Update for FSRH members: MHRA reporting requirements for contraceptive implants

The FSRH has recently been made aware of queries regarding whether the contraceptive implant is included in the MHRA Medical Device Registry programme and therefore subject to its mandatory reporting requirements. The Medicines and Healthcare products Regulatory Agency (MHRA) states that contraceptive implants do not meet the requirements for the programme, and are instead regulated as a medicine under the Human Medicines Regulations 2012.

Products which are classified as medicines are not included in the Medical Device Registry programme, even though some medicines have a component which is considered to be a device. For a product to be regulated as a medical device under UK Medical Device Regulations 2002, the primary mode of action must not be pharmacologic, immunologic, or metabolic – of which the contraceptive implant is.

All medicines manufacturers are subject to pharmacovigilance requirements concerning their products, such as reporting ‘undesirable reactions’ to MHRA and flagging adverse events or reactions – including in relation to insertion and removal of the contraceptive implant.

Manufacturers are responsible for setting out how they will monitor identified risks and establish any additional measures, which may include a patient alert card and inserter training materials. Occasionally it may be appropriate for a medicine-specific registry to be required to be set up as an additional measure, however, this is not currently needed for sub-dermal contraceptive implants.

We ask that FSRH members share this information with teams, as required or appropriate.