland, Liechtenstein, and Norway), as well as Switzerland and Turkey (through bi-lateral agreements). These countries all share the world's largest single market with over 500 million consumers. Member State or non-Member State of the EU, all of these countries will need to comply with the new Medical Device Regulations if they wish to continue industry trade within Europe.
The task of getting and staying compliant is sizeable as it is, and MDR's new, stricter requirements are even stretching the limits of large enterprises. With more stringent requirements for clinical assessments and testing, technical documentation (TD), Notified Bodies (NB), and data sharing under EUDAMED, MDR 2020 will be a turning point for many companies. If unable to meet the requirements in time, or unable to remain compliant after the transition date, many companies risk folding and potentially going out of business. Having a strategy and compliance plan is crucial.
Intertek Inform, and i2i - the innovative digital Standards platform - can be your trusted compliance partner in this transition. Not only can it assist your organisation in being MDR ready in time, it assists in meeting the on going requirements to remain compliant.
Intertek Inform's centralised Standards management platform means that you have control over accessing the Standards and documents and can be certain they are always the current versions. i2i also offers real-time notifications of changes to make sure you're always up to date.
The Next Deadlines
Much like Brexit, it has been a long and drawn out process to get things in order.
The 26 May 2020 is the application date of MDR. This is when all the new regulations laid out come into effect. In theory, all medical devices companies and manufacturers will be able to adopt the new EU MDR.
However, it will take European authorities several years for new registration and reporting procedures to be put into place, therefore transitional arrangements will be used in the interim, elongating the process.
Intertek Inform a will help you seamlessly navigate through the disruptive transition with confidence. It pays to be prepared.
The next deadline is 27 May 2024, which is when the 'grace period' of MDR will end, and all previous Medical Device Directives (MDD) and Active Implantable Medical Device Directives (AIMDD) will become void.
Towards a healthier future
Just as Brexit has had all hands on-deck to resolve the issue, all the best and brightest compliance experts are working on MDR, marking a turning point in the Medical Devices industry to create a better and safer industry for European citizens.
With MDR being the new normal of the Medical Devices industry, Intertek Inform's expertise of more than 100 years in the Standards industry will help guide your organisation through MDR changes.
It's important to remember that compliance within the industry means much more than just ticking boxes and checking items off lists. It often means the crucial difference between life and death for the end consumer.
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8 Benefits of Standards
Compliance with Standards has a range of benefits
Standards can affect an organisation's quality, lead-time, supply chain management and costs. They make trade across international borders easier and promote global competition, having a positive impact on economies.
Medical devices Application of risk management to medical devices
Medical device standards are vital, ensuring safety, quality, and global compliance. They provide a framework for innovation and interoperability, instilling confidence among stakeholders and prioritizing patient welfare in a dynamic industry.