The Medical and Health care products Regulatory Agency MHRA published an update on the UK.Gov website at the end of December 2020 ( https://www.gov.uk/government/publications/in-house- manufacture-of-medical-devices/in-house-manufacture-of-medical-devices ) concerning in-house manufacture of medical devices and exemptions from the Medical Devices Regulations (MDR). There has been some discussion as to what, if any, exemptions are applicable for prosthetics and orthotics.
There is a line in the text of the update that reads: These regulations don’t apply if your device is only being used for patients within the institute it was made, even if the product is made in one part of a healthcare establishment. For example, if it is made in an NHS Trust laboratory and moved to another part of the hospital, as this means you are not placing it on the market (GOV.UK, 2020).
BAPO have been in direct discussion with the MHRA to clarify if this meant the exemption only applied whilst the patient wearing the device was on the premises of the healthcare establishment and not when the patient had left the establishment. i.e. only whilst they were an in-patient and once they were discharged to out-patient care the exemption ceased.
The answer we got was concise and unambiguous: “We can confirm that the in house exemption for medical devices manufactured by in-house units and supplied to patients within the same healthcare institutions applies to both in-patients and out-patients.” Once devices are placed on the market or transferred to another establishment (a transfer refers to a sale, loan, hire, lease, gift, or any other type of legal transfer), the exemption no longer applies. Should the patient move to another healthcare establishment, the onus for taking on responsibility of the second-hand device is on the receiving establishment. The receiving establishment would need assurance that the product was manufactured to the appropriate requirements. The original manufacturer will have the records in place to show that the product was manufactured to the appropriate requirements. In–House manufacturing units should have a quality manufacturing system in place regardless of this exemption.
This exemption does NOT mean that these in-house units should not have a Quality Management System in place. For patient safety, they should be closely aligned with the MDR regulations, e.g. technical data provided, device types, process systems, traceability records, CE component batch/lot number recorded etc.
If further information is required BAPO recommends departments contact the MHRA direct. Contact details for queries specific to medical devices devices.regulatory@mhra.gov.uk and for general enquiries info@mhra.gov.uk
Reference
GOV.UK. (2020, December 31). In-house manufacture of medical devices in Great Britain. Retrieved February 2, 2021, from http://www.gov.uk: https://www.gov.uk/government/publications/in-house-manufacture-of-medical-devices/in-house-manufacture-of-medical-devices
