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Sid Dajani, the Royal Pharmaceutical Society's elected representative on the Pharmaceutical Group of the European Union, discusses draft EU regulation for medical devices

Medical devices legislation covers a wide range of products, including many that are distributed through pharmacies, for example, asthma inhalers, first aid bandages, syringes, thermometers, condoms, pregnancy-related kits, insulin pens, blood glucose monitoring systems, tongue depressors, examination gloves, etc. In addition, the legislation will cover products such as hip replacement implants, prostheses, x-ray equipment, heart valves, etc.

The current legislation is being strengthened due to recent developments linked to the approval of problem medical devices, such as the issues with breast implants in France and the DePuy hip replacement.

The draft proposal is interesting because it includes obligations for distributors
(including pharmacies), as well as a proposal to trace medical devices. At this point is worth noting that if these obligations on distributors apply to pharmacies the consequences will be burdensome in terms of bureaucracy, resources and workload. It is also important to consider the compatibility of the traceability system introduced by the medical devices legislation and the one proposed in pharma legislation (the Falsified Medicines Directive).

PGEU expressed strong concerns because some obligations will be unworkable for pharmacists and others will require communication practices within the supply chain to be adapted. In addition, the proposal points out the problem of the compatibility of the traceability system proposed for medical devices and the verification process envisaged in the pharma

legislation. If the regulation remains unchanged, pharmacists will be exposed to two different systems of traceability with different technologies and processes of verification: human medicines and medical devices. Such a duality of systems supposes a waste of resources in terms of cost and time, with an ultimate prejudicial impact for patients.

PGEU tabled an amendment exempting pharmacists from the obligation of ensuring that manufacturers have complied with all their traceability obligations, and a second amendment to ensure corrective action undertaken by pharmacists is within the scope of their activities.

The European Parliament voted on its first reading of the draft legislation on April 2, with the object of consolidating the work done so far and handing it over to the next Parliament. This will ensure that the new MEPs elected in May can build on work done during the current term.

PGEU is continually lobbying for support for amendments adopted in the European Parliament and also addressed the problem of the amendment not adopted in the regulation on in vitro diagnostic devices but carried in the medical devices regulation. An outcome is expected early in the new year.