Traduction de «Projet d'enregistrement des instruments médicaux » (Français → Anglais) :

In addition to overseeing quality assurance in the pre-market, the current provisions and mechanisms comprise both necessary aspects of post-market surveillance, and those most relevant to this bill: implant registration for specific implantable medical devices and requirements for mandatory problem reporting.

Bill S-202 is designed to establish a national and voluntary registry of medical devices that would contain the names and addresses of people who use implantable or prescribed home-use medical devices.

(51) The Commission should adopt the draft regulatory technical standards developed by ESMA regarding the precise characteristics of trade transparency requirements, regarding the monetary, foreign exchange and financial stability policy operations and the types of the certain transactions relevant under this Regulation, regarding the detailed conditions for waivers from pre-trade transparency, regarding deferred post-trade publication arrangements, regarding the obligation to make pre-trade and post-trade data available separately, regarding the criteria for the application of the pre-trade transparency obligations for systematic internalisers, regarding post-trade disclosure by investment ...[+++] firms, regarding the content and frequency of data requests for the provision of information for the purposes of transparency and other calculations, regarding transactions that do not contribute to the price discovery process, regarding the order data to be retained, regarding the content and specifications of transaction reports, regarding the content and specification of financial instrument reference data, regarding the types of contracts which have a direct, substantial and foreseeable effect within the Union and the cases where the trading obligation for derivatives is necessary, regarding the requirements for systems and procedures to ensure that transactions in cleared derivatives are submitted and accepted for clearing, specifying types of indirect clearing service arrangements, regarding derivatives subject to an obligation to trade on organised trading venues, regarding non-discriminatory access to a CCP and to a trading venue, regarding non-discriminatory access to and obligation to licence benchmarks, and concerning the information that the applicant third-country firm should provide to ESMA in its application for registration.

10. Calls for the establishment of the pilot projects proposed, in particular the pilot project aimed at filling in existing data gaps to develop robust evidence-based instruments that reward producers who deliver extra-environmental public goods, the pilot project establishing a European coordinated network for animal welfare, and the pilot project to provide information to consumers, in schools, at points of sale and at other contact points, concerning the high quality, food safety, environmental and animal welf ...[+++]are standards that European farmers have to meet; calls for implementation of the pilot project on the creation of a European farm prices and margins observatory, which, given the price volatility of recent years, will be an important tool for improving transparency in the food supply chain; calls for the extension of the pilot project on an exchange programme for young farmers and for implementation of the pilot project to fine-tune technology for reading sheep’s electronic identification codes; calls on the Commission to implement all the proposed pilot projects.

23. Notes in particular that the Commission plans a review of its general policy on the registration of complaints and relations with complainants in the light of experience of the new methods now being tested; is worried about the Commission's renouncement of the use of the infringement procedure as an essential tool to ensure that Member States apply Union law in a timely and correct way; underlines that this is a duty imposed upon the Commission by the Treaties which cannot be unilaterally renounced; urges the Commission to prove, by means of consis ...[+++]tent data, the declared success of those ‘new methods’ with detailed pre- and post-EU Pilot data and to include in the future regulation principles and conditions for the registration of complaints and any other complainant's rights;

It should draw on a range of measures, such as assistance to third countries to comply with international obligations under the Geneva Convention and other relevant international instruments, to enhance protection capacity, better access to registration and local integration and assistance for improving the local infrastructure and migration management.