In-Vitro Diagnostics

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.

Medical devices

About the Industry

The In-Vitro Diagnostics Regulation (IVDR)

It is a particularly exciting and stressful time as medical device manufacturers worldwide transition from the framework of the In-Vitro Diagnostics Directive 98/79/EC to the In-Vitro Diagnostics Regulation 2017/746/EC. As the Directive has been in place since June 14th, 1998 and was amended in 2017, this will undoubtedly be a great undertaking for medical device manufacturers, Authorized Representatives & Notified Bodies in completing this transition.

The expanded scope of the IVDR includes companion diagnostics. Classification systems has been altered to risk-based system to more closely match other international markets. All non-EU based manufacturers are obligated to appoint an Authorized Representative.

An Authorised Representative 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.

Non-EU based manufacturers are obligated to appoint a European Authorised Representative to serve as their vigilance contact point and ensure continued compliance at all times.

The role of a European Authorised Representative is both varied and challenging. The main duties include, but are not limited to, the following:

  • Providing a registered address within the European Union
  • Keeping technical documentation, EU Declaration of Conformity and CE Certificates available for inspection by the European Authorities
  • Completing registration obligations on behalf of manufacturers to EUDAMED
  • Taking care of any incident reporting
  • Representing the manufacturer towards the European Commission, Authorities and Notified Bodies
  • Safeguarding and ensuring compliance with constant regulatory updates
  • Consulting on European Regulations

Expanded responsibilities under the In-Vitro Diagnostics Regulation include:

  • Designation of Person Responsible for Regulatory Compliance (PRRC)
  • Terminate the mandate if the manufacturer acts contrary to its obligations

The currently applicable Medical Device Directive will be repealed by the Medical Device Regulation (MDR) on the 26th of May 2021. In-Vitro Diagnostics devices are regulated by the In Vitro Diagnostic Devices Directive. This Directive will be repealed by the In-Vitro Diagnostic Devices Regulation (IVDR) on the 26th of May 2022. One of the requirements set out in the MDR and IVDR is that the device needs to be registered to the European database on medical devices – EUDAMED.

EUDAMED consists of 6 modules, which are not yet fully functional:

  1. Actors registration
  2. UDI/Devices registration
  3. Notified Bodies and Certificates
  4. Clinical Investigations and performance studies
  5. Vigilance and post-market surveillance
  6. Market Surveillance

From December 2020, EUDAMED Actor registration is possible. From September 2021, second and third module of EUDAMED became active (UDI/device registration & module on Certificates and Notified Bodies). Other modules (on vigilance, clinical investigations, etc.) will be displayed later on, as soon as they are functional. Full functionality of EUDAMED is envisaged for May 2023. Until EUDAMED is functional, medical devices are still to be notified to the relevant EU Member States’ Competent Authority.

Do not forget that the UK has officially left the EU! EUDAMED Registration is not relevant for the devices that are to be placed on the UK market, however there is a mandatory registration to the UK Competent Authority MHRA. Obelis UK, as UK Responsible Person will gladly register your medical devices on the UK market!

Manufacturers shall have available within their organisation at least one personal responsible for regulatory compliance who possesses the requisite expertise in the field of in vitro diagnostic medical devices.  The requisite expertise shall be demonstrated by either of the following qualifications:

  1. a 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
  2. four years of professional experience in regulatory affairs or in quality management systems relating to in vitro diagnostic medical devices.

Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC (Micro and SMEs are those organizations which have less than 50 employees and a turnover of less than 10 million Euros) shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.

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;
  • 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 Annex XIV is issued.

Manufacturers with a registered place of business outside the Union shall designate a sole authorized representative in order to place their device on the EU market (Art 11.1).

Notified Bodies play a key role in supporting manufacturers to place only safe and compliant in-vitro diagnostic medical devices on the EU Market.  They are controlling the manufacturers by carrying out conformity assessment procedures and grant conformity certificates to in-vitro diagnostic medical devices. There are certain expectations that a Notified Body must meet before being designated by the EU Authorities.

A key aspect of their role is to audit the quality management system of the manufacturer and review the technical documentation of IVDs A, B, C, D. 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.

All  notified bodies which have been designated under Directive 98/79/EC need  to be re-designated under the IVDR. Under the IVDR, the requirements that notified bodies must meet have increased drastically. Those notified bodies are also subject to a peer review every 3 years. As a result of this process, we expect that the number of notified bodies designated under the IVDR will be very limited. Notified bodies which have been designated under the IVDR can issue the IVDR conformity assessment certificates. Manufacturer can consult the list of designated notified bodies under the IVDR in the European Commission´s directory of Notified Bodies (NANDO website).

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.

For class B and class C devices,  notified body shall draw up and keep up to date,  a sampling plan for the assessment of technical documentation as referred to in Annexes II and III covering the range of such devices covered by the manufacturer’s  application. That plan shall ensure that all devices covered by the certificate are sampled over the period of validity of the certificate.

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.

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