European Regulatory Representative Services
EU AR | UK REP | SWISS REPRESENTATIVE
Arazy Group has 25 years of EU authorized representative experience with the UK (MHRA), German (BfArM) and Irish (HPRA) competent authorities. We can guarantee your company compliance with the MDR, IVDR, Contingency MedDO and your device’s continuous placement in the EU market.
Years of Experience
Worldwide Support
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
EU AR
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.
UK REP
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 REP
PRRC
PRRC is one of the newly introduced requirements of the European Union’s MDR and IVDR. We can provide you with a skilled regulatory expert to ensure proper documentation, and successful product registration and maintenance.
Additional Regulatory Representative Information
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.
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.
Swiss Representative
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 authorized representative 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
EU IVDR in effect: As of 26 May 2022, the In Vitro Diagnostic Devices Regulation (EU 2017/746) (IVDR) applies. The commission published MDCG 2022-8, Regulation (EU) 2017/746 – application of IVDR requirements to ‘legacy devices’ and to devices placed on the market prior to 26 May 2022 in accordance with Directive 98/79/EC. In order to be placed on the market or put into service from 26 May 2022, all class A non-sterile devices and all devices not benefitting from the transitional provisions laid down in Article 110(3) IVDR, i.e. all ‘new’ devices, must be IVDR-compliant.
Swiss CHREP for IVD devices: Entry into force of the new Ordinance on In vitro Diagnostic Medical Devices (IvDO) The new legal requirements enter into force on 26 May 2022, at the same time as the application of the IVDR in the EU. The IvDO additionally stipulates various transitional periods and measures designed to ensure that Switzerland continues to be supplied with safe in vitro diagnostic medical devices and to limit the negative consequences of failure to update the MRA on surveillance.
The following timelines apply to manufacturers established in an EU/EEA state or which have an authorized representative in an EU/EEA state for designating a Swiss authorized representative.IVDR DEVICES not for self-testing – 26/05/2022
IVDD devices with EU/EEA manufacturer or EC-REP:
- Class D: 31 December 2022
- Classes C and B: 31 March 2023
- Class A: 31 July 2023
Learn more here.
Accroding to the EU MDR and EU IVDR, Manufacturers and ARs are required to have atleast one PRRC within their organization. This person will make sure the company is meeting the requirements of the MDR/IVDR and has become mandatory for MDR on 26 May 2021, and will be mandatory for IVDR as of 26 May 2022.
The PRRC has the following obligations under the MDR:
- the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
- the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
- the post-market surveillance obligations are complied with in accordance with Article 10(10);
- the reporting obligations referred to in Articles 87 to 91 are fulfilled; NOTE: This refers to Vigilance reporting, i.e. serious incident, field safety corrective action, and incident trend reporting).
- in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
The PRRC has the following obligations under the IVDR:
- the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
- the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
- the post-market surveillance obligations are complied with in accordance with Article 10(9);
- the reporting obligations referred to in Articles 82 to 86 are fulfilled;
- in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Chapter II of Annex XV is issued.
Learn more here.
We help our clients stay in compliance.
