Introduction to dermal fillers
Dermal fillers are injectable soft tissue substances used in aesthetics to improve skin appearance and minimize wrinkles. Dermal fillers contain naturally occurring substances such as hyaluronic acid, collagen, or other related substances that are part of the connective tissue and extracellular matrix. These substances generally have an extraordinary ability to retain water. Hyaluronic acid, for example, can hold approximately 1.000 times its weight of water, and its injection induces soft tissue augmentation, improve skin hydration, collagen stimulation, and face rejuvenation. As they are naturally occurring in the body, these substances are subject to degradation, and their effect lasts a few months.
Historical classification of dermal fillers
Dermal fillers are commonly used to treat wrinkles. In the United States, these products have been classified as medical devices for decades. In Europe, the dermal fillers have been historically marketed as medical devices, medicinal products, or cosmetics. Due to the US’s stricter regulation compared to Europe, the number of dermal fillers available in Europe was more than 20 times higher than the number of dermal fillers in the US (in 2010). A review of dermal fillers in facial plastic surgery.
Dermal fillers under the MDR
The EU Medical Device Regulation (2017/745) introduces changes to extend the legislation’s scope to aesthetic products without an intended medical purpose but with the same characteristics and risk profile as medical devices.
The dermal fillers achieve their intended use through biophysical properties rather than through pharmaceutical, metabolic, or immunological action; hence their characteristics fall within the definition of medical devices. Additionally, since this device is injected into the human body, the risk profile is high.
According to Annex XVI, paragraph 3, dermal fillers qualify as medical devices:
“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.”
Following Annex VIII, dermal fillers are defined as long-term implantable devices. They are intended to be totally introduced into the human body by clinical intervention and intended to remain in place after the procedure for more than 30 days. Moreover, these devices contain substances that will be wholly or mainly absorbed by the body. Considering these characteristics, the risk class for most of the HA- or collagen-based medical devices would be class III, the highest medical device classification, and the one having to comply with more requirements.
New requirements for dermal fillers
As of May 26, 2021, manufacturers of dermal fillers will have to meet the EU MDR requirements to place and maintain their devices on the market. For manufacturers without previous medical device experience, complying with the MDR might be challenging, especially if their products fall into the class III category.
New requirements for dermal filler medical devices include:
- Partnering with a designated Notified Body to undergo CE Mark certification
- Implementing a quality management system according to the EN ISO 13485:2016 standard
- Appointing a European Authorized Representative if the company does not have a physical presence in Europe
- Obtaining sufficient clinical data to complete a clinical evaluation product following MEDDEV 2.7/1
- Fulfilling the common specifications for dermal fillers (in preparation by the EU commission)
- Providing patients with an implant card according to MDR Annex XVI
- Preparing plans for risk management, post-market surveillance, clinical evaluation…
Manufacturers who fail to meet the MDR requirements by May 26, 2020, can not market their products in the union. For manufacturers with a valid MDD CE mark, a grace period to adapt from MDD to MDR will be provided.
AKRN specializes in CE mark services compliant with the Regulation (EU) 2017/745. As part of our regulatory services, AKRN can assist dermal filler manufacturers in fulfilling the requirements needed to achieve the CE mark under the new MDR. We can also assist the manufacturer with an existing certification to perform a complete transition from MDD or other directives (cosmetic products Regulation (EC) No 1223/2009 and medicinal products REGULATION (EC) No 726/2004) to the new MDR.