Convergence of regulatory procedures is an issue of considerable importance to the medical device and healthcare IT industry.  The medical device industry is moving towards harmonisation of standards.  This aids worldwide trade of medical devices.  This in turn will further reduce the cost of innovative medical technology and improve the quality of healthcare on a global scale.  It is, however, essential that procedures in different regulatory systems be harmonised so that a product is “accepted once, accepted everywhere”.

The use of standards is one way to achieve convergence of regulatory standards.  COCIR actively contributes to the Global Harmonisation Task Force (GHTF).  GHTF is a multinational platform of regulators, government authorities, assessment bodies and industry organisations in the medical devices sector. GHTF’s objective is to harmonise administrative procedures linked to regulatory requirements for medical devices.  COCIR and its partner associations NEMA (USA), JIRA (Japan) and MEDEC (Canada) believe that harmonised procedures will considerably reduce the cost of compliance with regulatory requirements without compromising health and safety of patients and users.

Mutual Recognition Agreement

Another important step towards harmonisation for medical products is the Mutual Recognition Agreement (MRA) negotiated between the EU and third countries.  In the EU non-governmental third parties carry out the conformity assessment and accreditation of medical devices, but in some third countries this is seen as a government responsibility.  COCIR believes that confidence building is an important part of the MRA and that this will contribute to a better understanding of the capabilities of regulatory authorities and conformity assessment bodies. Better understanding will support the discussions in the GHTF process. At the same time, the implementation of MRAs may benefit from the results of the GHTF activities.

COCIR promotes a pragmatic approach in the implementation of MRAs in order to bring the involved parties together in a process of active confidence building. To do so, stakeholder meetings, involving CABs, authorities as well as industry have proven to be valuable as a platform for an open exchange of views and expectations.