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MDR Compliance
What is EU MDR?
The European Medical Device Regulation (EU MDR) introduces a fresh set of standards governing the production and distribution of medical devices across Europe. Compliance is essential for companies selling their devices in the European market.
Patient Safety and Modernised Standards
The European Union’s updated Medical Device Regulation (MDR), reflected in Regulation (EU) 2023/607 published on March 20, 2023, extends the transition phase for certain medical devices. This allows additional time for manufacturers to comply with stringent new standards, introduced to ensure patient safety and address changes since the original Medical Devices Directive (MDD) of 1992.
Several factors prompted the MDD’s overhaul. When the MDD was introduced, innovations like Software as a Medical Device (SaMD) didn’t exist. Back then, software was primarily used to control electric machinery, and health-monitoring apps for patients were unheard of. Additionally, Europe’s demographics have evolved significantly, with an ageing population that places new demands on healthcare and a greater public expectation for transparency around medical device technical information.
The updated MDR aligns with these realities, promoting consistency across the EU’s medical device regulations. With the recent amendment, manufacturers of class III and certain class IIb devices now have until December 31, 2027, and class IIb, IIa, and class I devices requiring external conformity assessment until December 2028, provided they meet safety and transitional progress criteria. This extension supports safer medical practices and encourages broader compliance with modernised standards across Europe.
UK Market-Specific Regulations and Transition Period
Since leaving the European Union, the UK has opted not to adopt the EU Medical Device Regulation. Instead, the Medicines & Healthcare products Regulatory Agency (MHRA) is developing tailored regulations for the UK market, with key elements of this new regulatory framework set to take effect on July 1, 2025. In the meantime, transitional periods allow certain medical devices with CE marks under EU regulations to remain available on the UK market, subject to specific conditions. For more information, please the UK government website: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
ZOLL’s Commitment to Regulatory Compliance in the EU and UK
ZOLL Medical Corporation’s regulatory team is actively working to ensure a seamless transition of its products’ CE marking from the Medical Devices Directive (MDD) to the Medical Device Regulation (MDR) for the European Union. In 2020, ZOLL received recertification of CE-marked products under the MDD, valid until May 26, 2024, and continues to closely monitor regulatory changes affecting the EU market to maintain compliance. ZOLL devices transitioning to MDR are meeting all necessary conditions to remain available under the extension period through 2027 or 2028, as applicable.
Additionally, ZOLL is closely tracking the development of new UK regulations and taking proactive steps to ensure product availability throughout and beyond the transitional period.
With a strong history of successful product certifications globally, ZOLL was the first company to receive premarket approval from the FDA for its complete defibrillator portfolio in 2018. Building on 40 years of expertise in manufacturing safe medical devices, ZOLL is committed to meeting the new MDR requirements.
Check out our MDR Compliant defibrillators:
More defibrillators we stock are in our shop, also you can email or call us sales@defib4life.co.uk – 01629710128 and find us on social media, on Facebook, Instagram & LinkedIn.