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 is 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. It safely stores and shares your compliance information with authorities, notified bodies, and distributors. With LICENSALE we can guide you through the complete process, review documentation and advise on how to resolve noncompliance.
All Your Representative Needs Under One Roof
Arazy Group provides expert EU Authorized Representative, UK Responsible Person and Swiss representative services using one comprehensive regulatory compliance system.
We offer meetings in English, French, Spanish & Japanese.
Arazy Group has 24 years of experience acting as an EU AR for thousands of clients. We provide exceptional services such as device-specific Technical File checklists and Gap analysis reports.
With the new MDR and IVDR changes, it is important to select the best UK REP. Arazy Group has established significant experience with the MHRA ensuring you an easy transition and continued compliance in the UK.
Swiss is a third country as of May 26, 2021. Manufacturers must designate a Swiss authorised representative to supply devices to Switzerland in accordance with the transition plan. It’s time to plan ahead and start preparing now!
Additional Regulatory Representative Information
EU Authorized Representative
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 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.
The Federal Council, the Federal Office of Public Health (FOPH) will put into force the amended Medical Devices ordinance (“Contingency MedDO”) if the Mutual Recognition Agreement between Switzerland and the European Union (EU) is not updated by this May 26, 2021 to include the Medical Device Regulation (MDR). This would result in Switzerland as a third country requiring changes and additional measures for foreign manufacturers to supply their medical and in-vitro diagnostic devices to Switzerland.
The adaptation of the Swiss medical device law is occurring in coordination with the transition periods in the EU. Manufacturers should be aware that the Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) will most likely not be updated by 26 May 2021. To prepare, manufacturers must designate an importer and a Swiss authorised representative from to supply devices to Switzerland.
According to SR812.213 (MepV) from 01. July 2020 entering into force 26. May 2021 Art. 104a the following transition period for a manufacturer which is located in the EU or EER or for a foreign manufacturer with an EU REP shall name for all products placed on the Swiss market after 26. May 2021 a Swiss AR:
- 31. Dec 2021: Class III and class IIb and active implantable medical devices:
- 31. Mar 2022: Non-implantable products class IIb and IIa
- 31. Jul 2022: Class I products, systems & procedure packs
Learn more here.
We help our clients stay in compliance.
Ready to meet with our team?
Book a meeting to get a head start!
Discuss your regulatory representative options with Arazy Group Consultants.