Our Latest News
Find the latest updates about medical devices below.
NSAI are making changes to enhance the CE marking process for our clients under the new regulations. We have gathered data on the technical documentation reviews which have been conducted under MDR 2017/745 so far. Analysis of this data has shown us that the 1st round of queries which NSAI issues to its clients is primarily focused on administrative issues. These include requests for documents which have been omitted from the initial submission, or to request that the data be submitted in a searchable format. There is also a trend regarding insufficient document details, such as signatures, all of which prevents a review from proceeding.
To read the full communication, click here.
As a result of Covid-19 and in an effort to continue certifying medical devices and their associated management systems, remote auditing is now permissible in certain circumstances. The NSAI medical devices team have created a short webinar on “how a manufacturer can prepare for a remote audit”, available here.
NSAI is now a designated Notified Body under MDR 2017/745, and available to view on the NANDO database here.
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.
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:
- 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
- Team NB
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