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2019-05-01· With the publication of Europe’s Medical Device Regulation (EU 2017/745) and In Vitro Diagnostic Regulation (EU 2017/746), some companies that contract manufacture or relabel devices are wondering if they will be considered the “legal manufacturer” of the device they sell.Much of the confusion around this issue stems from the assumption that there can be only …
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2020-08-12· The European Medical Device Regulation 2017/745 requires the compilation of technical documentation. See below a summary of the information to be included to comply with EU MDR Technical Documentation. The manufacturer shall develop technical documentation for each of its devices [1]. The technical documentation must be such that it allows the ...
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As a manufacturer of a medical device, you must ensure that you meet the relevant regulatory requirements before placing your product onto the market; for the EU, these are outlined in the Medical Device Regulation (MDR) (EU) 2017/745 and, for the UK, the UK Medical Devices Regulations (UK MDR) 2002.
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Regulation (UE) 2017/745 concerning medical devices . IMQ is Notified Body for the new Medical Device Regulation (MDR). IMQ has been designated by the Italian Ministry of Health and Ministry of Economic Development on July 19, 2019. On August 20, the notification has been published in NANDO, the European Commission database.
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2021-05-25· With the EU Medical Devices Regulation (MDR)''s Date of Application happening and no Mutual Recognition Agreement in place, Switzerland is a third country for medical devices. Emergo by UL explains what that means and how manufacturers and importers need to proceed to place European goods on the Swiss market and vice versa.
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The Medical Devices Regulation ( Regulation (EU) 2017/745) applies since 26 May 2021, following a four-year transition period. Manufacturers must comply with the Regulation when placing new medical devices on the market. It repeals Directive 93/42/EEC on medical devices and the Directive 90/385/EEC on active implantable medical devices.
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Jul 22, 2021· Actual legislation title: REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices. Includes a clear reference to parts or products being covered by the declaration. This can be: Company level or blanket statement without individual part (s)/product (s) listing, e.g.
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2021-08-17· Within the EU Medical Device Regulation 2017/745, the essential requirements (ER) which were the core of the previous medical device directives (MDD) have been replaced by the so-called General Safety and Performance Requirements (GSPR).Each manufacturer shall provide evidences of compliance to the GSPR; in general GSPR are quite similar to the …
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2019-05-27· Regulation (EU) 2017/745 on medical devices will apply from 26 May 2021, Regulation (EU) 2017/746 on in vitro diagnostic medical devices from 26 May 2022. This means that distributors of medical devices will have to comply …
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2018-03-11· Medical Device definition from the Medical Device Regulation MDR 2017/745 The full EU MDR Medical Device definition is: ‘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 …
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2019-05-01· With the publication of Europe’s Medical Device Regulation (EU 2017/745) and In Vitro Diagnostic Regulation (EU 2017/746), some companies that contract manufacture or relabel devices are wondering if they will be considered the “legal manufacturer” of the device they sell.Much of the confusion around this issue stems from the assumption that there can be only …
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2019-05-27· Regulation (EU) 2017/745 on medical devices will apply from 26 May 2021, Regulation (EU) 2017/746 on in vitro diagnostic medical devices from 26 May 2022. This means that distributors of medical devices will have to comply …
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for the supply chain Person Responsible for Regulatory Compliance EU medical devices database EUDAMED Implementation delayed until 2022 Device registration including UDI clinical, labeling and safety data Better traceability of medical devices using UDI, Verifications throughout the supply chain UDI on the label, implant card and patient leaflet
Chat Online2020-06-22· Restricted Substances under the New Medical Devices Regulation. Number of restricted substances will increase every year. 22 June 2020. In addition to addressing requirements for nanomaterials, one of the unique additions to the Medical Devices Regulation (EU) 2017/745 (“MDR”), is the regulation of carcinogenic, mutagenic or toxic to reproduction …
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The European Medical Device Regulation (MDR 2017/745) took effect on May 26, 2021. Manufacturers holding valid Medical Devices Directive (MDD) CE Marking certificates can continue to place those devices on the European market until certificate expiration or May 2024, whichever comes first.
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Medical devices may also be used in high-risk surgical procedures and intensive care settings, where improper storage along the supply chain, amongst other aspects, may lead to undesirable, and in some cases extremely serious, consequences. Regulation 2017/745 on medical devices and Regulation 2017/746 on in vitro diagnostic devices
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The European Medical Devices Regulation 2017/745 (MDR) now applies in the world’s second-largest medical device market. The new Regulation introduces major changes to how medical device manufacturers obtain CE Marking and maintain access to the European market, yet some companies may have yet to come fully into compliance with these new requirements, or …
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2018-12-31· MDR Quality Plan – for EU Regulation 2017/745 Compliance Posted by Rob Packard on December 31, 2018. This article outlines an EU MDR quality plan for compliance with European Regulation 2017/745 for medical …
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Europe’s Medical Devices Regulation 2017/745 (MDR) took effect in May 2021. For companies marketing their devices in the European Union, maintaining CE Mark certification means MDR compliance regardless of challenges such as Notified Body staff shortages and work backlogs.
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2020-06-22· Restricted Substances under the New Medical Devices Regulation. Number of restricted substances will increase every year. 22 June 2020. In addition to addressing requirements for nanomaterials, one of the unique additions to the Medical Devices Regulation (EU) 2017/745 (“MDR”), is the regulation of carcinogenic, mutagenic or toxic to reproduction …
Chat OnlineBQ+ Medical was founded in 2015. BQ+ is a recombination of Medical business from former Nelson Techno Medical Co., Ltd.elson Techno Medical Co.,Ltd was founded in 2005 by Ms. Ronia Cao. Former Nelson Techno Medical Co., Ltd was active in 2 business lines, one is IV components for human medical use, and the other is artificial Insemination devices for animal use.
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