Placing A Medical Device On The Great Britain, Northern Ireland And European Union (EU) Markets From 1 January 2021

Overview

From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system.

This guidance provides information on how the UK system will operate, including for:

• Getting your device certified
• Conformity marking your device
• Registering your device with the MHRA

This guidance is divided into sections on the different rules that will apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.

For Northern Ireland, different rules will apply to those in Great Britain after the transition period. For more information on the regulatory system for medical devices in Northern Ireland, please see ‘Regulation of medical devices in Northern Ireland’

This guidance does not cover other ‘New Legislative Framework’ products, which are subject to separate guidance.

The proposals outlined in this guidance notice will take effect through legislative changes that will be introduced later in 2020. They are still therefore subject to parliamentary approval.

This information is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations.

Summary of key requirements for placing a device on the Great Britain market

From 1 January 2021, there will be a number of changes to how medical devices are placed on the market in Great Britain. These are:

• • CE marking will continue to be used and recognised until 30 June 2023

• Certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023

• A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from 1 January 2021

• From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering:

• 4 months for Class IIIs and Class IIb implantables, and all active implantable medical devices

• 8 months for other Class IIb and all Class IIa devices

• 12 months for Class I devices

• The above 12-month grace period will not apply to manufacturers of Class I devices and general IVDs that are currently required to register with the MHRA.

• If you are a manufacturer based outside the UK and wish to place a device on the UK market, you will need to establish a UK Responsible Person who will take responsibility for the product in the UK. Further detail on the UK Responsible Person is set out below.

The information as given on the weblink

https://www.gov.uk/guidance/regulating-medical-devices-from-1-january-2021 includes the following :

• Legislation that will apply to Great Britain

• The EU Medical Devices Regulation (MDR) and EU in vitro Diagnostic Medical Devices Regulation (IVDR) from 1 January 2021

• The role of the MHRA

• Requirements for those manufacturing and supplying devices in the UK

• Regulation of medical devices in Northern Ireland

• Placing a medical device on the EU market

• CE marking for the EU market after the transition period

Qosina Partners with Resolution Medical to Offer a 3D-Printed Sterile Nasal Swab for COVID-19 Testing

Ronkonkoma, NY, USA, October 6, 2020—Qosina is pleased to announce they now carry a sterile 3D-printed nasopharyngeal COVID-19 testing swab for nasal mucosa specimen collection.

Developed by Resolution Medical, an in vitro diagnostic and medical device manufacturer, the innovative 3D-printed sterile swab is a cost-effective alternative to the traditional, flocked nasopharyngeal swab. It is produced quickly by using alreadyexisting, industry-approved materials and the Carbon Digital Light SynthesisTM (Carbon DLSTM) 3D printing process. The swab is 5.9 inches in length, and the swab head features a soft, lattice-style cage around a flexible helical core, allowing the swab to more easily conform to the organic pathway of the nasal cavity. The unique, lattice-structured dome tip combines comfort and durability for optimal patient experience and captures sufficient specimen for testing. This sterile swab comes individually packaged and has a shelf life of six months.

“As a leader in swabs provided to the medical industry, we are excited to add the 3D-printed swab to our product offering,” said Scott Herskovitz, President and CEO of Qosina Corp. “Its creative design meets the growing demand from our customers for high quality COVID-19 testing swabs. Our mission is to provide the best customer experience possible by helping our customers find, order and receive quality medical components quickly and accurately, and this partnership is the perfect fit to support our mission.”

To order the sterile 3D-printed COVID-19 testing swab or Qosina’s additional sterile swab offerings, contact Qosina at +1(631) 242-3000, or email sales@qosina.com.

Founded in 1980, Qosina is a leading global supplier of OEM single-use components to the medical and pharmaceutical industries. Qosina’s philosophy is to address its customers’ need to reduce time to market by providing thousands of stock components. The company’s vast catalog features more than 5,000 products shown in full-scale illustrations on a onecentimeter grid. Qosina offers free samples of most items, low minimum order requirements, just-in-time delivery, modification of existing molds, and new product design and development. Qosina is ISO 13485, ISO 9001, ISO 22301 and ISO 14001 certified, and operates in a 95,000 square-foot facility with an ISO
Class 8 Clean Room. To learn about Qosina’s full component offering, which includes the newest products, visit www.qosina.com or call +1 (631) 242-3000. Visit Qosmedix, Qosina’s cosmetics division, at www.qosmedix.com. Qosmedix is a certified global supplier of beauty tools and accessories to the cosmetic, skincare, spa and salon industries.

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