As an industry, we have been working hard to meet the EU Medical Device Regulation compliance deadline for some time and it has been a challenging journey for many.
The recent delay to the date of application by a full year is therefore a welcome development, especially now that businesses are facing new and extraordinary challenges owing to the global health crisis.
However, it is important to be aware of the changes that have actually been made and also what is not changing, to fully understand the scope of this recent development.
The new date of 26 May 2021 has now been approved by the European Parliament in an amendment to the original regulation.
Although it isn’t quite yet fully official, the vote to delay was approved by an overwhelming margin on 17 April 2020 and the remaining actions are a matter of parliamentary process. It must be approved by the member states and be published in the Official Journal before taking effect. It is expected to be formally enacted by 26 May 2020, the original EU MDR date of application.
The delay only applies to the Medical Device Regulation and the regulatory requirements remain the same for Medical Device Manufacturers, Notified Bodies, Authorised Representatives, Importers and Distributors. There is no change to the In Vitro Diagnostic Regulation (2017/746).
There are also other key takeaways for the industry. First, there is no change to the transition dates.
CE Mark certificates under the previous EU Medical Device Directive will still expire no later than 26 May 2024. However, Article 120 now clarifies that the transition dates also apply to Class I devices for which an assessment to the EU MDR requirements would require a notified body.
Secondly, the amendment introduces staggered implementation dates for reusable devices which bear the Unique Device Identification (UDI) carrier on the device itself.
This is a clarification welcomed by the industry, as the implementation of the UDI requirements impacts regulatory documents and product labelling. The earliest UDI date is now 26 May 2023 for implantable devices and class III devices. Class IIa and IIb devices are 26 May 2025, and Class I devices are 26 May 2027.
There are also updates to Article 59, Derogations from the conformity assessment procedures.
This pertains to exceptions to the rules for conformity assessments that allow non-CE marked products deemed of "humanitarian use" to be used for the good of public health.
The amendment also now specifically references the corresponding Articles in the MDD (Article 11.13) and AIMD (Article 9.9).
By including these references to the directives, the derogations adopted under the directives may apply or be extended using Implementing Acts once the 26 May 2021 date of application is reached. This is important in context of the efforts to get products quickly and yet safely on the market related to the global pandemic.
With this delay comes a significant opportunity for manufacturers to use this time wisely. Being ready for quality and regulatory compliance will give companies an edge over their competitors and reduce the risk of products being taken off the market.
Many businesses were struggling to fully meet the deadline and will be able to use the additional time to be fully ready, by reviewing their Clinical Evaluations and Technical File documentation, assessing Post Market Surveillance documentation, and properly evaluating Economic Operator relationships and agreements. The clarification in UDI timelines also allows for more robust planning and implementation.
