What is a wound and skin care medical device?
A wound and skin care medical device can be defined as a wound dressing, cotton wool, gauze dressing, bandage, sutures for dermal wound closures (of less than 30 days) and surgical gloves. These devices might also incorporate an antimicrobial agent or utilize animal tissue; please review the European Commission MDCG 2019-14 or the UK MDR 2002, depending on where you are marketing your product, for further guidance on these types of devices.
Where products require additional expertise, we collaborate with our in-house clinicians and technical teams covering all areas from active implantable, dental, orthopaedic and vascular, to medicinal substances, devices utilizing animal tissue and sterile medical devices.
BSI is able to offer CE certification services under the EU MDR and UKCA services under the UK MDR 2002 for wound and skin care medical devices. Examples of products we cover include:
- Adherent (silicone/acrylic adhesive) and non-adherent dressings
- Alginates dressings
- Anti-adhesion products
- Emollients and creams
- Extra cellular matrices
- Films, foams and gels
- Hydrocolloids dressings
- Hydrogel dressings
- Negative pressure wound therapy
- Nonwovens dressings
- Polyurethane dressings
- Bandages, first aid dressings
- Staples and sutures
- Surgical gloves
For more clarity on wound and skin care and related medical devices, please refer to the MDR (EU) 2017/745 and the UK MDR 2002.