Representatives from the Medicines and Healthcare product Regulatory Agency (MHRA) will be visiting CCR 2019 on October 10 and 11 and ACE 2020 on March 13 and 14.
Medical device compliance officers will attend the leading aesthetic conferences and exhibitions to offer advice and guidance to manufacturers and distributors selling medical devices, as well as to ensure exhibitors are compliant with the MHRA regulations.
If any exhibitors are found not to be compliant or are operating illegally, for example are promoting products with fake CE/EC certificates, then products will be seized by the compliance officers.
Jenny Claridge, commercial director at Aesthetics, said, “In today’s largely unregulated aesthetic market, it is so important that we do as much as we can to promote best practice and educate the industry on regulations that are in place. After the positive presence of the MHRA at ACE 2019, we wanted to invite representatives back to our next events, CCR 2019 and ACE 2020, to do as much as we can to ensure all our exhibitors are promoting their products within the law and adhering to regulations.”
She continued, “The MHRA representatives will also be on hand to offer valuable advice on the new medical device regulations that are due to come into force in May 2020, so we encourage both exhibitors and delegates to ask questions and get updated on how this will affect them and steps that need to be taken to become compliant.”
The new regulations will mean that certain groups of products will have to comply with the Regulation for Medical Devices. These comprise devices for which a manufacturer claims are only used for an aesthetic or another non-medical purpose, but are similar to medical devices in terms of functioning and risk profile. Aesthetic products that will be affected include dermal fillers, body contouring equipment and light-based devices.
According to the MHRA, the change aims to modernise the current system to ensure better protection of public health and patient safety.
A spokesperson stated, “We would advise you to familiarise yourself with the new EU Medical Devices Regulation 2017/745 (MDR) and the in vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR) as they will fully apply in the UK from the 26 May 2020 and 26 May 2022, respectively. The regulations introduce extensive changes, which you can read about in our guidance. These changes will affect manufacturers, importers, distributors, authorised representatives, as well as health institutions.”
To register for CCR on October 10 and 11, click here.
To register your interest for ACE on March 13 and 14, click here.