Dr. Guido Middeler
Partner
Dermal fillers are injected into wrinkles to minimise their appearance. They contain substances such as hyaluronic acid or collagen, both of which are found naturally in the skin’s connective tissue. Their effect is physical rather than pharmacological, metabolic or immunological. The substances, which are also found in natural connective tissue, bind water, thereby giving the skin more volume and smoothing wrinkles. The body degrades them completely over a period of several months.
Dermal fillers for injection in nasolabial and mentolabial folds, as well as in wrinkles from repeated facial expressions, are commonly used. In the United States, these products have long been classified as medical devices. In Europe, dermal fillers have been marketed as medical devices, medicinal products or cosmetics until now. Over 140 injectable fillers were available in the EU market in 2010. In the US, where the industry is subject to stricter regulation, that number was only six. (Bray / Hopkins / Roberts (2010): "A review of dermal fillers in facial plastic surgery". Current Opinion in Otolaryngology & Head and Neck Surgery, p. 295–302)
The EU’s MDR (2017/745) now expressly classifies dermal fillers, even those without a medical purpose, as medical devices. They are covered by Annex XVI No. 2 MDR: “Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.” Under the classification rules in Annex VIII MDR, they will typically be classified as risk class III, thereby raising the formal requirements for these products – in some cases substantially. For the first time, dermal fillers that have so far not been marketed as medical devices will therefore require CE certification by a neutral notified body.
Manufacturers will need to submit a device master record (technical documentation) and a clinical evaluation of the product in accordance with MEDDEV 2.7/1 to the notified body. Because injectable soft tissue fillers are medical devices “without an intended medical purpose”, they will not require a clinical investigation. However, they will be subject to a clinical evaluation regarding safety “based on relevant data concerning safety, including data from post-market surveillance, PMCF, and, where applicable, specific clinical investigation”.
For starting materials of animal origin, which is often the case in collagen and hyaluronic acid, manufacturers will also need to comply with Regulation (EU) 722/2012.
Last but not least, manufacturers will have to set up and maintain a quality management system in accordance with the requirements of the Medical Devices Directive (ISO 13485).
What is more, the MDR puts pressure on notified bodies, which have to independently provide new notification for specific groups of products before they can conduct the corresponding conformity assessments for the products. In other words, the new MDR will make conformity assessments mandatory for more products. However, fewer notified bodies will be allowed to conduct such conformity assessments – and there are no transitional provisions. Bottlenecks, even leading to marketing stops, are possible.
Manufacturers who fail to meet these requirements will not be allowed to market their products after 26 May 2020. Only those dermal fillers already marketed as medical devices will be subject to a grace period, as current certificates in accordance with the old directive (93/42/EEC) will remain valid for the time being. All other manufacturers will need to address this issue soon to fulfil the wide range of requirements or make sure that a third party is fulfilling them on their behalf.
We help companies that market dermal fillers containing hyaluronic acid, collagen or other related substances adapt to the new MDR. We work with them to develop pragmatic, fast solutions for the new requirements. On request, we can even take over regulatory responsibility for the entire conformity assessment, quality management, marketing and ongoing post-market surveillance (PMS).