Delay to implementation of the Medical Devices Regulation

What are the implications of the postponement of the date of application?

The Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) were published in the Official Journal of the European Union on 5 May 2017. Publication in the Official Journal set the key dates in the implementation timetable. The regulations entered into force on 25 May 2017 – that is when the regulations came into effect and the transition period started. The transition period for the MDR was set as three years. The transition period of the MDR was due to end on the date of application, that was 26 May 2020.

The first official indication of a delay in this timetable came when a spokesperson for the European Commission on health, food safety and transport indicated that the Commission wanted to postpone the MDR for one year, i.e. until 26 May 2021. In the statement, the spokesperson actually referred to postponement of the entry into force of the MDR. However, this happened in May 2017. It seemed reasonable to presume that postponing the date of application of the MDR was what is intended. The Commission proposal to Member States in the European Council and the European Parliament for an amending regulation was, as expected, postponing the date of application. The approved text was published on 24 April 2020.

As well as postponing the date of application of the MDR, the amending regulation also delays or extends, as applicable, dates or deadlines for:

• repeal of the Active Implantable Medical Devices Directive (AIMD) and Medical Devices Directive (MDD)
• drawing up a declaration of conformity under the MDD for a class I device requiring notified body involvement under the MDR
• availability of the common specification of products without an intended medical purpose
• availability of the common specification for reprocessing of single use devices
• publication of the notice on the functionality of the Eudamed database
• Member States publishing their rules on penalties for infringements of the MDR
• permission to designate notified bodies to the MDR whilst the AIMD and MDD remain in force
• clinical investigations to be subject to MDR requirements
• publication of guidance on the operation of expert panels established under the MDR

The amending regulation also brings forward the provisions in the MDR for the Commission to extend the validity of a national derogation to the conformity assessment requirements in exceptional cases. This allows for national derogations in the interest of protection of health or safety to be applied across the European Union for a limited period of time.

It is important to note that the dates were not changed for:

• the period of continued validity of certificates or declarations of conformity to the MDD or AIMD
• the deadlines for application of unique device identification (UDI), and for the UDI to be included on the device itself

Furthermore, implications for deadlines for harmonization of standards in the Standardisation Request from the Commission to the European Standards Organizations are not covered.

The amending regulation does not mention the IVDR. The date of application of the IVDR is not changed in this amending regulation. For the IVDR, the transition period is five years and so the date of application for the IVDR, and the end of its transition period, is 25 May 2022.

Postponement of the date of application of the MDR provides some respite to all those manufacturers, notified bodies and competent authorities trying to deal with the demands of the COVID-19 pandemic. Manufacturers have an opportunity to look at the timelines in their MDR implementation plans. But, given that the deadlines for continued validly of certificates or declarations of conformity to the Directives and UDI  have not changed, the effective end date for many transition plans are not altered. Manufacturers certainly should not put their plans onto the back burner; manufacturers need to ensure they keep progressing the transitions plans, including discussions with their notified body, in order to ensure alignment on timings for submissions, certifications, audits etc in order to meet the deadlines.

Author: Eamonn Hoxey, of E V Hoxey Ltd, UK, is a writer, trainer and consultant on a range of life science areas including regulatory compliance, quality management, sterility assurance and standards development