The new EU In Vitro Diagnostics Regulation (EU IVDR) is not radically different from the current IVD Directive (IVDD). That’s not to underestimate the amount of work that will be required to switch from the current IVDD to the new EU IVDR. Certainly, for the manufacturer who produces IVDs for the EU market today, and wants to continue supplying those devices beyond 2022, complying with the new EU IVDR will require a lot of additional work. However, very little of what is required by the new EU IVDR is completely new. Most of the new requirements are really extensions to already existing requirements. In the majority of cases the new requirements simply bring the EU regulations up to date and into line with the regulatory requirements for IVDs in the rest of the world.
Even though the current IVDD is close to being 20 years old, the European standards and MEDDEV guidance has been continuously updated. As a result, a manufacturer who is fulfilling the current MEDDEV guidance on vigilance, and the current EN standards for quality management and risk management, will find very little in the new EU IVDR that they are not already addressing.
The following topics are retained in similar form to the current IVDD;
– Essential Requirements; renamed general requirements and extended, but can still be found in Annex I. Essential requirements checklists will definitely be longer in the future.
– Technical documentation; the new requirements are clearer than before, and as with most other items, Technical Files will definitely be bigger in the future.
– Common (technical) specifications; the concept is retained where no harmonized standard exists. However, under the new EU IVDR EU reference laboratories will be established to perform the testing to those standards.
– Conformity assessment; the same concepts are retained with the manufacturer still being able to choose between different conformity routes. The choice between different levels of assessment of the quality management system, the technical documentation or product testing remains essentially unchanged.
– Registration; the requirements for registering the manufacturer are unchanged, however much more information will be required about the device in the future. Importers will also be required to register.
– Notified Bodies; the concept of Notified Bodies acting as delegates of the Health Authorities to perform pre-market assessments and routine surveillance audits is also retained, but Notified Bodies face a lot more requirements in the future and will be under a lot more supervision.
– The European database EUDAMED; the current database will be extended and in future some of the information will be publicly available.
– Vigilance; is retained with extended requirements which incorporate the content of the current Vigilance MEDDEV.
So, what is actually new in the EU IVDR?
– Classes of devices; the new IVDR segregates IVDs into four “classes”. It’s not quite as significant a change as it initially appears when one considers there are already four classes in the current IVDD; Annex II list A, Annex II list B, devices for self-testing, and others.
– Classification rules; much of the reasoning behind the IVDD’s original segregation is evident in the new rules; the current Annex II lists A and B closely resembling the new classes D and C. The really significant change is that the majority of IVDs used in clinical laboratories or in near patient testing will move from being so called “self-declared” under the IVDD, to requiring Notified Body assessment under the new IVDR.
– Post Market Surveillance (PMS); Notified Bodies will play a bigger role in supervising the manufacturer’s PMS system. Additionally, the new EU IVDR introduces a new requirement to produce a PMS Report or, depending on the device class, a Periodic Safety Update Report (PSUR). Although this is already established practice under EN ISO 14971.
– Unique Device Identification (UDI) – while UDI will be new for Europe, UDI has been an established requirement in the United States for some years already.
– Economic operators; it was clearly an omission that the IVDD didn’t include requirements for importers and distributors. The new EU IVDR corrects this omission but really only brings European importers and distributors into line with already established practices for importers and distributors of medical devices in other geographies.
That leaves only a couple of requirements in the new EU IVDR which are truly novel:
– the requirement that at least one person in the organization be formally assigned responsibility for ensuring the regulatory compliance of the enterprise (again not really new for those organizations which already have a Quality or Regulatory Compliance or Safety Manager).
– the obligation being placed on Member States to ensure persons who are offered genetic tests are informed about the significance and implications of the test and will have access to counseling.