Changes brought on by the recently adopted Medical Device Regulation, Regulation 2017/745, have been a cause of concern for some manufacturers of products used within the medical industry. Introduced on 5th April 2017, the new medical device regulation widened the scope of what can be classed as a ‘medical device’, leaving many manufacturers questioning what implications this has for their products or devices and how this will affect the compliance process.
The regulation, in an effort to reshape and improve essential health and safety practices and guidelines, has widened the scope of what we understand to be a medical device to include so-called ‘aesthetic products/devices’. Aesthetic products or devices are defined as any product or device “without an intended medical purpose” but that is still used in the same manner as or has similar characteristics/risks to use as a medical device already under the scope of the previous regulation.
The main consequences this will have for manufactures of aesthetic products is that any product affected by the new regulation will need to be brought into full compliance with MDR 2017/745, including adding (unless already installed) the required standard of notification and post-market surveillance practices.The changes introduced were designed to ensure a higher level of safety for the consumer and a higher level of transparency and harmonization with EU practices for manufacturers.
The regulation will ensure that devices, of all kinds, will live up to their claims and are suitable for their intended purpose under regular conditions of use without compromising the safety of the user. Some examples of devices that will be affected by the regulation include:
- Contact lenses,
- Products intended to be introduced into the human body through surgically invasive means,
- Facial dermal fillers,
- Equipment for liposuction,
- Lasers for skin resurfacing, tattoo or hair removal,
- Equipment for electromagnetic brain stimulation,
- Products or cleaning or sterilizing devices used in a medical capacity.
Other additions in 2017/745 which will affect manufacturers include the requirement for products to be submitted to the EUDAMED database, a Europe-wide bank of information on all medical devices on the EU Market, and the introduction of a Unique Device Identification (UDI) system dictating that UDIs must be attached to the packaging of each product or device. It also calls for manufacturers to set up satisfactory incident reporting, risk management, and customer complaint processes to ensure best practices for post-market surveillance are upheld.
Manufacturers will have until 2020 to bring all their products and devices that fall under the scope of 2017/745 into compliance with the regulation, which leaves plenty of time to upgrade compliance processes, compile the necessary Clinical Evaluation Reports and begin the notification process.
To find out more about what implications 2017/745 may have for your medical device or aesthetic product, to talk to our team of European regulatory and compliance experts, or to get a quote about any of our services, contact us today!