medical needle free representative europe

  • Frequently Asked Questions on medical devicesFAQ MD

    Economic stakeholders (MDR operators) are manufacturers, authorised representatives, importers, distributors and persons referred to in Article 22(1) and 22(3) EU-MDR.(Art. 4 MedDO)Manufacturer. Any natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.

  • Top 11 QuestionsEuropean Authorized Representative

     · If you look at the definition extracted from the new Medical Device Regulation 2017/745 ‘Authorized Representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under

  • EN ISO 9626European Standards

    EN ISO 9626 EN ISO 9626 Stainless steel needle tubing for the manufacture of medical devicesRequirements and test methodsISO 9626 2016 applies to rigid stainless steel needle tubing suitable for use in the manufacture of hypodermic needles and other medical devices primarily for human use.

  • Needle Free Drug Delivery Devices Market Growth,

    There are several universities, hospitals, and research centers collaborating and sponsoring the trials for needle-free jet injection across the world, majorly in the United States, the United Kingdom, and China. In 2017, Takeda and Portal Instruments announce collaboration to develop needle-free drug delivery device.

  • Medical devicesEuropean Commission

    Short name Medical devices. Base Council Directive 93/42/EEC of 14 June 1993 concerning medical devices OJ L 169 of 12 July 1993. Modification Directive 93/68/EEC [CE Marking] Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices Directive 2000/70/EC of the European Parliament and of the Council of 16 November 2000

  • HomeMedical Device Regulation and ISO quality standard

    Want to Master Medical Device Regulation & learn how to put a product on the market in Europe. Easy Medical Device is a platform for tools and resources for Regulatory Affairs, Quality Management, Regualtory Compliance. Learn how to choose your notified body or how the device regulation is different in other countries

  • Needle-free reconstitution system

     · North America option South America 5 05 06 Europe 4 0 Asia Pacific 6 862 400 West Pharmaceutical Services, Inc. 53 erman O West Drive Exton PA 9341 For more information visit westpharma The Mix2Vial® needle-free system enables simple, fast vial-to-vial transfer and mixing for the reconstitution of

  • Terumo® Syringe with/without Needle

    Terumo Syringes offer a reliable and health-care budget friendly platform for all parenteral applications. Engineered with advanced materials intended to provide smoother and more comfortable injections, Terumo Syringes compliment hypodermic needle function and procedural accuracy. Designed for single-use injections immediately after filling or

  • European Authorized RepresentativeI3CGLOBAL

    According to the EU MDR 2017/745 and EU IVDR 2017/746, European Authorized Representative is mandatory for Non-European manufacturers wishing to sell the medical device and (IVDs) on the European market. EC Rep is a natural or one that is legalized and established within the EU, who has received and accepted a written mandate or decree from the

  • European Authorized Representative (EC REP)

    European Authorized Representative for Medical Devices (MDR (EU) 2017/745) and In Vitro Diagnostic Devices (IVDR (EU) 2017/746). The appointment of an European Authorized Representative (EC REP) for the Member States of the EEA is a requirement of the European Medical Device RegulationsMedical Device Regulation (MDR (EU) 2017/745) and In Vitro Diagnostic Medical Device Regulation (IVDR (EU

  • SmartSite extension setsBDAdvancing the World of

    BD offers a variety of extension sets to help meet clinical needs throughout the hospital. Our sets are available with the award-winning SmartSite™ needle-free valve and split septum injection port. We recognize the concerns about IV sets that contain DEHP and offer DEHP-free extension sets to meet your needs in NICU, peds, ICU and other areas.

  • Classification of Syringe (nozzle) of needle free

     · Dec 19, 2019. #5. Dec 19, 2019. #5. Empty syringes intended for manual administration of a drug to a patient are Class I (sterile / measuring). If they can be used in an automated syringe pump (normally larger sizes, 20ml nominal capacity and greater) they jump up a classification to IIa. If you pre-fill the syringe with drug product yourselves

  • EU Sharps Injuries Draft Implementation Guidance

     · EU Framework Agreement on sharps injuries, negotiated by the EU social partners EPSU and HOSPEEM, and also responds to a European Parliament report on needlestick injuries. The Network is open to national and European professional institutions, representative associations, unions and other interested organisations committed to

  • European Authorized Representative, EC REP, medical

    European Authorized Representative (EC REP) Overview Foreign Medical Device manufacturers who do not have a physical location in Europe must appoint a European Authorised Representative (also referred as EC REP or EAR) based in any member countries of the European Union, who are a part of the countries recognizing CE mark.

