Device Regulation definition

Device Regulation means any Law relating to any Regulated Product in the United States, the European Union or any other country or jurisdiction where a Regulated Product is marketed or sold.
View Source
Device Regulation means any national, state, local or foreign statute, regulation, judicial or administrative interpretation, guideline, recommendation or standard international guidance of any Governmental Authority to the extent applicable to the manufacture, use or sale of the Reload including, without limitation, to the extent applicable, Canadian Medical Device Conformity Assessment Scheme, the European Medical Device Directive 93/42/EEC, FDA Act, and QSR/GMP.
View Source

Examples of Device Regulation in a sentence

  • If the Products are qualified as medical devices, the execution of these GPC must be in compliance with: - the Medical Device Regulation, where by Medical Device Regulation we mean the Regulation of the Medical Devices and all the applicable italian legislation; - the Legislative Decree no.

  • Client has a need for certain services related to Medical Devices under the Medical Device Regulation 2002 intended for the U.K markets.

  • Client has a need for certain services related to Medical Devices under the Medical Device Regulation 2017/745 intended for the E.U markets.

  • In assessing whether Licensee is taking or has taken “reasonable best efforts” under this Section 2, the Parties acknowledge that Licensee operates in a large number of countries and in a highly complex regulatory environment, including for example the European Union Medical Device Regulation (EUMDR).

  • CONTRACT GIVER is responsible for the compliance with all applicable regulatory legal requirements to fulfill its obligations under the European Union Medical Device Regulation 2017/745 and the European Union In Vitro Diagnostic Medical Devices Regulation 2017/746 referring to its Distributor role.

  • Such laws may include, but are not limited to, Council Directive 93/42/EEC / Regulation (EU) 2017/745, and from 2020 May 20th Medical Device Regulation (EU) 2017/745, applicable parts of FDA’s regulations in 21 CFR Parts 800 to 898, and other country medical device laws, regulations and directives.

  • The material financial terms of this Agreement shall be Confidential Information of each Party and, as such, shall be subject to the provisions of this Article 7.

  • Minor (Small) nonconformity: Unsystematic deviations, which do not affect the overall system, from quality management system standard requirements, EU 2017/745 Medical Device Regulation, product-related standard/common specifications, regulations, MDCG documents and other documents accepted by MDCG and/or customer's documentation requirements.

  • Mutually I/PIs (as defined in Canadian Medical Device Regulation) and MDR reportable events (as defined by FDA regulations).

  • Labeling will be conducted under Article 16 (1(a)) of the European Union Medical Device Regulation with such responsibilities set forth in the Quality Agreement.

Related to Device Regulation

  • Market Abuse Regulation means Regulation (EU) No 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse;

  • TUPE Regulations means the Transfer of Undertakings (Protection of Employment) Regulations 2006, as amended.

  • SEBI Regulations means the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015 together with the circulars issued thereunder, including any statutory modification(s) or re-enactment(s) thereof for the time being in force.

  • SBE Regulations means the written regulations and procedures adopted pursuant to this chapter for procurement of Supplies, Services and Public Works.

  • EU Regulation means a regulation within the meaning of Article 288 of the Treaty on the Functioning of the European Union;