Our Latest News
Find the latest updates about medical devices below.
Extension of the MDR Transitional Period and Removal of the 'sell off' periods
Find out more here
NSAI has achieved designation under the in vitro Diagnostic Regulation 2017/746.
This means that 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.
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.
Click 'full announcement' to view all the details.
For manufacturers wishing to engage under the IVDR, please email us at Sales.Medical@nsai.ie
Extension to MDR/IVDR
Following the positive vote on the MDR 2017/745 and IVDR 2017/746 transition extension proposal by the European Parliament on 16 February 2023, NSAI, welcomes the amendment in the interest of patient safety and the supply of medical devices.
Existing products have been given more time to become compliant to the MDR. Validity of MDD certificates can be extended until 2027 or 2028, depending on risk class. The administrative aspects are currently being developed by Team-NB to ensure there is a harmonised solution/approach by the various EU Notified Bodies.
Please note: NSAI cannot independently take action until this amendment is law, that is; once published in the Official Journal (OJ) of the European Union.
For certificates issued before 26 May 2021, the transition period to the new rules will be extended as follows:
For Class III devices and Class IIb implantable devices: until 31 December 2027
For Classes IIb, IIa, ls, lm, lr products: until 31 December 2028
The extension is subject to certain conditions. This means more time will only be granted for products that are safe, and for which manufacturers have already taken steps to transition to MDR. For clients transitioning with NSAI, you must submit a signed request for quotation, including the MDD products to be transitioned by 26 May 2024 at the latest, and the contract with NSAI must be signed by 26 September 2024 at the latest.
The sell-off period for existing products previously specified in MDR Art.120(4) and IVDR Art 110(4) has also been abolished, to allow product already placed on the market to be made available beyond the end date of May 2025.
NSAI welcomes the adoption of this amendment, and we look forward to the successful implementation of the regulation. However, we strongly recommend manufacturers keep progressing with their MDR transition.
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