Years of Experience
Arazy Group is one the world’s most experienced Medtech regulatory affairs firms. Our AR offices in the UK have worked closely with the MHRA since 1996 and are now acting as an UK Responsible Person for our clients. Our German and Irish offices provide EU authorized representative services to all types of medical and IVD device manufacturers.
Arazy Group operates in 140 countries worldwide. Local support will be readily available for your region, language and time zone if required in case of recalls or adverse incident reporting.
Online Technology Solution
Arazy Group’s regulatory online platform, LICENSALE, simplifies and expedites your compliance process and safely stores and shares your compliance information with authorities, notified bodies, and distributors Using LICENSALE, we will guide you through the complete process, review your documentation, and will advise you on how to resolve noncompliance.
We help our clients stay in compliance.
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Arazy Group provides expert EU Authorized Representative and UK Responsible Person services in order for you to ensure your company is in compliance with the EU MDR and UK MHRA for 2021. Get started today!
Additional EU A/R & UK Responsible Person Information
EU Authorized Representative
An EU Authorized Representative in any natural or legal person responsible for acting on the manufacturer’s behalf to assist with regulatory tasks under the manufacturer’s obligation in the EU market.
The EU Authorized Representative has the following obligations:
- Verifying that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
- Keep copies available of all documents and make them accessible to authorities on request (this includes technical documentation, declarations of conformity, and certificates, including their amendments and supplements)
- Verify that the manufacturer has registered the requested information in EUDAMED
- Cooperate with authorities on preventive and corrective actions, and inform the manufacturer immediately about complaints and authorities’ requests for samples of devices.
- Liable for defective devices together with the manufacturer, if the manufacturer has not complied with its obligations under the Regulations and is not located in the EU.
More information here.
UK Responsible Person
The UK Responsible Person will act on behalf of the manufacturer to assist with regulatory tasks under the manufacturer’s obligation in the United Kingdom. Manufacturers based outside the UK will need to designate a UK Responsible Person that is established in the UK.
The UK Responsible Person has the following obligations:
- Ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer.
- Keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA.
- In response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device.
- Forward to the manufacturer any request by the MHRA for samples, or access to a device, and ensure that the MHRA receives the samples or has been given access to the device.
- Cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices.
- Immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
- Terminate the legal relationship with the manufacturer if the manufacturer acts contrary to its obligations under these Regulations and inform the MHRA and, if applicable, the relevant notified body of that termination.
More information here.