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NSAI is now designated under the In Vitro Diagnostic Medical Devices Regulation (EU)  2017/746. 

NSAI is now able to provide conformity assessments under the IVDR and grant CE marked certificates to the scope documented on the NANDO database. NSAI will be performing conformity assessment activities under IVDR 2017/746, Annex IX Chapter I and Chapter II. View NSAIs full scope here.

The Designation represents a significant expansion in the scope of conformity assessment provided under the old IVDD.  In line with this expansion, NSAI is designated to perform conformity assessment activities for all Classifications of devices: Class A, Class B, Class C and Class D. 

NSAI’s IVDR scope of Designation includes, but is not limited to:

•    Devices intended to be used to determine markers of the specific blood grouping systems.
•    Devices intended to be used in screening, diagnosis, staging or monitoring of cancer.
•    Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents.
•    Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging.
•    Devices intended to be used for detection of pregnancy or fertility testing.
•    Devices which are controls.
•    Devices intended to be used for self-testing.

In accordance with Annex IX and MDCG 2019-13, NSAI will be performing sampling on Class B and Class C devices.

NSAI will be accepting applications for Class D devices. Applications will require case-by-case assessment and agreement between manufacturers and NSAI until such time as European Union Reference Laboratories (EURLs) become designated and operational. NSAI is committed to supporting Class D manufacturers in finding a route to market.

NSAI has achieved this designation ahead of the average designation timeline. We are excited to work with manufacturers to provide a high-quality conformity assessment service and are proud to be part of the European framework facilitating patient access to essential devices. 

For manufacturers wishing to engage under the IVDR, please contact Sales.Medical@nsai.ie

 

NSAI is now designated under Medical Device Regulation 2017/745

NSAI is now a designated Notified Body under MDR 2017/745, view the NANDO database.

NSAI’s scope of designation under MDR 2017/745 includes:

  • Active implantable devices
  • Active non-implantable devices for imaging, monitoring and/or diagnosis
  • Active non-implantable therapeutic devices and general active non-implantable devices
  • Non-active implants and long term surgically invasive devices
  • Non-active non-implantable devices
  • Reusable surgical instruments
  • Devices locally dispersed in the human body or intended to undergo a chemical change in the body
  • Devices without an intended medical purpose as per Annex XVI of the Regulation (conditional on Common Specifications being published)

The full scope can be viewed here.

The process for MDR application and certification is:

  • Complete an RFQ/application
  • Accept quotation/contract
  • Schedule Product/Technical documentation Review and QMS audit activity
  • Technical documentation review and QMS audit activity will happen simultaneously
  • Certification under MDR achieved and surveillance cycle begins

An overview of NSAI’s fees for conformity assessment activities under the MDR can be viewed here.

 

MDR and IVDR Publications

The new Medical Device & In-vitro Medical Device Regulations are now available in the Official Journal, having being published as:

  • Regulation (EU) 2017/745 Of The European Parliament and of the Council of 5th April 2017 on medical  devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.
  • Regulation (EU) 2017/746 Of The European Parliament and of the Council of 5th April 2017 on in vitro diagnostic medical  devices, and repealing Council Directives 98/79/EC Commission Decision 2010/227/EU.

Extension of the MDR Transitional Period and Removal of the 'sell off' periods document can be found here.

MDCG Guidance Documents

Follow all the latest guidance document from the MDCG by clicking here.

The clock is ticking, the countdown has started!

 

Contact NSAI Medical Devices
Email: medical.devices@nsai.ie
Telephone: 01 807 3800

Other FAQs

  • Determine if your device is a medical device or a product without an intended medical purpose referred to in Annex XVI

  • Determine the classification of your device per the requirements of Chapter V & Annex VIII, (Class I non-sterile, non-measuring and non- reusable surgical instrument medical devices and Class A in vitro medical devices do not require the intervention of a  Notified Body)
  • Identify the general safety and performance requirements that apply to your device (s) per Annex I
  • Identify the harmonised standards and common specifications required to demonstrate compliance to the general safety and performance requirements applicable to your device(s)
  • Determine the conformity assessment route appropriate to your device(s) Annexes IX, X or XI as appropriate
  • Determine the Technical documentation required to demonstrate compliance to the general safety and performance requirements applicable to your device(s)
  • Develop your technical documentation in compliance to the above requirements per Annex II 
  • Review  your post market surveillance, vigilance and market surveillance systems per the requirements of Chapter VII
  • Develop your post market technical documentation per the requirements of Annex III
  • Review your clinical evaluation and clinical investigations for compliance to Chapter VI  2017/745 for medical devices and clinical evidence, performance evaluation and performance studies for compliance to Chapter VI 2017/746 for in vitro diagnostic medical devices
  • Review your clinical evaluation and post market surveillance for compliance to Annex XIV 2017/745 for medical devices and interventional clinical performance studies and certain other performance studies for compliance to Annex XIV 2017/746 for in vitro diagnostic medical devices
  • Review your clinical investigations per the requirements of Annex XV 2017/745 for medical devices
  • Draw up your declaration of conformity in compliance to Annex IV
  • Develop your UDI –DI and UDI-PI
  • Obtain an SRN 
  • Apply to a duly designated Notified Body under Regulation 2017/745 &/or 2017/746
  • Revaluate the Notified Body Quality Management System in line with the requirements of 2017/745 & / or 2017/746

  • Apply for designation under 2017/745 & / or 2017/746

  • Liaise with the manufacturers to ensure a thorough understanding of the requirements by all economic operators