CE Marking vs. SCPN: Why It Matters for Aesthetic Practitioners 

The aesthetics industry is growing at pace, with new products entering the market almost daily. While innovation is exciting, it’s never been more important to understand the regulatory framework behind these products—especially the difference between CE marking, registration, and the role of the MHRA (Medicines and Healthcare products Regulatory Agency). These aren’t just technical details; they directly impact safety, compliance, and patient outcomes. 

Why CE Marking Matters

CE marking is a certification that shows a product meets the health, safety, and environmental standards required in the European Economic Area (EEA). For products used in Great Britan, a UKCA mark may be used instead. For medical devices, CE (or UKCA) marking is essential because it confirms: 

• Rigorous safety testing has been undertaken to ensure compliance completed. 

• The product complies with EU directives for medical use. 

• It is legally registered as a medical device. 

Examples of CE-marked products include Vitaran and Seventy Hyal, both widely used in aesthetic treatments. These products have undergone strict testing to ensure they are safe for injection and meet all regulatory requirements. 

If a product does not carry a CE (or UKCA) mark, it cannot be considered a medical device. Instead, it may fall under a different category—such as a cosmetic product registered under SCPN. 

What Is SCPN and What Counts as a Cosmetic? 

Injecting a product that is not CE-marked as a medical device introduces serious risks: 

• Off-Label Use 
  Using a cosmetic product in a way not specified in its IFUs—such as injecting—constitutes off-label use, which can lead to unpredictable outcomes. 

• Insurance Coverage 
  Many professional indemnity policies exclude coverage for off-label procedures. If complications arise, practitioners may be personally liable. 

• Patient Safety 
  Without CE (or UKCA) marking, there is no guarantee the product meets the stringent quality, efficacy and safety standards required for injection. This increases the risk of: 

1. Adverse Reaction
2. Infection
3. Long-term complications

Even if microneedling is allowed, the product remains a cosmetic—not a injectable medical device. 

MHRA’s Role in Regulation

The MHRA is the UK’s regulatory authority for medicines and medical devices. It ensures that medical devices meet strict safety, quality and efficacy standards before they can be marketed. According to MHRA guidance: 

• Medical devices must be registered with the MHRA and carry CE marking (or UKCA marking for Great Britain). 

• Cosmetics are regulated under separate legislation and registered via SCPN. 

• Classification depends on intended purpose and mode of action. If a product’s action is achieved by physical or pharmacological means it may be a medical device. If it’s for aesthetic purposes only and applied topically, it’s a cosmetic.  

The MHRA also provides advice on borderline products—those that could be mistaken for medical devices or medicines. This guidance helps practitioners avoid misclassification and legal risk. 

The Risks of Injecting Non-CE (or UKCA) Marked Products 

Injecting a product that is not CE-marked as a medical device introduces serious risks: 

• Off-Label Use 
  Using a cosmetic product in a way not specified in its IFUs—such as injecting—constitutes off-label use, which can lead to unpredictable outcomes. 

• Insurance Coverage 
  Many professional indemnity policies exclude coverage for off-label procedures. If complications arise, practitioners may be personally liable. 

• Patient Safety 
  Without CE (or UKCA) marking, there is no guarantee the product meets the stringent quality, efficacy and safety standards required for injection. This increases the risk of: 

• Adverse reactions 

• Infection 

• Long-term complications 

Medical Devices vs. Cosmetics: Both Can Be Effective 

Both medical devices and cosmetic products can deliver excellent results when used correctly. The key is compliance: 

• Follow IFUs: Always adhere to the manufacturer’s instructions. 

• Check the Box: Look for CE (or UKCA) marking if the product is intended for injection or other medical use. 

• Speak to Your Insurer: Confirm that your planned use of the product is covered under your policy. 

• Refer to MHRA Guidance: Ensure your products meet UK regulatory requirements. 

Frequently Asked Questions

Q1: Can I inject a cosmetic product registered under SCPN? 
No. Cosmetics are intended for topical use only. Injecting them is considered off-label and carries significant risks. 

Q2: What does CE marking guarantee? 
CE marking confirms that the product meets EU safety, health, and environmental standards and is legally classified as a medical device. 

Q3: Is microneedling allowed with cosmetics? 
Yes, if the IFUs specify that microneedling is permitted. However, this does not make the product a medical device. 

Q4: What are examples of CE-marked products? 
Products like Vitaran and Seventy Hyal are CE-marked and approved for injection under their IFUs. 

Q5: What should I do before introducing a new product? 
Check for CE marking, review the IFUs, confirm coverage with your insurer, and refer to MHRA guidance. 

To Conclude

The aesthetics industry offers incredible opportunities for innovation and patient care, but safety and compliance must come first. Understanding the difference between CE (or UKCA)-marked medical devices and SCPN-registered cosmetics—and following MHRA guidance—is essential for protecting your patients, your practice, and your professional reputation. 

When in doubt: 

• Check the box 

• Read the IFUs 

• Consult your insurer 

• Follow MHRA standards 

These small steps can make a big difference.