Aesthetic companies experience major delays in new CE certificates

The Medicines & Healthcare products Regulatory Agency (MHRA) has noted that many CE certificates are expiring or are due to expire in the next year and has implemented a facility to extend certificates.

The body has published new guidance on the registration of certain medical devices, including dermal fillers and threads. These outline a revised timeline which provides those with expiring CE certificates an extension from the original date of May 27, 2024.

In March 2023, the EU revised the EU Medical Device Regulation (MDR) transitional agreements to extend the validity of the EU Medical Device Directive CE certificates in limited circumstances for certain medical devices.

Aesthetics contacted an MHRA source, who noted that a majority of dermal fillers, threads, and laser and light devices have CE/EC certification as medical devices and therefore companies must ensure their products are registered with MHRA.

These include any therapeutic device relying on electrical energy or source of power (lasers, LED) as well as a medical device intended to be totally or partially introduced, surgically or medically into the human body (dermal fillers, threads). Most non-electrical devices or accessories which bear a CE mark, such as skin peeling products, sterile single use laser heads, cannulas, needles and microblading blades, will also need to be registered with the MHRA.

There is currently one other type of product used in the aesthetics field which can have a CE mark – PPE products.

The MHRA warns companies need to apply for their CE extension as soon as possible to ensure they can legally sell their products in the UK. According to the MHRA, the queue for the new 2017/745 or UKCA certificates is between two to three years.

The validity of certificates has been extended to:

• December 31, 2027 for higher risk devices (class III and class IIb implantable devices except certain devices for which the EU MDR provides exemptions, such as screws and sutures). Includes systems and procedure packs that contain such class III and class IIb implantable devices, like dermal fillers, threads.
• December 31, 2028 for medium and lower risk devices. Includes system and procedure packs that contain such devices and do not contain class III and IIb implantable devices.

To extend their current certificate, companies can head to the MHRA website and fill out the relevant form. The MHRA encourages companies to contact them directly for any questions or further assistance.

The MHRA will be present at the Aesthetics Member and Exhibitor lounge at CCR on October 19-20 to support companies and educate practitioners about device compliance. To get in touch with the MHRA directly, contact them here.