The Medical Devices Regulation 2017/745 (“MDR”) and the In Vitro Diagnostic Devices Regulation 2017/746 (“IVDR”) represent a significant development and strengthening of the existing regulatory system for medical devices in Europe and replace the original Directives which have been in place for over 25 years. The new Regulations overhaul the EU regulatory framework for medical devices, improving clinical safety, traceability and market access for all manufacturers.

The Regulations have a staggered implementation / transitional period. The MDR originally provided for a three-year transition period with full application from 2020, however due to the global outbreak of COVID-19, full application of the MDR has been extended to 26 May 2021. The IVDR will be further delayed as described below. In this article, we will provide an update on the implementation of MDR and IVDR.

In Vitro Diagnostic Devices Regulation

EU Authorities have stated that the COVID-19 pandemic has confirmed the need for a robust regulatory framework for in vitro diagnostic medical devices in the EU, in particular to ensure that all tests placed on the EU market are accurate, reliable and safe. It is estimated that around 70% of clinical decisions are made using in vitro diagnostic medical devices such as HIV tests, pregnancy tests and SARS-CoV-2 tests. At the same time, the associated public health crisis has also given rise to additional and unprecedented challenges for the implementation of IVDR. The European Commission has therefore recently proposed to delay the implementation of IVDR due to the extraordinary circumstances created by the COVID-19 pandemic and the resulting delay in the designation and work of notified bodies under the IVDR to avert a “significant disruption in the supply of in vitro diagnostic medical devices on the market both for health institutions and for the public” (the “Proposal”)[1].

It is proposed to extend the existing transitional period for devices covered by a valid certificate issued under the current in vitro diagnostic medical devices Directive (“Directive 98/79/EC”) by one year until 26 May 2025. The Proposal also introduces tailored transitional periods for devices that have to undergo a conformity assessment involving notified bodies for the first time under the IVDR. For these devices, the length of the transitional period will depend on the risk class of the device concerned. Lower risk devices such as class B and class A sterile devices will benefit from a transition period until 26 May 2027, whereas higher risk devices (class D and class C devices) will only have a transition period until, respectively, 26 May 2025 and 26 May 2026.

Manufacturers will still be required to adjust to certain aspects of IVDR next year, such as the enhanced requirements for vigilance and market surveillance, even if their products are otherwise subject to the extended transition period.

Notified Body shortage

The Proposal identified the shortage of independent conformity assessment bodies (“Notified Bodies”) as one of the main roadblocks to the implementation of the IVDR. Currently, only a relatively small number of high-risk devices (about 8% of all in vitro diagnostics on the market) is subject to Notified Body control under Directive 98/79/EC4. Under IVDR, around 80% of in vitro diagnostic medical devices will be under the control of Notified Bodies, the vast majority of them for the first time. That means that manufacturers will need to apply to a Notified Body and obtain one or more certificates after completion of the appropriate conformity assessment procedure, before being able to place their devices on the market. On average, a conformity assessment procedure takes around 1 year, after which additional time (around 6 months) is needed to produce the devices and prepare them for release on the market.

In particular, with only six Notified Bodies designated so far under IVDR (established in only three countries – Germany, France and the Netherlands), there is “a grave shortage of notified body capacity, making it impossible for manufacturers to conduct the legally required conformity assessment procedures in time”[2]. Ireland’s Notified Body, the National Standards Authority of Ireland, is currently pursuing designation under the IVDR.

The Proposal was approved by the Council of the European Union at first reading in December, 2021 and the Regulation will enter into force as a matter of urgency on the day of its publication in the Official Journal of the European Union.

Medical Devices Regulation

The MDR was due to become fully applicable on 26 May 2020 after a three-year transition period. Due to the global outbreak of COVID-19, full application of the MDR was postponed for a year and became fully applicable on 26 May 2021.

Classification of medical devices and conformity assessments

All medical devices must be CE marked before being placed on the EU market. Manufacturers of medical devices are required to demonstrate that their medical device meets the relevant requirements of MDR and IVDR through conducting conformity assessments which are proportional to the risk class of their device.

For class I medical devices and general category IVDs, the manufacturer declares conformity with the legislation and CE marks the medical device / IVD (self-declaration of compliance). For active implantable medical devices, class IIa, IIb and III devices, sterile devices, devices with a measuring function, self-test IVDs and for IVDs listed in Annex II of Directive 98/79/EC, in order to be CE marked, a manufacturer must submit an application to a Notified Body who then assesses the conformity of the device and issues the manufacturer with a CE certificate if the device meets all of the necessary requirements of the relevant Regulation.

The Medical Device Coordination Group (the “MDCG”), which publishes guidance documents to assist stakeholders in implementing the MDR, recently published its Opens in new windowGuidance on Classification of Medical Devices (the “MDCG Guidance”) to support manufacturers in the practical application of the MDR’s classification system. The guidance will provide additional clarity to the industry and Notified Bodies on the application of the 22 rules of classification outlined in MDR, and will help promote greater harmonisation within the system.

In Ireland, the HPRA is developing borderline classification guidance that will accompany and complement the MDCG Guidance.

Derogation from the conformity assessment procedures

As emphasised in the Proposal there is currently “a grave shortage of notified body capacity, making it impossible for manufacturers to conduct the legally required conformity assessment procedures in time”[3].

Manufacturers that are unable to complete conformity assessments and obtain a CE certificate from a Notified Body are relying on the regulatory derogation exemption provided for in Article 59 of the MDR. The exemption allows individual Member States to authorize the supply and use of medical devices without a CE mark in their respective territories in the interest of public health, or patient safety or health. The European Commission can also, in “exceptional circumstances” and for a limited period of time, extend the EU Member States’ decision to the entire EU market. This new mechanism, while applied only in exceptional circumstances, can substantially lessen the burden for manufacturers with operations across the EU.

Several EU Member States have already adopted national exemptions from CE mark requirements due to COVID-19, following the publication of the Opens in new windowCommission’s Recommendation of March 13, 2020 and Opens in new windowGuidelines on the adoption of Union-wide derogations for medical devices in accordance with Article 59 of the MDR. National competent authorities from Ireland, Netherlands, Belgium and Italy have adopted national exemptions due to COVID-19 (or released guidance) to date.

The protracted COVID-19 pandemic and ongoing supply chain constraints have left EU medical device manufacturers in a precarious position. The proposal to postpone the application of the IVDR is a welcome development to many manufacturers that may struggle to achieve compliance in the current climate. In the meantime, manufacturers of medical devices regulated under the MDR can rely on the derogation exemption in Article 59, which provides a lifeline to EU manufacturers, hospitals and patients.