News & Events

EU MDR update

By aisltd, Thursday, 25th February 2021 | 0 comments
Filed under: Industry News.

Those who manufacture, sell, or dispense class III high risk medical products in the EU have until this May to comply with regulations outlined in the EU MDR.

The deadlines have been updated as follows:

May 2021 - Class III - high risk medical products e.g. cardiac catheters, heart valves etc. 
May 2023 - Class IIa - medium risk medical products, Class IIb - increased risk medical products.
May 2025 - Class I - low risk medical products.

More information on medical device classes:

 

 

 

 

 

 

 

 

Source: HPRA

This legislation will bring increased clarity, definition, and enhanced assessment procedures to the medical device sector.

Until the date of full application of the new regulations, devices can continue to be certified and placed on the market according to the current directives. Alternatively, manufacturers can, on a voluntary basis, certify their devices to the new Regulations in advance of the date of full application.

How do I know if my barcodes are compliant?

Verification is the measurement of the quality of a 1D barcode or 2D symbol according to an agreed-upon quality standard. Our barcode verifiers are fully-integrated off-line solutions for label testing, programmed to assess the accuracy of data encoded in 1D/2D codes against data structure specifications regulated by UDI issuing agencies (such as GS1 and HIBCC) as well as barcode print quality standards (such as ISO/IEC).

Our range of barcode verifiers automatically identify barcode types and apply the appropriate verification parameters for each symbol according to the user's selected specifications for their device. If there is an error in the format of a UDI code for example, the barcode verifier software will highlight the error for easy diagnostics.

If you wish to discuss labelling, scanning, and verifying your EU MDR/UDI code to ensure it meets the required standards, please contact us and our experienced team will be happy to help.

 

Dublin

Automatic Identification Systems Ltd

Cork

Automatic Identification Systems Ltd
Unit 35 Eastgate Drive,
Little Island, Cork,  
T45 C925, Ireland

Phone: +353 (0)21 235540
Fax: +353 (0)1 6205735
Email: info@aisltd.ie

Barcelona

AIS Vision Systems S.L
Pol. Ind. Can Roqueta,
Avda. Can Bordoll, 119 Sabadell,
Barcelona 08202, Spain

Phone: +34 931 003 035
Fax: +34 931 003 038
www.aisvision.com

Beugen

AIS-Scanology B.V. 
Laan de Wijze 20,
5835 DS Beugen
The Netherlands

Phone: +31 (0)485-561616
Fax: +31 (0)485-561610
www.scanology.nl

 

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