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Medical Device Standards FDA vs EU

Products that are in different markets need to comply with local health authority or notified body regulations or guidance. While countries are slowly harmonizing to achieve common standards goals, a large gap still exists complicating the process for manufacturers and increasing compliance costs as well

Medical Device Standards FDA vs EU

As on May 2020, EU Harmonized Standards: 79

As on Dec 2019, FDA's List of Standards: 1354

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