The industry is cheering for the EU MDR delay, but the historic amendment represents a huge missed opportunity to amend the EU IVDR.On Friday, April 17, 2020, the European Parliament voted 693 votes in favor, one against, and two abstentions for the EU MDR delay. Parliament voted in favor of a one year delay for the date of entry into force of the EU MDR from May 26, 2020, to May 26, 2021. Although device companies were confident that European regulators would delay the implementation of the EU MDR, regulators repeatedly insisted that it was critical to renew the public confidence in the European device regulations. Implementation of the EU MDR would not be delayed. Then the COVID19 pandemic happened, and the EU Council and Parliament cooperated in the creation of a historic amendment to delay the implementation date.
What else was changed in this amendment?
The Commission originally proposed the delay of implementation due to the public health emergency caused by the COVID19 virus. The Council moved forward with the proposal as a first reading, and Parliament adopted the first reading with only two minor corrections. The amendment also includes an essential amendment to Article 59, “Derogation from the conformity assessment procedures.” The amendment allows the Commission to issue Implementing Acts that extend emergency measures from a single member state to the whole EU. This effectively creates an additional emergency market access mechanism under the three current directives before the EU MDR comes in to force. This could prove to be important in the current health crisis created by the coronavirus.
Manufacturers are still not out of trouble
Notified Bodies (NBs) were not anticipating a delay in the EU MDR implementation date. Therefore, NBs that had not applied for designation were expecting to no longer need to support the MDD and the AIMD after May 26, 2020. Personnel have left those NBs in many cases, and the resources to support the MDD and AIMD for another year may not be available.
NBs were refusing to quote new CE Certifications under the MDD and AIMD, because there was not enough time to complete new certifications before May 26, 2020. However, with the EU MDR delay, there is an additional year in which to process other applications for CE Certification. The question is whether NBs will have the resources to process additional applications under the current directives.
The transition deadlines for the use of inventory have not been delayed, and therefore manufacturers now have one year less of a transition from the directives to the EU MDR. Any certificates issued under the MDD and AIMD will still become invalid on May 26, 2024, because this amendment did not extend the latest date of validity for certificates issued under current directives. The NB bottleneck has also not disappeared. Any NBs that have not successfully been designated under the EU MDR by the end of this year will not be a position to significantly help alleviate the bottleneck before the delayed date of enforcement.
Why wasn’t the EU IVDR delayed along with the EU MDR delay?
Implementation of the EU IVDR is arguably in a more difficult position that the EU MDR, because there are not enough NBs that applied for designation under the EU IVDR, and the IVD industry must shift from approximately 20% requiring NB involvement to 80% requiring NB involvement by May 26, 2022. This is expected to result in a shortage of CE Marked IVD products in the EU, and the bottleneck industry has experienced for medical devices will be more severe for the IVD manufacturers. The Commission could still initiate a proposal to delay the implementation of the EU IVDR. Even, it would seem logical to take this opportunity to delay the date of both regulations coming into force at one time when there was almost unanimous support for the amendment.
The Commission’s original proposal stated, “As the coronavirus crisis increases demands for certain vital medical devices, it is crucial to avoid any further difficulties or risks of potential shortages or delays in the availability of such devices caused by capacity limitations of authorities or conformity assessment bodies related to the implementation of the Medical Devices Regulation.” This argument for delaying the EU MDR would seem to be equally valid for the EU IVDR. Also, the amendment made to Article 59 could be made to the equivalent section of the EU IVDR (i.e., Article 54). In the current crisis, the power of the Commission to expand the availability of in vitro diagnostic tests is critical. Therefore, limiting the amendment to the EU MDR seems like a huge missed opportunity.
What the EU IVDR needs that was not possible for the EU MDR delay
The EU MDR was less than 60 days from the date of enforcement when the Commission presented its proposal for the amendment to delay the EU MDR. Therefore, it was necessary to forgo formal procedures for review and approval of amendments. We have more than 750 days until the date of enforcement for the EU IVDR. Therefore, there is more time for the Commission to think carefully about any additional changes that might be desired in the fight against a global pandemic. The need for rapid market access for in vitro diagnostic tests, both molecular and serological tests, will be crucial in the coming months for identifying people with active infections and resistance to the virus. Hopefully, the Commission will watch, learn, and take preventive action in the form of an amendment to the EU IVDR.