MDR Information
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- MDR Information
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
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
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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 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
- Review your clinical evaluation and post market surveillance for compliance to Annex XIV 2017/745 for 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
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Revaluate the Notified Body Quality Management System in line with the requirements of 2017/745
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Apply for designation under 2017/745
- Liaise with the manufacturers to ensure a thorough understanding of the requirements by all economic operators