Specific Elements In terms of improving the Notified Body system, EU regulators have suggested in

Specific Elements

In terms of improving the Notified Body system, EU regulators have suggested increased oversight of Notified Bodies via mandating minimum requirements and also more consistent designation and monitoring practices, as well as perhaps implementing EU-level assessors to ensure more uniform standards of conformity assessment are applied by Notified Bodies. The Notified Bodies also are furiously circulating their Notified Body code of conduct document.

Regarding multi-site clinical investigations, EU regulators are proposing designating lead Competent Authorities to handle initial technical assessments, in addition to enhanced engagement of Competent Authority post-marketing safety monitoring, as well as more consistent safety reviews and vigilance assessments. To enhance transparency of the medical device regulatory process, regulators also may provide more public access to some of the medical device information available in the European databank, Eudamed.

Of course, expanding medical device regulations to cover new products and improve processes such as controversial product classification also requires enhanced management and administrative tools. As such, Minor reported that the EU Commission is considering either a group within the European Medicines Agency or the Joint Research Centre as a candidate to serve as a central agency overseeing the new regulations. The idea of introducing a panel of clinical scientific experts and a network of national reference labs was presented.

Other issues that revised EU regulations should address, according to Minor and EC Commissioner John Dalli, who presented at the Eucomed Medtech Forum Oct. 12 in Brussels, Belgium, include reprocessing of single-use devices; regulatory discrepancies between tissue-related products covered by pharmaceutical regulations and EU tissues and cells regulations; and evaluation of nano-materials used in some medical devices.

Furthermore, Dalli said, guidelines developed and published by the Global Harmonization Task Force (GHTF) will inform efforts to revise EU medical device directives. As such, recent GHTF guidance documents on issues such as UDI, IVD classification, and harmonized conformity assessment principles.