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  • With the looming deadlines and constant headlines talking about the coming changes, the parallels between EU MDR 2020 and Brexit are uncanny.

    • They've both been in the works for years (MDR transition started in May 2017).

      They both come with new sets of rules to comply by.

      They both have ripple effects across the entire world, and across multiple industries.

      And most importantly they both mean a massive shift and overhaul in Standards and certifications for the medical devices industry around the world.

      • 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.

        Compliance


        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.

        SAI Global, 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.

        SAI Global'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.

        SAI Global 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, SAI Global'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.

        • MEDICAL DEVICES STANDARDS MANAGEMENT

          RIGID REGULATORY OBLIGATIONS LEAVE NO ROOM FOR ERROR IN THE MEDICAL DEVICES INDUSTRY

        • ISO 14971:2019

          MEDICAL DEVICES - APPLICATION OF RISK MANAGEMENT TO MEDICAL DEVICES

        • 8 BENEFITS OF STANDARDS

          DISCOVER THE BENEFITS TO YOUR BUSINESS

        • Prepare for the EU MDR 2020 transition and beyond. Learn how to reduce risk through efficient quality control.

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