The latest on the new medical device regulations and what they will mean for the industry going forward
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 patient safety.
These changes will primarily affect manufacturers, importers, distributors, authorised representatives and health institutions.1 Health institutions are defined as ‘an organisation with the primary purpose of care or treatment of patients or the promotion of public health’.1
The key changes relevant to the aesthetics sector include: raising the threshold for clinical evidence required for the regulation of devices, increasing the requirements placed on notified bodies to ensure they are applying the changes consistently and supporting traceability of devices through Unique Device Identification (UDI), and issuing implant cards to patients.1,2
As well as this, the MDR expands the scope of what is considered to be a medical device. This means that certain groups of products without an intended medical purpose, listed under Annex XVI, will be regulated as medical devices for the first time.1 This includes dermal fillers without any medical purpose, as well as body contouring equipment and light-based devices.1
Additionally, all current medical devices will need to be reassessed for compliance and recertification, which means that companies have had to review the data used to support their products and ensure it meets new requirements.
One of the most significant changes is that dermal filler manufacturers will be required to provide device information and a physical implant card containing: device name, serial number, lot number, the UDI, device model, as well as the name, address and website of the manufacturer, amongst other requirements including life expectancy and warnings.2 Health institutions must also give their patients this physical implant card with their name on it.2
The implant cards should provide information during an emergency, information or safety requirements regarding reciprocal interference, improve patient awareness of warnings/precautions and limitations of normal activity and improve data to implant registries, to identify failed components.2 The aim of this, the MHRA confirms, is to place emphasis on traceability throughout the whole supply chain and provide the patient with information about implanted medical devices, such as dermal fillers and threads, that will make information easily accessible and available.2
Nancy Ghattas, associate vice president, country manager UK and Ireland at global pharmaceutical company Allergan, welcomes the MDR and the changes that it brings, which will affect the company’s dermal filler and body contouring products. She says, “As a responsible company we appreciate any changes that increase the regulatory oversight and transparency of our industry. The purpose of the new MDR is principally to increase the safety of consumers; something which Allergan is very passionate about. We see the changes as a way for the whole industry to become better, to benefit patients.”
Dr Molina shares her view as a practitioner, stating, “Although it’s important that practitioners understand what’s going on in regulatory changes, I don’t think it’s going to have too much of an impact on us as the main focus seems to be on the companies, but within time, this will filter down to clinics and could affect which products and devices we can use.”
Certain groups of products without an intended medical purpose, listed under Annex XVI, will be regulated as medical devices for the first time
Dr Molina believes one of the most notable differences within the MDR are the implant cards. Because of this, she says there is the potential to track and stop any faulty products in the market. Regarding dermal fillers, she also notes that having the ability to know what filler a patient has had could aid in treating and preventing complications.
Dr Molina explains, “I’m very much looking forward to seeing how the implant cards are implemented. I think if we make patients aware of this process then it will also help them to decipher between the good and the not so good practitioners.”
However, she says that for this to work, there needs to be patient awareness of the requirement to receive an implant card following a procedure. “Patients should know that receiving this implant card is a standard, involuntary procedure and anyone that doesn’t issue this may not be as reputable as they say they are,” she explains.
Ghattas echoes this point and believes the implant cards will have a positive impact across the board. She says, “Implant cards will enable customers to have easy access to information on the products they have been treated with. We think it is very important for consumers to be further educated on the products that are being used on them and empowered to ask for more information.”
Whilst Dr Molina recognises that the changes are overall positive, she says it could affect newer companies and products coming to the market. She says, “I think it may be harder for smaller companies and may stop the development of newer products due to the costs associated with additional research and time implications. It’s fantastic that it gives us a guarantee of safety, but I question whether it will limit the progression of the specialty.”
Dr Molina concludes, “My dream is to see all of the top associations collaborate and receive ongoing data from the MHRA regarding reported products. The only way a change is going to come is if we all join forces. I’m hoping that the changes are going to be a step in the right direction and I look forward to seeing a more regulated specialty in time to come.”