Lexxion, a legal publisher, hosts Revising Medical Devices Regulation: The Legal Challenges on January 29, 2013. im
The European Commissions proposals for the long-awaited revision of the European regulatory framework for medical devices were published on September 26, 2012. The recast will not only result in a major overhaul of the present European legal framework but will also produce new legal challenges for supervisory authorities, since the new regime will apply directly in all EU Member States, without a need for national implementation. Data protection and privacy issues are likely to be of paramount importance if stricter rules on tracing and recall are to be introduced. The rules on supervision of clinical evaluation, safety and performance are a prime target for revision, leading to new onerous regulatory tasks for national inspectorates and/or supervisory bodies and tougher new requirements for the medical devices industry. Last but by no means least, as governments reign in public spending in general and health care spending in particular, different techniques can be employed to ensure value for money, including centralized procurement procedures, efficacy assessments as well as pricing and profit controls.