Medigarments Ltd

Medigarments Ltd specialises in custom-made compression garments designed for therapeutic and orthotic use. Their product range includes items like forearm sleeves (13–17cm), body suits with adjustable panel configurations (0–4 panels), shorts (53–61cm), chest vests (96–114cm), stump sleeves, lumbosacral support garments (sized for depths over 30cm), open-face masks, panty girdles (both legs above knee with open or closed pubis), and gloves (25–29cm palm length). These devices are tailored to provide compression therapy or support for specific body areas.

Medigarments Ltd is based in the UK, which means its devices are subject to EU regulatory requirements, including registration in the eudamed database. Since all its devices fall under Class I of the EU Medical Device Regulation, they are considered lower risk but still require compliance with EU standards for manufacturing, labeling, and post-market surveillance. The UK’s regulatory alignment with EU frameworks ensures these devices meet necessary safety and performance criteria.

Medigarments Ltd’s devices are listed in the eudamed database, which is the official EU registry for medical devices. This registry is maintained under the EU Medical Device Regulation (MDR) to ensure transparency and traceability of Class I devices, including those manufactured by Medigarments Ltd. Listing in eudamed confirms compliance with EU requirements for device registration.

All of Medigarments Ltd’s devices are classified as Class I under the EU Medical Device Regulation. This classification applies to low-risk devices like compression garments, which pose minimal risk to patients when used as intended. Class I devices still require compliance with EU manufacturing standards, proper labeling, and adherence to post-market surveillance obligations, though they do not require a Notified Body review for conformity assessment.