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Regulation (EU) 2017/746

Regulation (EU) 2017/746

of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices

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IVD Directive Harmonised Standard

IVD Directive Harmonised Standard

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What is an IVD?
An IVD, or in vitro diagnostic medical device, is any device that is intended to be used to test human samples for a medical purpose. IVDs can be, but not limited to an instrument, reagent, kit, control material, software or system. For a more complete definition of an IVD, download our free IVDeology App and check out the definitions in article 2.

What is a Quality Management System and do I need one?
A Quality Management System, or QMS, is a defined, formal process that documents procedures, processes and the required responsibilities within an organisation to maintain a quality culture. This allows a systematic approach to the design, development, manufacturer and delivery of devices. For IVDs and medical devices, the internationally recognised approach for a QMS is described within the international standard ISO 13485, published in 2016. An effectively implemented QMS can add real value to an organisation by reducing time and waste and improving product consistency and improvements. For more information on Quality Management Systems, check out our blogs posts.

What documents are needed to place IVDs on the market?

IVD devices require a technical file to be drawn up to demonstrate that the product is safe and meets the relevant regulatory requirements. For devices registering under the IVD Directive, or following current UKCA rules, they would need to meet the “Essential Requirements” listed in Annex I and have a technical file complying with the requirements of Annex III. For devices registering under the IVD Regulation, they would need to meet the “General Safety and Performance Requirements” defined in Annex I and have a technical file complying with the requirements of Annex II & III. Once these have been met, the manufacturer can then draw up a Declaration of Conformity stating that the device is in compliance with the relevant regulation.

What is a notified body and how do I get one?

A notified body is an organisation designated by an EU member state who assess the conformity of certain products before they are placed on the EU market. Notified bodies are required for the conformity assessment of Class D, C, B, and Class A sterile devices. An updated list of notified bodies can be found here EUROPA - European Commission - Growth - Regulatory policy - NANDO.   

What is CE marking?

The Conformitè Europëenne (CE) Mark is the mandatory marking for regulating the goods sold within the European Economic Area (EEA). It indicates that a product has been assessed by a manufacturer and deemed to meet the EU safety, health and environmental protection requirements, and is a requirement for products to be sold on the European market. For IVD’s, the relevant regulation from 26th May 2022 is the IVD Regulation 2017/746/EU

How do I place an IVD in the EU market?

To place an IVD on the EU market, devices must conform to the IVD Regulation 2017/746/EU.

For manufacturers outside the EU, an EU Authorised Representative must be appointed who is located within Europe to take responsibility for the device. Their name and address must also be added to the IFU and outer labelling

How do I place an IVD in the UK market?

To place an IVD on the market in Great Britain (England, Wales and Scotland), devices must conform to the Medical Devices Regulation 2002 (UK MDR 2002) and be registered with the MHRA.

Only manufacturers that are based in the UK can register directly with the MHRA. For manufacturers outside the UK, a UK Responsible Person must be appointed to take responsibility for and register the device.

The requirements for placing devices on the market in Northern Ireland are different. CE marking will continue to be necessary and UK-based manufacturers will need to appoint an EU Authorised Representative. The UKNI marking will also be required if the conformity assessment has been carried out by a UK Notified Body.

IVDeology offers a UK Responsible Person service for manufacturer’s outside of the UK, please contact us if this is something that you are interested in.

Is software an IVD?

Software is considered an IVD if it’s intended purpose is to be used either alone or in combination for the in vitro examination of specimens derived from the human body. Therefore, software as part of an instrument and apps are included in the definition of IVD’s and are covered by the same regulations.

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