EMDT_European Medical Device Technology

European Medical Device Technology, Spring 2014

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24 | Spring 2014 European Medical Device Technology emdt.co.uk regulations and standards N ew clinical data requirements in the European Commission's proposals for the revision of European regulations for medical devices will have an enormous impact on all involved parties—most importantly, patients. This article discusses some of those requirements, including the proposed amendments from the European Parliament. European regulation of medical devices, including in vitro diagnostic (IVD) devices, is undergoing significant revision. On 26 September 2012, the Euro- pean Commission published a proposal for regulation of medical devices 1 and a separate proposed regulation of IVD devices 2 . The proposed regulations are subject to the Euro- pean ordinary legislature procedure, which requires examination and adoption by the European Parliament (EP) and Council of the European Union (Council). On 22 October 2013, the EP voted to accept 347 amendments to the European Commission's proposal for medical devices and 254 amendments for IVD devices 3 . This was not, however, a formal legislative vote; instead, the formal vote was held on 2 April 2014, which resulted in the EP adoption of the text of 22 October 2013. This action closed first reading of the ordinary legislature proce- dure, requiring that the adopted text be forwarded to the Council, the Commission, and national parliaments. EP elections, however, will be held 22 to 25 May 2014, which means that newly elected EP members will need time to familiarize themselves with both proposals. In addition, the Council must com- plete work on its own position on the Commission proposals and EP amendments. Considering the most likely scenario, the proposed regulations probably will not be adopted before late 2015, mean- ing that the new requirements are unlikely to become mandatory before 2018. Clinical Evaluation Article 49, Clinical evaluation of the proposed regulation for medical devices, specifies that clinical evaluations must be conducted in accordance with the principles established in that article of the proposed regulation for medical devices and also with Part A of Annex XIII, Clinical Evaluation and Postmarket Clinical Follow-Up. As in the current Medical Devices Directives, a clini- cal evaluation may be based on a critical evaluation of the scientific literature of equivalent devices, a critical evaluation of the results of clinical investigations, or a critical evaluation of the combined clinical data from both sources. Part A of Annex XIII outlines how to conduct a clinical evaluation, clearly based upon the European guid- ance document on clinical evaluations (MEDDEV 2.7.1 Rev. 3). The European Commission's proposal is consistent with clinical evalua- tion requirements in the MDD and AIMDD. This proposal would allow manufacturers to argue that conformity with the general safety and performance requirements based upon clinical data is not necessary. In this case, they would need to duly justify conformity with the same requirements based upon the results of nonclinical testing methods alone. Such an exemption is usually applicable only for low-risk devices. Unfortunately, the EP has taken issue with this approach, and EP amendment 172 stipulates that this exemption must be subject to prior approval by the competent authority. But the suggestion that prior approval should be given by competent authorities with gener- ally limited resources seems disproportionate, if not unrealistic. Maria E. Donawa How Will Proposed Changes to European Regulation Affect Clinical Data Requirements? Uncertainty looms as a plethora of proposals and amendments threaten to alter the European medical device regulatory landscape. ES430751_EMDT1405_024.pgs 04.29.2014 03:27 UBM black yellow magenta cyan

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