News Special: Medical Device Regulations

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As the end of 2019 approaches, we edge closer to the enforcement of the new EU Medical Devices Regulations (MDR). But, after speaking with those in the specialty, it is apparent that many do not feel ready for the changes or feel adequately informed about how it is going to affect the industry going forward.
Aesthetic practitioner Dr Beatriz Molina reiterates, “We know that the industry is in need of regulation and anything that is going to support this is a good thing. In my opinion, the changes haven’t been communicated as effectively as they could be and there is still some confusion within the specialty.”
The EU MDR 2017/745 was implemented on May 25 2017 and marked the beginning of a three-year transition period. Therefore, the MDR will fully apply from May 26 2020.1 The MHRA states that the changes aim to modernise the current system to ensure better protection of public health and…

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