The implementation of the EU Medical Device Regulation (MDR) and the EU In-Vitro Diagnostic Regulation (IVDR) is fast approaching, arriving in May 2021 and May 2022 respectively. Medical device and IVD companies face considerable changes to the regulatory framework for their products and need to plan ahead to ensure that they are ready.
These regulations will have a far-reaching impact upon any business seeking to expand into the EU. However, the sheer complexity of the regulations and the volume of continuous new guidance in relation to them creates serious barriers to market entry.
Our Medical Devices team has developed two comprehensive guides to help address this. Each guide provides clarity for medical device and IVD companies who may find the sheer size and complexity of the regulations a substantial hurdle to their international expansion plans.
Latest medical devices news and insights
Life Sciences Legal Lens Vol. 2
A European Perspective #2
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Update: AI-Enabled Medical Devices and IVDs Confirmed as “High-Risk”
Digital Omnibus Update. More time (up to August 2028) yet confirming that AI-enabled medical devices and IVDs stay subject to the AI Act.
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CJEU on distributor's verification obligations under MDR
Medical device (and IVD) distributors. CJEU confirms that distributors need not repeat the manufacturer’s classification or conformity assessment, but must perform a “consistency check” for obvious inconsistencies.
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Landmark CJEU Decision on the Obligations of Medical Device Distributors
CJEU Advocate General on Distributors’ Obligations for Medical Devices
