Industry Experts with a transparent approach to EU Medical Device Registration Compliance.     

Medical Device Regulation Assistance

EME Disability Aids provides the role of an Authorised Representative (AR) with respect to placing Class 1 Medical Devices into the EU market place as defined within the EU Medical Device legislation.


The role of the Authorised Representative (AR) that EME Disability Aids provide is to act as a liaison between contracted manufacturers outside of the EU and the relevant Competent Authorities. 


  • Administration taken care of

    EME Disability Aids will perform tasks on your behalf, which may include review of technical documentation, product registration, incident reporting, notifications of change to competent authorities, regulatory updates, and more.

  • Legal Compliance

    EME Disability Aids will also be able to obtain Certificates of Free Sale (CFS) for your Class 1 medical devices that can be required by governmental health agencies, demonstrating your product is legally enabled to place on the EU market.

  • Working with Manufacturers

    The Directives/Regulations require the AR to have access to the manufacturer's Technical Documentation, ISO 14971 Risk Assessment and Testing documentation. 

Class 1 Medical Devices

Support for all of the below EU CE Regulations

Medical Devices Regulation (MDR) – (EU) 2017/745

Restriction of Hazardous Substances Directive (RoHS) – 2011/65/EU

Medical Devices Directive (MDD) – 93/42/EEC
Low Voltage Directive (LVD) – 2014/35/EU
Electromagnetic Compatibility Directive (EMC) – 2014/30/EU

When do these new regulations begin?

With our help, ensure your Medical Device Business is compliant by 26 May 2021.

Enquire

+353 1 695 0067

Century House, Harold's Cross Road,

Dublin 6w P993, Republic of Ireland