The EU’s proposed extension for IVD medical devices aims to prevent shortages. Manufacturers must prepare by meeting IVDR requirements promptly.
In preparing to export your in-vitro diagnostic products to the EU market, it is important to determine whether or not your products will fall under the scope of ‘in-vitro diagnostics’ according to this specific legislation in the EU market.
If they do qualify, you will also need to determine the appropriate classification in order to determine your unique path to compliance.
According to the IVDR, all non-EU based manufacturers are obligated to appoint an Authorised Representative within the Union.
The In-Vitro Diagnostics Regulation (IVDR)
The In-Vitro Diagnostics Medical Devices Regulation 2017/746 (IVDR) applies since May 26, 2022. The IVDR introduces new obligations for economic operators, strengthens market surveillance and traceability, and classifies IVDs according to a new classification system. IVD medical devices can be classified in four different classes (A, B, C, and D), from A being the lowest to D being the highest risk class. There are also seven risk-based classification rules. The expanded scope of the IVDR includes companion diagnostics as well.
Non-EU based manufacturers are legally obligated to appoint an Authorised Representative (EC REP) in order for their products to legally circulate within the EU Market.
The Authorised Representative acts as manufacturer’s vigilance contact point and ensures continued compliance.
EC-REP is any person naturally or legally established in the Union who is explicitly designated by the manufacturer to act on their behalf. This person may be addressed by authorities and bodies within the Community, instead of the manufacturer themselves, with regards to the requirements of this Regulation.
The main tasks of the authorised representative include, among others, the following:
- To verify that the technical documentation and other essential documents have been drawn-up.
- To verify that the manufacturer has complied with his registration obligations.
- To provide the competent authority with all the information and documentation necessary to demonstrate the conformity of a device.
- To forward to the manufacturer any request by its competent authority for device sample.
- To cooperate with the competent authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices.
- To inform the manufacturer about complaints and reports about suspected incidents related to a device for which they have been designated.
The EC-REP or EAR (European Authorised Representative) is jointly responsible for defective products and must terminate the contract with the manufacturer in case the manufacturer acts in a way that conflicts with their obligations. Consequently, the EAR is liable for defective products when the manufacturer has not complied with its obligations under IVDR.
Actors and devices need to be registered in EUDAMED, the European Database of Medical Devices.
One of the requirements set out in the IVDR is the registration in the European Database of Medical Devices, EUDAMED. The registration is mandatory from the moment the European Commission announces that the database is fully functional. Economic operators will have following deadlines to register:
- Within 6 months for actor registration
- Within 24 months for device registration
- Immediately in case of incidents
EUDAMED consists of 6 modules:
- Actor registration
- UDI/Devices registration
- Notified Bodies and Certificates
- Clinical Investigations and performance studies
- Vigilance and post-market surveillance
- Market Surveillance
The aim of EUDAMED is to improve market surveillance, improve devices’ traceability and strengthen transparency. The economic operators that must register are manufacturers, authorised representatives, and importers.
Manufacturers as well as authorised representative must have available within their organisation at least one person responsible for regulatory compliance (PRRC) who has the following qualification:
- Diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices or
- Four years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.
Micro and small enterprises can outsource their PRRC, whereas other enterprises must appoint a PRRC within their organisation.
The person responsible for regulatory compliance shall at least be responsible for ensuring that:
- 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.
- Post-market surveillance obligations are carried out with in accordance with Article 10.
- Reporting obligations referred to in Articles 82 to 86 are fulfilled.
- In 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 Annex XIV is issued.
These play a key role in supporting manufacturers to place only safe and compliant in-vitro diagnostics on the EU Market. They are assessing the manufacturers by carrying out conformity assessment procedures and grant conformity certificates to in-vitro diagnostics.
Notified bodies (NBs) are third-party conformity assessment bodies that carry out conformity assessment procedures and eventually issue conformity certificates. Only those NBs that are listed on NANDO website can issue the necessary certificates.
IVD medical devices of classes A in sterile condition, B, C, and D must be subject to a conformity assessment procedure by a notified body.
A key aspect of their role is to audit the quality management system of the manufacturer and review the technical documentation. Notified bodies will issue EU Technical Documentation Assessment Certificates, EU Quality Management System Certificate, EU Production Quality Assurance Certificate and EU Type Examination Certificates depending on the conformity assessment procedure selected.
Notified bodies shall conduct surveillance audits on at least an annual basis as well as unannounced audits of manufacturer and where applicable of subcontractors and suppliers.
Manufacturers of Class A IVDs can self-declare the conformity of their devices and do not need to involve a notified body.
Did you know that as of May 2022, as an importer or distributor of in-vitro diagnostics devices, you have the legal obligation to ensure that the devices you are making available on the EU market comply with the IVDR?
By distributing or importing in-vitro diagnostics from manufacturers based outside the European Union, you must add your company details, review labels, CE Certificate, declaration of conformity, UDI codes, keep a register of complaints, of non-conforming devices and of recalls and withdrawals and more.
As Authorized Representative for the manufacturer, Obelis will:
- Verify that a QMS is in place and will ensure that technical documentation has been draw up according to IVDR annex II an II and appropriate conformity assessment procedure has been performed.
- Provide a vigilance contact point.
- Store the product technical documentation for over 10 years.
- Verify EUDAMED device registration.
- Validate the manufacturer’s registrations on the EUDAMED portal.
- Work directly with the manufacturer at no costs to you as importer.