EU: The Latest Update on Implementation of IVDR and MDR

The Medical Devices Regulation 2017/745 (" MDR") and the In Vitro Diagnostic Devices Regulation 2017,/746 (" IVR ") are significant developments and strengthen the existing regulatory system in Europe for medical devices. The new Regulations update the EU regulat

The Medical Devices Regulation 2017/745 (" MDR") and the In Vitro Diagnostic Devices Regulation 2017,/746 (" IVR ") are significant developments and strengthen the existing regulatory system in Europe for medical devices. They replace the original Directives that have been in effect for more than 25 years. The new Regulations update the EU regulatory framework for medical devices, improving clinical safety, traceability, and market access for all producers.

The Regulations are subject to a transitional and staggered implementation. Original MDR provided a 3-year transition period, with full application starting in 2020. However, due to the global epidemic of COVID-19, the MDR's full application had been extended to May 26, 2021. As described below, the IVDR will be further delayed. We will update you on the MDR and IVDR implementations in this article.

 

In Vitro Diagnostic Devices Regulation

EU Authorities stated that the COVID-19 pandemic had confirmed the need to have a strong regulatory framework for in vitro diagnostic medical equipment in the EU. This ensures that all EU-market tests are reliable, accurate, and safe. Around 70% of clinical decisions are made within Vitro diagnostic devices, such as HIV and pregnancy tests or SARS-CoV-2 testing. The associated public health crisis has created additional and unimaginable challenges for IVDR implementation. Recent proposals by the European Commission to delay IVDR implementation due to extraordinary circumstances such as the COVID-19 pandemic. This is to avoid a "significant disruption of the supply of IVD devices in the market for both health institutions Dand Vthe public.

 

The Proposal introduces a tailored transitional period for devices that must undergo a conformity evaluation involving notified entities for the first time under IVDR. The Proposal extends the transitional period for devices covered under the in vitro medical devices Directive (" Directive98/79/EC") by 1 year, to May 26 2025. The length of these transitional periods will vary depending on the device's risk class. The transition period for lower-risk devices, such as class B and A sterile devices, will be extended until May 26 2027. However, higher-risk devices (class C and D) will transition from May 26 2025 to May 26 2026.

Manufacturers will need to adapt to some aspects of IVDR in the next year, including increased market surveillance and vigilance requirements, even though their products are not subject to an extended transition period.

 

Notified Body Shortage

According to the Proposal, the lack of an independent conformity assessment body (" Notified Body") was identified as one of the major roadblocks to the implementation of the IVDR. Only a small percentage of high-risk devices (about 8%) are currently subject to Notified Body Control under Directive 98/79/EC4. IVDR will place around 80% of in-vitro diagnostic medical equipment under the control and supervision of Notified Bodies. This is the majority of them for their first time. Before placing their devices on the market, manufacturers will need to apply for a Notified Body to obtain one or more certificates. A conformity assessment process takes approximately 1 year. After that, additional time (around 6 months) is required to produce the devices and prepare them to release in the market.

Ireland's Notified Bodies, the National Standards Authority of Ireland, is currently seeking designation under the IVDR. Particularly, only six Notified Bodies are designated under IVDR (established only in three countries, France and the Netherlands). This makes it difficult for manufacturers to perform the legally required conformity assessments procedures on time.

The Council of the European Union approved the Proposal in its first reading, December 2021. The Regulation will be published in the Official Journal of the European Union and will become effective immediately.

 

(Related – Medical Devices Regulatory Changes 2021 )

 

Medical Devices Regulation

After, the global COVID-19 epidemic forced the MDR to be delayed for one year. Here year transition period; the MDR was to be fully effective on May 26 2020. The global effective on May 26th 2021.

 

Classification and conformity assessment

Before any medical device can be placed on the EU markets, it must have a CE mark. Medical device manufacturers must demonstrate that their devices meet the requirements of MDR/IVDR by conducting conformity assessments proportional to their risk class.

The manufacturer declares compliance with the legislation for class I medical devices. For general category IVDs, CE marks the medical device/IVD (self-declaration). Active implantable medical devices of classes IIa, IIb, and III must be submitted to a Notified Body. The Notified Body will then evaluate the conformity of the device and issue a CE certificate if it meets the requirements of the Regulation.

 

To assist manufacturers in applying the MDR's classification system, the Medical Device Coordination Group (the MDCG), which publishes guidance documents,  (the MDCG Guide). This guidance will give industry and Notified Bodies additional information about applying the 22 rules of classification in MDR. It will also promote greater harmonization within this system.

The HPRA in Ireland is currently developing borderline classification guidance to complement and accompany the MDCG guidance.

 

Exemption from the conformity evaluation procedures

Manufacturers who are unable or unwilling to undergo conformity assessments or obtain a CE certificate of a Notified Body can rely on the regulatory exemption under Article 59 MDR. This exemption allows Member States to authorize the supply and use of medical devices in their territories without a CE marking in the public's interest or for patient safety or health. The European Commission may also extend the EU Member State's decision to the whole EU market in "extraordinary circumstances" and only for a short time. Although this new mechanism is only available in exceptional circumstances, it can significantly reduce manufacturers who have operations throughout the EU.

Many EU Member States have adopted exemptions from CE marking requirements following the publication of the Commission Recommendation, March 13, 2020O and  Guidelines for the adoption of Union-wide derogations regarding medical devices in accordance Article 59 of MDR. The COVID-19 guidance has been released by the Italian, Dutch, Belgian, and Belgium national competent authorities.

 

Due to the ongoing COVID-19 pandemic and continuing supply chain constraints, EU medical device manufacturers are difficult. Many manufacturers who may have difficulty complying with current conditions will welcome the Proposal to delay the IVDR. Manufacturers of medical devices regulated under the MDR may still use Article 59's derogation exemption, which is a relief for patients, hospitals, and EU manufacturers.

 

 


Sara Williams

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