  • A New Generation Medical Device Company Applied

    A New Generation Medical Device Company Applied Medical. As a new generation medical device company, Applied Medical is equally committed to improving the accessibility and affordability of high-quality healthcare globally. We achieve this through a vertically integrated business model that enables our team members to develop technologies


     · The EU Representative is subject to EU law. The device manufacturer, however, resides outside the EU Legal Jurisdiction and may decide not to cooperate with the EU authorities. To minimize the Authorized Representative's exposure of being on the receiving end of a manufacturer's liabilities, the penalty clauses provide recourse.

  • Medical device Authorized Representative, US FDA agent

    A Medical Device authorized representative is any natural or legal person having a local entity in the territory, who is explicitly designated by the manufacturer, acts and may be addresses the authorities and bodies in the country on behalf of the manufacturer. Pre-requisites and responsibilities of a Medical Device authorized representative

  • Role of European Authorized RepresentativeEC Rep

     · 4) Do independent Authorized Representatives sell medical devices in Europe? No, they do not sell products they do not compete with your distributors and/or agent. 5) How do we select an Authorized Representative? First you choose an Authorized Representative that is experienced and well versed in the areas of Medical Devices and related

  • Who are the world's biggest needle and syringe

     · B. Braun Melsungen is currently the largest Europe-based manufacturer of needle and syringe products in the worldas well as being one of the biggest European medical device firms generally. The company, which is based in the town of Melsungen in central Germany, generated sales in excess of €7.4bn ($8.75bn) in 2019, and employs close to

  • PharmaTimes Medical Sales Representative, Europe Jobs

    Job results Medical Sales Representative, Europe Click on the Details/Apply button next to each job to see the full posting jobs, or add the job to your Wish List.Click on the Select Job button next to the jobs that interest you and click View Jobs to see several jobs together.. 5 Jobs found, viewing matches 15.

  • PENTAX Medical (Global)

     · PENTAX Medical Europe to launch single-use bronchoscope. PENTAX Medical ONE Pulmo obtains CE mark, offering clinicians an advanced solution by broadening clinical applications beyond standard disposable scopes in pulmonary care. HAMBURG, 26th May, 2021 PENTAX Medical Europe, a leading company in the endo

  • Infinix-i Angiography Needle Guidance Canon Medical

    Infinix-i. Infinix systems incorporate the industry's most extensive set of automated and user-selectable dose management tools designed to minimize patient X-ray exposure while maintaining unsurpassed image quality. Supports real time navigation of needle insertion during percutaneous procedures such as biopsy or RF ablation.

  • Infinix-i Angiography Needle Guidance Canon Medical

    Infinix-i. Infinix systems incorporate the industry's most extensive set of automated and user-selectable dose management tools designed to minimize patient X-ray exposure while maintaining unsurpassed image quality. Supports real time navigation of needle insertion during percutaneous procedures such as biopsy or RF ablation.

  • Medical devices European Medicines Agency

    Medical devices are products or equipment intended generally for a medical use and are regulated at Member State level. The Regulations on Medical Devices (Regulation (EU) 2017/745) and on In-Vitro Diagnostic Devices (Regulation (EU) 2017/746) changed the European legal framework for medical devices, introducing new responsibilities for the European Medicines Agency (EMA) and national

  • Europe Needle-free IV Connectors MarketCardinal

     · Europe Needle-free IV Connectors MarketCardinal Health, Inc, Amsino International, Inc, ICU Medical, Inc, Vygon S.A, Baxter International Inc, Becton, Dickinson and Company, B.

  • MedNet GmbH

    – The nSyte Connector for Needle-free Access 11.07.2018 With the nSyte connector, NP Medical offers a secure and cost effective needle-free solution for the most common fluid