The products available in pharmacies range from medical devices with a low risk profile such as first aid bandages, syringes, thermometers, rubber condoms, tongue depressors, and examination gloves, to higher risk categories including products such as pregnancy related kits, blood glucose monitoring systems, chlamydia test kits, contraceptive intrauterine devices, ophthalmic irrigation solutions, dressing incorporating an antimicrobial agent, and condoms with spermicides. In addition, pharmacies traditionally prepare so called ‘custom-made’ medical devices according to a prescription to meet needs of individual patients.
Community pharmacies distribute a significant number of medical devices and in vitro medical diagnostic devices. The safe and correct use of medical devices as well as the monitoring of possible safety problems with marketed medical devices are areas where community pharmacists have a view and a role to play.
PGEU broadly welcomes the Regulation on Medical Devices (Regulation (EU) 2017/745) and In Vitro medical Diagnostic Devices (Regulation (EU) 2017/746) which were adopted on 5 April 2017. The reform of the pre-existing legislation responded to recent scandals linked to the certification and control of medical devices which pointed to the need to rebuild patient trust in the robustness of the EU approach. The new rules will apply after a transitional period of 3 years after entry into force for the Regulation on medical devices (spring 2020) and 5 years after entry into force (spring 2022) for the Regulation on in vitro diagnostic medical devices.
PGEU will monitor implementation of Regulations and in particular for the following areas:
- Extent of the surveillance obligations placed on distributors including community pharmacies at national level;
- Establishment of the system of traceability of medical devices and obligations for distributors. PGEU consistently advocated for compatibility of these requirements with those established by the Falsified Medicines Directive;
- The growing tendency for some ‘borderline’ products to be classified as Medical Devices rather than medicines, and the impact of this on pharmacy practice given the surveillance and traceability obligations proposed by the Regulation;