Our Latest News

August 2018

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:

March 2017

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:


May 2016

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.

News on future events can be accessed on the NSAI Seminars web page as it becomes available.  You can also receive information on NSAI seminars direct by subscribing to
the NSAI E-zine.

Registration Documentation

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.

Learn More

Contact Details

Europe Offices
NSAI European HQ
1 Swift Square
Northwood, Santry
Dublin 9 D09 A0E4
Ireland

T+ 353 1 807 3800
F+ 353 1 807 3878
E medical.devices@nsai.ie 

NSAI Galway Office
Ballybrit Crescent
Ballybrit Business Park 
Galway H91 NX52
Ireland


T+ 353 1 807 3800
medical.devices@nsai.ie 

USA Office

NSAI Inc.
20 Trafalgar Square
Suite 603
Nashua, NH 03063
USA


T+ 1 603 882 4412
F+ 1 603 882 1985
E info@nsaiinc.com