Keeler Ltd – EU Medical Device Returns Policy
Effective Date: 07/08/2025
1.0 Purpose
This Returns Policy outlines the conditions under which medical devices supplied by Keeler Ltd may be returned, in compliance with the EU Medical Device Regulation (MDR 2017/745), applicable national legislation, and ISO 13485 quality management requirements.
2.0 Scope
This policy applies to all medical devices sold and distributed by Keeler Ltd within the European Union and EEA, whether purchased directly or via authorized distributors.
3.0 General principles
- Due to the regulatory and safety-critical nature of medical devices, returns are strictly controlled.
- Devices that have been used, opened, or are not in their original, sealed packaging generally cannot be returned, except in cases of:
- Defective product
- Device recall
- Shipment error
- Warranty replacement
4.0 Return eligibility
A product is eligible for return only if:
- It is within 30 days of delivery date.
- It is in its original, unopened, undamaged packaging.
- It has been stored according to the manufacturer’s recommended conditions.
- A Return Material Authorisation (RMA) has been issued by Keeler.
- The return does not breach any infection control or patient safety regulations.
5.0 Returns process
5.1 Request authorisation
- Contact shop.eu@keeler.co.uk within two business days of delivery.
- Provide the order number, device name, lot number, and reason for return.
5.2. RMA issuance
- If approved, you will receive an RMA number and shipping instructions.
- Returns without an RMA will not be accepted.
5.3. Shipping the device
- The device must be returned to [Designated Returns Address] in protective packaging.
- The RMA number must be clearly marked on the package.
5.4. Inspection & decision
- Upon receipt, the device will be inspected by Keeler quality personnel.
- Devices that do not meet eligibility criteria will be returned to the sender at their expense.
6.0 Non-returnable items
- Any medical device that has been used or opened.
- Products with broken safety seals or damaged packaging.
- Devices that are custom-made or patient-specific.
- Devices past their expiry date.
- Devices not stored according to instructions for use (IFU).
7.0 Faulty or non-conforming devices
- If a device is found to be defective or non-conforming to specifications, Keeler will arrange for return shipping at no cost to the customer.
- Non-conforming products will be handled in accordance with MDR 2017/745 Article 87 (vigilance reporting) and ISO 13485 requirements.
- Replacement or credit will be issued once investigation is complete.
8.0 Recalls
- In the event of a product recall, Keeler will contact affected customers directly with instructions, in compliance with EU MDR requirements.
9.0 Refunds & credits
- Approved returns will be refunded or credited within 30 business days after inspection.
- Refunds will be issued using the original payment method unless otherwise agreed.
10.0 Contact
- If approved, you will receive an RMA number and shipping instructions.
- Returns without an RMA will not be accepted.
5.3. Shipping the device
- The device must be returned to [Designated Returns Address] in protective packaging.
- The RMA number must be clearly marked on the package.
5.4. Inspection & decision
- Upon receipt, the device will be inspected by Keeler quality personnel.
- Devices that do not meet eligibility criteria will be returned to the sender at their expense.
6.0 Non-returnable items
- Any medical device that has been used or opened.
- Products with broken safety seals or damaged packaging.
- Devices that are custom-made or patient-specific.
- Devices past their expiry date.
- Devices not stored according to instructions for use (IFU).
7.0 Faulty or non-conforming devices
- If a device is found to be defective or non-conforming to specifications, Keeler will arrange for return shipping at no cost to the customer.
- Non-conforming products will be handled in accordance with MDR 2017/745 Article 87 (vigilance reporting) and ISO 13485 requirements.
- Replacement or credit will be issued once investigation is complete.
8.0 Recalls
- In the event of a product recall, Keeler will contact affected customers directly with instructions, in compliance with EU MDR requirements.
9.0 Refunds & credits
- Approved returns will be refunded or credited within 30 business days after inspection.
- Refunds will be issued using the original payment method unless otherwise agreed.
10.0 Contact
- Upon receipt, the device will be inspected by Keeler quality personnel.
- Devices that do not meet eligibility criteria will be returned to the sender at their expense.
6.0 Non-returnable items
- Any medical device that has been used or opened.
- Products with broken safety seals or damaged packaging.
- Devices that are custom-made or patient-specific.
- Devices past their expiry date.
- Devices not stored according to instructions for use (IFU).
7.0 Faulty or non-conforming devices
- If a device is found to be defective or non-conforming to specifications, Keeler will arrange for return shipping at no cost to the customer.
- Non-conforming products will be handled in accordance with MDR 2017/745 Article 87 (vigilance reporting) and ISO 13485 requirements.
- Replacement or credit will be issued once investigation is complete.
8.0 Recalls
- In the event of a product recall, Keeler will contact affected customers directly with instructions, in compliance with EU MDR requirements.
9.0 Refunds & credits
- Approved returns will be refunded or credited within 30 business days after inspection.
- Refunds will be issued using the original payment method unless otherwise agreed.
10.0 Contact
Keeler Ltd
Customer Service – Returns Department
Email: shop.eu@keeler.co.uk
Or complete our online form: https://www.keelerglobal.com/support-and-repairs/repairs/