Our Latest News
Find the latest updates about medical devices below.
NSAI hosted two events on the 25th and 27th of February in Dublin and Galway.
These events focused on:
- Clinical requirements for the medical device regulation.
- Device classification and product technical file requirements.
- Quality system requirements.
- Brexit implications for medical device manufacturers.
To learn more, view the recording below, or download a copy of the Powerpoint presentation
On 5 April 2017, two new Regulations on medical devices were adopted, and they entered into force on 25 May 2017. They were:
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 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 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
In light of these changes, we would like to advise medical device manufacturers of the excellent resources below, kindly put together by the European Commission:
- Factsheet for manufacturers of medical devices
- Implementation model: medical devices
- Exhaustive list: requirements for medical devices manufacturers
The NSAI Medical Device department has just completed its latest Roadshow on the subject 'ISO 13485:2016 and the MDR - Major Changes and Impacts'.
Hosting a seminar in both Dublin and Galway NSAI Medical Device staff gave presentations on what's new in ISO 13485:2016 and the major changes and impacts the MDR will have on industry.
This latest NSAI presentation is now available to view here
Documents referenced during the ISO 13485:2016 presentation:
- ISO 13485:2016 NSAI Transtion Policy
- ISO 13485:2016 NSAI Technical Questionnaire (Word version is available from your NSAI auditor)
NSAI hosted two morning seminars on ISO 13485:2016 & the MDR in Dublin and Galway on the 18th & 20th May, The presentation given at these events is available below.
- Request a Quote
- Apply for Registration
- Substantial Change QMS
- Upload Documentation to NSAI
- General Conditions
- Client Agreement U.S
- Client Agremment Ireland
New website created by EU Commission to assist in communication on MDR/IVDR
The Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs (DG GROW) is launching a communication campaign on the new Regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR). They came into force on 25 May 2017 and a transitional period is foreseen until May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices.
- GOPA Com. has been chosen to undertake a series of targeted communication activities from 2018 onwards.
Medical Resource Links
- Medical Devices Directive (93/42/EEC)
- Active Implantable (90/385/EEC)
- In-VitroDiagnostic (98/79/EC)
- Health Canada
- European Commission (Medical Devices)
- IDA (Irish Development Agency)
- Enterprise Ireland
- Health Products Regulation Authority
- Medical Device Regulation 2017/ 745 EU
- In-vitro Diagnostic Regulation 2017/ 746 EU
NSAI European HQ
1 Swift Square
Dublin 9 D09 A0E4
T+ 353 1 807 3800
F+ 353 1 807 3878
NSAI Galway Office
Ballybrit Business Park
Galway H91 NX52
T+ 353 1 807 3800
20 Trafalgar Square
Nashua, NH 03063
T+ 1 603 882 4412
F+ 1 603 882 1985