CS Lifesciences Europe supports non-EU and non-UK based manufacturers to allow them to designate CS Lifesciences Europe as their single Authorised Representative within the European Community for compliance with the MDD / IVD and coming new MDR and IVDR Regulations.
- Experienced consultants will review your Technical File/ Design Dossier, register your medical device or IVD, as required, and respond to any questions or concerns from the Competent Authorities.
UKRP – 1/1/2021
As of January 1st 2021 any non-UK based companies, intending to supply Medical Devices or IVDs into the UK market will need to appoint a UK Responsible Person (UKRP). The UKRP has obligations broadly similar to those of the Authorised Representative (EUAR) already required by the EU medical device regulations. The UKRP must be based in the UK, similarly to how an EUAR must be based in a member state of the EU.
The UKRP, who must be established in the UK, acts on behalf of a manufacturer established outside the UK to carry out specified tasks in relation to the manufacturer’s obligations. This includes registering with the MHRA before the device is placed on the UK market.
The EUAR and UKRP roles are generally similar and include:
- Declarations of Conformity/Product Registration
- Labelling and Language requirements
- Audit Support
- Incident reports, monitoring and follow-up
- Compliance
MDR Impact on UKRP/EU Authorized Representative
UKRP & European Authorized Representatives will bear more risk and obligation under Europe’s new Medical Device Regulation (MDR). They will face joint and individual liability for malfunctioning medical devices, so organisations can anticipate that both the UKRP/EUAR will monitor organization’s compliance more systematically.
Our service conforms to EU/UK guidelines MEDDEV 2.5/10 and includes:
- The legal obligations for Medical Device and IVD regulations in Europe
- Registrations for Class 1 Medical Device and General/Class A IVD devices
- Obtaining Certificates of Free Sales for contracted clients
