There was NO provision for a period of transition! Amendments to the key EU Medical Device Directives formally took hold on 21st March 2010, with changes that impacted both new medical device developments and medical devices already on the market. Further, under EU regulatory guidance changes to the Essential Requirements and Harmonised Standards also directly impact drug-delivery devices (drug-device combination products) regulated as medicinal products (ref: MEDDEV 2.1/3).
Directive 2007/47/EC amended Directive 93/42/EEC on Medical Devices and Directive 90/385/EEC on Active Implantable Medical Devices with application from 21st March 2010. Changes concern, among others: essential requirements, conformity assessment procedures and classification of devices.
Evidence suggests many in the industry are still confused, with particular uncertainty amongst pharmaceutical manufacturers as to the exact nature of the changes and the impact on their current drug-delivery products and on-going developments.
For devices placed on the market or put into service, compliance with the new requirements is essential. In some cases this includes timely substitution of some of the applicable harmonised standards, like the latest Risk Management standard EN ISO 14971:2009 and the newly harmonised Usability Engineering standard EN IEC 62366:2008.
For renewal of compliance certificates, Notified Bodies must take account of the new evaluation requirements amended by 2007/47/EC, so in many cases manufacturers need to have carried out rework and a relative conformity assessment prior to keep their products on the market legally.
The impact of the legislative changes is in many cases far reaching on manufacturers, although some parts are subtle and phased in their auditable status.
PA understands the impact of these changes in both the medical product and process contexts and can help companies respond to the challenges.
To find out more and for help on addressing these regulatory changes, please contact us now.