Following highly publicised events involving medical devices, such as the PIP breast implants scandal and problems surrounding certain hip implants, public attention focused on the safety management of medical devices. As a result, changes have been proposed to the way in which medical devices are regulated in the EU. Agreement on the changes is now close and they could come into effect by June 2016.
MDIs and DPIs are currently Class I devices but, under proposed new classification rules, they may be classified as Class IIa or IIb devices, a change which could have major consequences for inhaler manufacturers.
The classification change is contained in proposals from the European Council:
Annex VII 6.1 Rule 22
‘All invasive devices with respect to body orifices, other than surgically invasive devices, which are intended to administer medicinal products by inhalation are in class IIa, unless their mode of action has an essential impact on the efficacy and safety of the administered medicinal product and those that are intended to treat life threatening conditions, in which case they are in class IIb.’
As Class I devices, inhalers can be self-certified for CE marking. The up-classification to Class IIa or IIb will mean that the device documentation will be subject to review by a Notified Body. This scrutiny will be more rigorous than in the past due to changes in the terms under which Notified Bodies operate. In addition, Notified Bodies are now required to undertake unannounced audits at least once every three years.
The new Medical Device Regulations will also impact many other areas, resulting in a greater emphasis on clinical investigations, the requirement to appoint a ‘Qualified Person’ who has knowledge of device regulation or QMS, and more post-market surveillance.
It will be interesting to see what form the changes take when they are finally agreed. This article is only a brief summary of the proposed changes so if you would like to know more in the meantime or discuss the implications, we would be pleased to hear from you.