In vitro diagnostic medical device is any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
In vitro diagnostic medical device is any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, piece of equipment, software or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information on one or more of the following:
The European Union In Vitro Medical Device Regulation EC 2017/746 (IVDR) is the medical devices regulation for in vitro diagnostic products that are placed on the European Union. Regulation EC 2017/746 repeals the existing directive on in vitro medical devices - In Vitro Medical Device Directive 98/79/EC (IVDD). The Regulation was published and came into force in May 2017. In vitro diagnostic medical devices approved under IVDD will have a transition time until May 2022 to meet provisions of the new IVD regulation. According to IVDR in vitro diagnostic medical devices are divided into classes A, B, C and D.
In the USA all medical devices including in vitro diagnostic devices fall under unified FDA regulations, which are a part of the US Code of Federal Regulations (CFR). All medical devices are subject to a unified classification (classes I, II, III) and regulatory processes: 510(k) exemption, 510(k) и Premarket Approval.
In LATAM countries in vitro diagnostic medical device markets are regulated by national standards of separate countries. However, those standards are similar and largely harmonized in Mercosur countries (Argentina; Brazil; Paraguay; Uruguay and associated countries). Mexico which is not a Mercosur member differs from other Latin American countries in terms of the medical device regulations. In Mercosur countries there are four classes of in vitro diagnostic medical devices: classes I, II, III and IV. In Mexico - classes I, II and III.
The European Union In Vitro Medical Device Regulation EC 2017/746 (IVDR) is the medical devices regulation for in vitro diagnostic products that are placed on the European Union. Regulation EC 2017/746 repeals the existing directive on in vitro medical devices - In Vitro Medical Device Directive 98/79/EC (IVDD). The Regulation was published and came into force in May 2017. In vitro diagnostic medical devices approved under IVDD will have a transition time until May 2022 to meet provisions of the new IVD regulation. According to IVDR in vitro diagnostic medical devices are divided into classes A, B, C and D.
In the USA all medical devices including in vitro diagnostic devices fall under unified FDA regulations, which are a part of the US Code of Federal Regulations (CFR). All medical devices are subject to a unified classification (classes I, II, III) and regulatory processes: 510(k) exemption, 510(k) и Premarket Approval.
In LATAM countries in vitro diagnostic medical device markets are regulated by national standards of separate countries. However, those standards are similar and largely harmonized in Mercosur countries (Argentina; Brazil; Paraguay; Uruguay and associated countries). Mexico which is not a Mercosur member differs from other Latin American countries in terms of the medical device regulations. In Mercosur countries there are four classes of in vitro diagnostic medical devices: classes I, II, III and IV. In Mexico - classes I, II and III.
MDRC assists medical device companies with regulatory approvals and placing medical devices on the European, USA and Latin American markets. We bring manufacturer’s technical documentation, QMS, post market surveillance and risk management systems into compliance with regulatory requirements of your strategic markets. Regardless of your IVD's class - from wash buffers (class A) to automated analyzers and reagent kits belonging to class D.
MDRC assists medical device companies with regulatory approvals and placing medical devices on the European, USA and Latin American markets. We bring manufacturer’s technical documentation, QMS, post market surveillance and risk management systems into compliance with regulatory requirements of your strategic markets. Regardless of your IVD's class - from wash buffers (class A) to automated analyzers and reagent kits belonging to class D.
What regulatory approval procedures are needed to place a medical device on a market depends on the type and class of the device. Length and complexity of the procedures may vary from very simple, quick and inexpensive to extremely intricate, lengthy and resource-intensive.
What regulatory approval procedures are needed to place a medical device on a market depends on the type and class of the device. Length and complexity of the procedures may vary from very simple, quick and inexpensive to extremely intricate, lengthy and resource-intensive.
We will put your medical devices on your strategic markets in a timely and cost-efficient manner. MDRC are experts on all types and classes of medical devices. Entrust your regulatory affairs to the professionals.
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