Lastly, volunteering and 'voluntourism'. Travel Insurance It goes without saying that you'll need insurance, but it's not something you should be sorting at the last minute as policies vary significantly, start coving you immediately for pre-trip problems and you need to spend a little time reading small print and making sure you don't overpay.
A device shall meet the general safety and performance requirements set out in Annex I which apply to it, taking into account its intended purpose.
Demonstration of conformity with the general safety and performance requirements shall include a clinical evaluation in accordance with Article Devices that are manufactured and used within health institutions shall be considered as having been put into service.
With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the Union, provided that all of the following conditions are met: Member States may require that such health institutions submit to the competent authority any further relevant information about such devices which have been manufactured and used on their territory.
Member States shall retain the right to restrict the manufacture and the use of any specific type of such devices and shall be permitted access to inspect the activities of the health institutions. This paragraph shall not apply to devices that are manufactured on an industrial scale.
In order to ensure the uniform application of Annex I, the Commission may adopt implementing acts to the extent necessary to resolve issues of divergent interpretation and of practical application.
Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 3. Upon request by a competent authority, any natural or legal person offering a device in accordance with paragraph 1 or providing a service in accordance with paragraph 2 shall make available a copy of the EU declaration of conformity of the device concerned.
References in this Regulation to harmonised standards shall be understood as meaning harmonised standards the references of which have been published in the Official Journal of the European Union. References in this Regulation to harmonised standards shall also include the monographs of the European Pharmacopoeia adopted in accordance with the Convention on the Elaboration of a European Pharmacopoeia, in particular on surgical sutures and on interaction between medicinal products and materials used in devices containing such medicinal products, provided that references to those monographs have been published in the Official Journal of the European Union.
Devices that are in conformity with the CS referred to in paragraph 1 shall be presumed to be in conformity with the requirements of this Regulation covered by those CS or the relevant parts of those CS. Manufacturers shall comply with the CS referred to in paragraph 1 unless they can duly justify that they have adopted solutions that ensure a level of safety and performance that is at least equivalent thereto.
Notwithstanding paragraph 3, manufacturers of products listed in Annex XVI shall comply with the relevant CS for those products.
Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I. Manufacturers of devices other than custom-made devices shall draw up and keep up to date technical documentation for those devices.
The technical documentation shall be such as to allow the conformity of the device with the requirements of this Regulation to be assessed. The Commission is empowered to adopt delegated acts in accordance with Article amending, in the light of technical progress, the Annexes II and III.
Manufacturers of custom-made devices shall draw up, keep up to date and keep available for competent authorities documentation in accordance with Section 2 of Annex XIII.
Where compliance with the applicable requirements has been demonstrated following the applicable conformity assessment procedure, manufacturers of devices, other than custom-made or investigational devices, shall draw up an EU declaration of conformity in accordance with Article 19and affix the CE marking of conformity in accordance with Article Manufacturers shall comply with the obligations relating to the UDI system referred to in Article 27 and with the registration obligations referred to in Articles 29 and Manufacturers shall keep the technical documentation, the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56available for the competent authorities for a period of at least 10 years after the last device covered by the EU declaration of conformity has been placed on the market.
In the case of implantable devices, the period shall be at least 15 years after the last device has been placed on the market.
Upon request by a competent authority, the manufacturer shall, as indicated therein, provide that technical documentation in its entirety or a summary thereof. A manufacturer with a registered place of business outside the Union shall, in order to allow its authorised representative to fulfil the tasks mentioned in Article 11 3ensure that the authorised representative has the necessary documentation permanently available.
Manufacturers shall ensure that procedures are in place to keep series production in conformity with the requirements of this Regulation. Changes in device design or characteristics and changes in the harmonised standards or CS by reference to which the conformity of a device is declared shall be adequately taken into account in a timely manner.
Manufacturers of devices, other than investigational devices, shall establish, document, implement, maintain, keep up to date and continually improve a quality management system that shall ensure compliance with this Regulation in the most effective manner and in a manner that is proportionate to the risk class and the type of device.
The quality management system shall cover all parts and elements of a manufacturer's organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation.
The quality management system shall address at least the following aspects: Manufacturers of devices shall implement and keep up to date the post-market surveillance system in accordance with Article Achievements in Public Health, Control of Infectious Diseases.
Deaths from infectious diseases have declined markedly in the United States during the 20th century ().This decline contributed to a sharp drop in infant and child mortality (1,2) and to the year increase in life expectancy (2).
PDF version: Use of Physical Restraint – Information module (PDF MB) PDF version: Video transcript - Use of Physical Restraint – Information module (PDF 65KB) Video transcript Slide 1. Welcome to the Department’s online information session for QI 2 – Physical Restraint for the National Quality Indicators Program in residential aged care services.
It goes without saying that you'll need insurance, but it's not something you should be sorting at the last minute as policies vary significantly, start coving you immediately for pre-trip problems and you need to spend a little time reading small print and making sure you don't overpay.
There are hundreds of travel insurance companies. Aljazeera tv had a main news item this morning making a big thing out of the failure of APEC leaders to be able to issue the usual agreed “bland communique”, and the very obvious “spat” – the “war of words” that had been waged there between Xi and Pence.
Summarise the main points of legal requirements and codes of practice for handling information in health and social care Under the data protection act we must make sure the information we handle is: used fairly and lawfully. This Regulation lays down rules concerning the placing on the market, making available on the market or putting into service of medical devices for human use and accessories for such devices in the Union.