Medical Devices Legislation definition

Medical Devices Legislation means medical device legislation applicable to the Solution. For the avoidance of doubt, if the Solution is made available on the EU market, Medical Device Legislation shall include Directive 93/42/EEC and Regulation (EU) 2017/745.
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Examples of Medical Devices Legislation in a sentence

  • Once the device is intended to be placed on the market, it is subject to the requirement of CE marking in accordance with the EU Medical Devices Legislation as well as RED, if it consists of radio equipment within the scope of the RED.Machinery DirectiveUnder the Machinery Directive, CE marking is not required for partly completed machinery.

  • Otherwise, if classified as a medical device, the general conditions for review, approval and marketing are as per the Medical Devices Legislation.

  • A CE marking will only be issued by the notified body, and the device will subsequently only be placed on the market, if the device conforms with requirements set out under the Medical Devices Legislation.

  • This includes managing exposures around the benchmark.The Responsible Entity and the Investment Manager monitor the Fund’s interest sensitivity position on a daily basis.Interest rate risk is not considered to be significant to the Fund except in relation to investments in interest bearing securities.

  • There are no specific provisions under Medical Devices Legislation relating to the processing of personal data by manufacturers/distributors/healthcare units.

  • General Medical Devices A conformity assessment procedure must be carried out to confirm that the design and/or production ensures compliance with Medical Devices Legislation.

  • What specific rules exist for advertising and promoting medical devices?The Medical Devices Legislation does not specifically regulate the advertising of medical devices.On the 27 June 2011, a new Irish Code of Ethics will be launched by the Minister for Health and Children in Ireland, which will be binding on all Irish Medical Devices Association (“IMDA”) and Irish Medical and Surgical Trade Association (“IMSTA”) members.

  • In fact, we assume that all backward transitions in the suggested mech- anical cycle are characterized by rates, which are very slow in comparison with the corresponding forward rates.

  • First of all, the manufacturer should determine if their product falls within the scope of Medical Devices Legislation – for this it should have a medical purpose and its primary mode of action will typically be physical.

  • Rockstroh JK, Spengler U, Sudhop T, Ewig S, Theisen A, Hammerstein U , et al.

Related to Medical Devices Legislation

  • NICs Legislation means the Social Security (Categorisation of Earners) Regulations 1978;

  • FOI Legislation means the Freedom of Information Xxx 0000, all regulations made under it and the Environmental Information Regulations 2004 and any amendment or re-enactment of any of them; and any guidance issued by the Information Commissioner, the Department for Constitutional Affairs, or the Department for Environment Food and Rural Affairs (including in each case its successors or assigns) in relation to such legislation;

  • Data Protection Legislation means the Data Protection Act 1998 and all applicable laws and regulations relating to processing of personal data and privacy, including where applicable the guidance and codes of practice issued by the Information Commissioner or relevant Government department in relation to such legislation;

  • UK Data Protection Legislation means all applicable data protection and privacy legislation in force from time to time in the UK including the UK GDPR; the Data Protection Act 2018; the Privacy and Electronic Communications Directive 2002/58/EC (as updated by Directive 2009/136/EC) and the Privacy and Electronic Communications Regulations 2003 (SI 2003/2426) as amended.

  • customs legislation means any legal or regulatory provisions applicable in the territories of the Parties, governing the import, export and transit of goods and their placing under any other customs regime or procedure, including measures of prohibition, restriction and control;

  • Applicable Legislation means any statute of Canada or a province thereof, and the regulations under any such named or other statute, relating to warrant indentures or to the rights, duties and obligations of warrant agents under warrant indentures, to the extent that such provisions are at the time in force and applicable to this Indenture;

  • primary legislation means an Act, Act of the Scottish Parliament or Act or Measure of the National Assembly for Wales;

  • Privacy Legislation means all laws and regulations, including (without limitation) the laws and regulations of the European Union, the European Economic Area and their member states, which are applicable to the processing of Personal Data under this Agreement, including (without limitation) the EU General Data Protection Regulation (2016/679) (“GDPR”); and

  • securities legislation means statutes concerning the regulation of securities markets and trading in securities and the regulations, rules, forms and schedules under those statutes, all as amended from time to time, and the blanket rulings and orders, as amended from time to time, issued by the securities commissions or similar regulatory authorities appointed under or pursuant to those statutes; “Canadian securities legislation” means the securities legislation in any province or territory of Canada and includes the Securities Act (British Columbia); and “U.S. securities legislation” means the securities legislation in the federal jurisdiction of the United States and in any state of the United States and includes the Securities Act of 1933 and the Securities Exchange Act of 1934; and

  • Bail-In Legislation means, with respect to any EEA Member Country implementing Article 55 of Directive 2014/59/EU of the European Parliament and of the Council of the European Union, the implementing law for such EEA Member Country from time to time which is described in the EU Bail-In Legislation Schedule.

  • Equality Legislation means any and all legislation, applicable guidance and statutory codes of practice relating to diversity, equality, non-discrimination and human rights as may be in force from time to time in England and Wales or in any other territory in which, or in respect of which, the Supplier provides the Services;

  • Data Protection Laws and Regulations means all laws and regulations, including laws and regulations of the European Union, the European Economic Area and their member states, Switzerland and the United Kingdom, applicable to the Processing of Personal Data under the Agreement.

  • other applicable legislation means any other legislation applicable to municipal supply chain management, including –

  • UK Bail-in Legislation means Part I of the United Kingdom Banking Act 2009 and any other law or regulation applicable in the United Kingdom relating to the resolution of unsound or failing banks, investment firms or other financial institutions or their affiliates (otherwise than through liquidation, administration or other insolvency proceedings).

  • Information Legislation means the Freedom of Information Act 2000, the Environmental Information Regulations 2004 and the Data Protection Act 1998 and any other subordinate legislation or Codes of Practice in relation to such legislation.

  • Bribery Legislation means the Bribery Act 2010 and any subordinate legislation made under it from time to time together with any guidance or codes of practice issued by the government concerning the legislation;

  • Enabling Legislation means the CCA;

  • Sanctions Laws and Regulations means any sanctions, prohibitions or requirements imposed by any executive order (an “Executive Order”) or by any sanctions program administered by OFAC.

  • provincial legislation means legislation contemplated in section 10 of the Act promulgated by the Province;

  • Tax Legislation means any statute, statutory instrument, enactment, law, by-law, directive, decree, ordinance, regulation or legislative provision or generally applicable ruling (such as a revenue ruling issued by the U.S. Internal Revenue Service) enacted, issued or adopted providing for, imposing or relating to Tax; and

  • Protection Legislation means (i) the GDPR; (ii) the Data Protection Act 2018 to the extent that it relates to the processing of Personal Data and privacy; and (iii) all applicable Law relating to the processing of Personal Data and privacy, including where applicable the guidance and codes of practice issued by the Information Commissioner, in each case as amended, supplemented or substituted from time to time; Domestic Successor means, as the context requires, either:

  • previous planning legislation means any planning legislation that is repealed by the Act or the provincial legislation;

  • Union harmonisation legislation means any Union legislation harmonising the conditions for the marketing of products;

  • Laws and Regulations means federal, state, local and foreign statutes, laws, ordinances, regulations, rules, codes, orders, constitutions, treaties, principles of common law, judgments, decrees or other requirements;

  • Environmental Legislation means any laws, statutes, regulations, orders, bylaws, permits or lawful requirements of any governmental authority with respect to environmental protection;

  • medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes: