Wound and Skin Care Medical Devices

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
• Gauze
• 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.

Our team has a broad range of experience, including product design and development, manufacturing, sterilization, and product testing.

Our wound and skin care technical specialists are product experts who understand the specifics of these complex medical devices. The team has an average of over 15 years’ industry and regulatory experience. We are highly trained in working with wound and skin care device manufacturers who specialize in a variety of fields, including acute, chronic and infected wounds, burns, dermatology, ostomy, surgical intervention, trauma and wound closure.

In addition, we can provide guidance on wound and skin care combination products that incorporate medicinal components, ranging from known medicinal substances, such as iodine, PHMB and silver, to more complex and borderline medicinal substances. We have a proven track record of successful consultations with many competent authorities and the European Medicines Agency (EMA).

BSI The Netherlands (2797) is a leading Notified Body; we review medical devices to ensure that they conform to the requirements of the European Directives and Regulations. BSI UK (0086) is a UK Approved Body able to provide conformity assessments under the new UKCA scheme. It is critical to work with an EU notified body or UK approved body that understands the industry and has the experience to review and confirm your product’s readiness for market – efficiently, reliably and promptly.

The process of CE or UKCA marking a wound and skin care medical device requires that you, as a manufacturer, fully understand the requirements applicable to your device and have clear, compliant and complete documentation. We have developed MDR Best Practices Guidelines to assist with this.