Medical Device Link.

MDT 06 EVENT REVIEW

Look out for tighter controls

Mika Reinikainen, V. P., Quintiles Consulting

The regulatory authorities are “tightening the screw,” said Mika Reinikainen, Vice President, Quintiles Consulting, in his report on the changes to the Medical Device Directive (MDD) delivered at MDT06. The revisions are bringing more requirements and more vigilance. Some changes are radical. For example, provisions for stand-alone software with the new need in Europe for software validation; reclassification of some medical devices, including stricter requirements for Class II products; and in conformity assessment, sample review will become law. Medical device manufacturers will in future be responsible for user errors (when their products are being used for their intended use); thus, when undertaking risk assessment, they will need to give careful consideration to how users may use their products incorrectly. There are also significant changes in clinical evaluation and manufacturers will have to provide improved clinical data in future, a change designed to eliminate the current abuse of the literature route. Although the changes to the MDD are not likely to come into effect until 2009–2010, Notified Bodies (NBs) will be implementing the clinical evaluation provisions before then, said Reinikainen, who also warned that NBs may increase their prices because there is more work to do.

Mike Kreuzer, Director Regulation Priority, ABHI

The 13th annual MDT European Conference, held on 15 February 2006, was chaired by Mike Kreuzer, Director Regulation Priority, the Association of British Healthcare Industries. Speakers gave valuable updates on a range of areas. In addition, a half-day workshop, led by Mark Boult, Principal, DNV Consulting, gave delegates the opportunity to practice using the different risk management techniques for compliance with EN ISO 14971, Risk Management.

Máiréad Finucane, Irish Medicines Board

A peek into Member States activities Máiréad Finucane, Registration and Compliance Coordinator, Irish Medicines Board, provided some insights into the little-known workings of the Member States Operations Group. With a focus on efficient market surveillance and enforcement, and optimising inspection audit procedures for NBs, the Group is developing guidance documents for a number of areas, which are expected to be published by mid to late 2006. These include clarifying the role and responsibilities of Authorised Representatives; technical documentation guidelines for Class I products and custom-made devices; and declaration of conformity guidelines that will clarify the type of information Competent Authorities expect to find. Two other important areas of the Group’s attention is counterfeiting and the Internet market. There were up to four cases of counterfeiting in Ireland in 2005, she said, and one ended in prosecution. Medical device companies are vulnerable to counterfeiting because of the lack of legislation in this area and it is difficult to control imports and exports. Prime candidates are the large-volume, well-distributed brands. Future work of the Group is the development of a European strategy for handling counterfeiting and distribution and traceability of products.

FDA update

FDA is seeking to improve the Center for Devices and Radiological Health’s (CDRH) postmarket surveillance programme, said Ronda Balham, Director of Global Regulatory Affairs, Donawa Consulting Sarl. FDA has recently announced the Medical Device Postmarket Transformation Initiative, she said, which will focus on an electronic reporting system, improved internal collaboration and collaboration with professional organisations and the medical device industry. This follows the transfer of responsibility for postmarket Condition of Approval studies from the Office of Device Evaluation to the Office of Surveillance and Biometrics in an effort to obtain better information about the safety and effectiveness of medical devices in the “real world.”

Participate in tissue engineering regulation

Mike Cox, Danish Medicines Agency

Mike Cox, Senior Device Specialist, the Danish Medicines Agency, outlined the principles of the proposed regulation for tissue engineering in advanced cell therapy medicinal products. Although the principles are generally supported by many Member States, it is recognised that the systems and interpretation of its proposed operation require further debate. This regulatory framework was being taken forward by the Austrian Presidency and will then be continued by the Finnish Presidency. Supporting documents and guidance, for example, on good manufacturing practices, clinical data, risk management and the detailed operation of the Committee of Advanced Therapies are currently being considered. Delegates were advised that the formal review by other Member States and further consultation with interested parties may result in changes to its format and structure. In the meantime all are encouraged to participate in the development of a practical and workable regulation to allow European patients access to the benefits of these innovative products.