[P] [B] Summary of responses to the Consultation[/B] [/P] [P] The Commission Services received, and responded to, over 80 written submissions, resulting in over 300 specific comments, from a variety of stakeholders, but primarily from industry, trade associations, consultants and national authorities; a small number of individuals and patient groups also responded. [/P] [P] Geographically most submissions came from the European Union, with others from Switzerland, USA, Australia and Japan [/P] [P] The most significant areas that attracted comment were: [/P] [P] [B] Clarity and Consistency [/B] [/P] [P] The bulk of the total comments received point to editorial changes that bring clarity and consistency to the text. These helpful comments were taken on in full and will be reflected in the final text. [/P] [P] [B] Classification [/B] [/P] [P] A number of comments related to the changes to the classification rules that result in the reclassification of a number of devices and device types, some questioning the rational for the changes, some calling for an adequate transposition period to allow for the adjustment. [/P] [P] In particular, and receiving the most comment, was the reclassification of reusable surgical instruments. Here, the consistent message from industry was that this reclassification was inconsistent with the risk posed by these devices and that reclassification would have a significant effect on the market. Thus it was decided to consider this reclassification more carefully and not proceed with it as part of the current revision. A reclassification procedure, through Comitology, is available under Article 13 of the Directive.[/P] [P] [B] Clinical Evaluation [/B] [/P] Quite a number of comments sought guidance or interpretation of the text on clinical evaluation. The fact that this text received significant comment was not unexpected as it was the one area of the Directive that was substantially rewritten to reflect the concerns of authorities as to the quality of clinical data and clarify the requirements. [/P] [P] Guidance on clinical evaluation was already foreseen. The Commission services, through its Clinical Evaluation Task Force, comprising Authorities, notified bodies and industry, is currently drafting guidance on clinical evaluation that will assist authorities, notified bodies and manufacturers alike. [/P] [P] The text will also be analysed editorially in light of some of the comments received.[/P] [P] [B] Conformity Assessment [/B] [/P] [P] Comments here centre on the impression that the proposed text has de facto made conformity assessment for class IIb medical devices equivalent to that of class IIa. [/P] [P] Again this will be examined to ensure that this is not the case, and that the difference is maintained.[/P] [P][B] Role of EMEA [/B] [/P] [P] The current text on the assessment of medical devices that contain a medicine with action ancillary to that of the device was updated to take account of the revised directive on medicinal products, Directive 2001/83/EC. Industry is concerned that the role of EMEA, as elaborated in the new text, goes beyond their competence, i.e. might give it a role in the decision of the medical device component. [/P] [P] This will be clarified in consultation with the services responsible for Pharmaceuticals.[/P] [P] Two regulatory aspects, not contained in the original proposed draft, but resulting in significant comment from European trade associations, were the reprocessing of single use devices and the application of the Directive to custom-made devices imported into the EU. Arising from these comments, the Commission services met with the trade associations concerned with a view to examining the possibility to address these aspects in the context of the proposed revision. The following conclusions were made:[/P] [P] [B] Reprocessing of ‘single use’ devices [/B] [/P] The trade federation representing the manufacturer’s of ‘single use’ devices claim that the reprocessors of single use devices should be considered as being included in the definition of ‘manufacturer’ and hence their activities should be regulated under the Directive as, in their opinion, lack of regulation in this field represents a threat to patients safety. For their part, the reprocessors’ trade federation would welcome Community wide regulation of their activities, which are currently the subject of national measures, and have highlighted what is, in their opinion, misuse of the ‘single use’ claim.[/P] [P] The option to include reprocessing of single use devices into the Directive was not chosen. In examining the issue in detail, including bilateral meetings involving the relevant trade federations, it became clear that the issue goes far beyond this Directive and a simple expansion of the definition of ‘manufacturer’, and raises questions that would require further reflection by the Commission services, in consultation with a wider group of stakeholders, to explore possible development of appropriate legislation in this area. [P] [B] Custom-made devices [/B] [/P] EU and national trade associations, particularly in the dental prosthetic field, are calling for measures to greater ensure that the provisions of the Directive, as applied to custom-made devices (dental prostheses, orthopaedic appliances and the like), are applied equally to devices manufactured inside the EU and those imported into the EU from third countries. [P] A number of suggested solutions to the issue were examined for possible inclusion in the proposed draft Directive. These ranged from increased documentary evidence to requiring custom-made device manufacturer’s to undergo assessment by Notified Bodies. Here, in recognition of the Commissions objectives on simplification, options based on transparency were chosen over increased legislative and financial burden on manufacturers and authorities. The solutions chosen are based primarily on inclusion of more evidence of compliance within the ‘statement’ required under Annex VIII.[/P] [P] Following from the consultation, it is expected that a Commission proposal will be submitted to the Council and the Parliament in October of 2005.[/P] [P] The Consultation was based on the following documents:[/P] [P] A text [B] highlighting the changes [/B] as they would appear in the current text of Directive 93/42/EEC.[/P] [P] In line with the [B] Communication [/B] presented to the Council and Parliament in the summer of 2003 the Commission services, together with stakeholders, has prepared an early draft text to amend the Medical Devices Directive 93/42/EEC.[/P]