The EU IVDR Regulation – An Overview – Part I

The PIP breast implant scandal brought to light weaknesses in the overall regulatory process to control IVDs.

It may include –

  • The certification system by Notified Bodies (NBs),
  • The need for risk-based classification
  • and more clinical evidence through the device lifecycle.

Thus, to better align with international guidelines. The European Union’s IVDR 2017/746) replaces the current IVDD 98/79/EC, willfully apply from May 2022.

Since, at present, a majority of IVDs are self-certified. The IVD industry will change once the risk-based classification system comes and greater NB oversight is enforced.

In contrast to the EU MDR, the scope of the IVDR includes diagnostic and monitoring devices. That may attach to a person but are specifically used for monitoring human functions.

IVDs span from a blood collection tube or a pregnancy test, glucose & cholesterol tests, to a multipurpose analyzer intended for hospital laboratories.

It is interesting to note that while the IVDR affects a smaller product range, it has a more extended implementation period.

Regulation (EU) 2017/746

Regulation 2017/746 (IDD) is a Regulation of the European Union relating to the commercialization and the use of In vitro diagnostic medical devices.

Changes compared to IVDD included changes in device classifications, stricter inspection for manufacturers by Notified Bodies introduced new the Person responsible for regulatory compliance (PRRC) a requirement governing the.

The regulation came in April 2017.

The regulation introduces the classification of IVD in the risk classes like A, B, C, and D.There are seven classification rules given in Annex III.

MDGC guidance 2020-16 gives the classification of classification rules with classification examples. Only devices in the lowest risk class are excluded from the requirement of the notified body.

Some of the significant changes to consider in the EU IVDR are:

  • Increased regulatory oversight,
  • Expanded clinical evidence requirements
  • More effective provisions for IVD manufacturers
  • Intensified supervision of Notified Bodies.

What’s new in EU IVDR?

Risk-based classification with greater NB oversight

The IVDR identifies four risk classes:

  • The Class A (lowest risk),
  • Class B,
  • and Class C,
  • and Class D (highest risk),

All purposes must be classified for devices with multiple intended purposes, and the highest risk class is applicable.

Class B, C, and D IVDs will require NB intervention as a part of their conformity assessment, adding to the burden on NBs, who already had extra work due to the MDR.

Interestingly, the manufacturer is responsible for classifying a device, not the Notified Body or Competent Authority.

Following Article 47, if a manufacturer and Notified Body cannot agree on the classification, the Competent Authority will make the final determination.

Unlike the IVDD, the IVDR encourages a shift from the pre-approval stage (i.e., the path to CE Marking) to a life-cycle approach, similar to the life-cycle view advocated by the US Food and Drug Administration and many international standards.

Incorporating European guidance (MEDDEVs) into the regulation, some concepts that were not previously applicable to IVDs, demonstrate the life-cycle approach, namely: Borderline and Classification issues, Authorized Representation, Performance Evaluation, Vigilance, and Post-Market Performance Follow-Up.

The IVDR will bring about a stricter, two-fold regimen of supervision. More rigorous surveillance by Notified Bodies will reduce risks from unsafe devices and greater scrutiny of NBs themselves. As a result, the requirements for qualified NB staff have increased considerably.

Expanded Product Scope

IVDs will now include Genetic testing and diagnostic services, including stand-alone software, such as mobile medical apps, which may now be considered IVDs in line with the interpretation in MEDDEV 2.1/6.

Self-testing devices have been redefined, and additionally, the concept of single-use devices intended to be used during a single procedure, which was part of the MDD, has been introduced in the IVDR.

The IVDR also introduces the concept of companion diagnostics, kits, and new rules for in-house tests, which will be detailed in the following article.

Will the IVDR improve the quality, safety, and reliable regulation of IVDs?

The revised IVDR proposes clarifying obligations for companies involving IVD manufactures and suppliers. The priority of traceabilization throughout the whole supply chain has been increased.

New clinical evidence standards are being made available on the European Databank of medical devices.

Further vigilance reporting requirements for monitoring post-market drugs will be more stringent, aligning the regulation of VDs with those of medicines in the EU.

The legislation’s goals to resolve regulatory problems include addressing an increasingly digital approach to health, including algorithms and software applications and increasingly technological approaches to healthcare.

Greater Importance of Technical Documentation & Conformity

Manufacturers are now required to supply the appropriate Competent Authorities (CA) with all information necessary to show conformity.

Further authorizing them to share that information with patients or their representatives claiming compensation.

The manufacturer is required to provide full Disclosure on Design, Production, and Quality Testing.

There are certain rules that a manufacturer should follow:

  1. Preparing technical documentation before placing the device in the market
  2. Ensuring that the technical documentation is available to the market surveillance authorities
  3. Preparing the technical documentation for 10 years from the date the product is placed in the market.

Identification of ‘person responsible for regulatory compliance.’

It remains to be seen what the scope of the role mentioned above will be, post enforcement of the IVDR.

As the Authorized Representative is made jointly culpable for defective devices.

The non-European manufacturers may face higher costs and more complex processes to enter the European market than their European counterparts.

Unique device identification (UDI) for improved traceability

The primary device identifier (Basic UDI-DI) must refer to in an IVD’s Declaration of Conformity and on the certificates of Class B, C, and D devices.

No “grandfathering” provisions  

Regardless of prior approvals, recertification is mandatory for all currently approved in vitro diagnostic devices adhering to the new requirements.

More Stringent Requirements for Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF)

The IVDR introduces clinical evidence and post-market performance follow-ups as new concepts for IVDs. Performance evaluation is an ongoing process. That evaluates the device during its life cycle with clinical evidence to support the intended purpose.

It is in the solid post-market performance evaluation plan. It will ensure the identification of outdated and under-performing devices for noncompliance, which may stimulate innovation.   

What this means for the Industry:

With more comprehensive laws governing the regulation and delimiting the scope of IVDs than its predecessor, the IVDR may lead to an entirely new infrastructure for innovation in the field of IVDs in the European Union.

Although some experts predict that the increased requirements for current clinical performance data may discourage developing innovative tests for rare conditions, institutions were further will have a clear role in managing and safeguarding their in-house tests.

It is awaiting that this new approach will also affect staffing at Competent Authorities, NBs, and the EOs, manufacturers included.

The IVDR stresses the importance of establishing device performance through Technical Documentation, Clinical Performance, Scientific Validity, and Analytical performance.

Make sure Technical Documentation does not end with a submission. It requires updations throughout the device lifecycle.

Finally, the classification of a device can influence the documentation. Manufacturers should mindfully work on classification rules to classify products accurately and efficiently.

Thus, the IVDR will introduce significant changes to European regulatory requirements for IVD devices. It will require a more comprehensive approach, ranging from IVD development to market surveillance to end usage.

Greater emphasis on risk management strategies and PMCF will ensure greater accuracy of claims and safety of devices.

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