While we are waiting for the MDR amendment to be discussed and agreed upon by the European Parliament and the Council hopefully before end May through an accelerated co-decision procedure lets try and sum up what it could mean for manufacturers of medical devices (note: As for the In Vitro Diagnostics Regulation (IVDR), which will be applicable from 26 May 2022, the commission has confirmed there will be no changes with its timeline).
Medical devices are currently regulated in Europe by Directive 93/42/EEC concerning medical devices (MDD) and Directive 90/385/EC concerning active implantable medical devices (AIMDD). Medical Device Regulation (MDR) 2017/745 was published with planned date of application (DoA) of the MDR on May 26, 2020.
Due to the COVID-19 pandemic crisis the European Commission announced and published an amendment postponing the date of application of the Medical Device Regulation 2017/745 for one year deferring application for provisions of Regulation (EU) 2017/745 that would otherwise start to apply from May 26, 2020. The Commission has stated that the delay also will “not impose new obligations on the concerned parties. It primarily aims at providing, for exceptional reasons in the context of the current COVID-19 outbreak, a one-year deferral as regards the date of application of certain provisions of that Regulation”. This includes giving the Commission the possibility to address urgent matters due to both COVID-19 and existing MDR issues by applying article 59 MDR before the DoA.
So even though the proposal is not yet approved what could the suggestion mean for the manufacturers of medical devices?
In general, the time and resources needed to transfer from MDD to MDR are huge and should not be neglected. The extra year should be used wisely. This is a proposal and not yet law. Although it is likely that the proposal will go through, it is also possible that it does not or is changed under the negotiation process.
What about clinical investigational activities under COVID-19 and now with the amendment coming?
I would strongly recommend start planning which clinical evidence is needed to support your product ongoing both under MDD and MDR. The current COVID-19 situation is having a huge impact on the conduct of clinical investigations and you will need to start putting together your clinical plans. At the moment new trials are not being accepted by Ethics Committees and Competent Authorities for review as priority is being given to any research related to COVID-19. Furthermore, almost all ongoing trials are suspended, and clinical data collection compromised due to several factors:
- Hospital study staff have been ordered to go home or have been asked to support in other clinical roles as nurses or MDs.
- New subjects are not enrolled in trials especially for trials of devices used in elective surgery which will be penalized for longer than others.
- Monitoring is not possible and remote source data verification is not allowed. Many Authorities has sent out recommendations to stop these activities to keep the resources available for the COVID-19.
- Patients are not able to go back to hospital for follow up visits due to the risk of catching COVID-19.
Therefore, the overall compliance of the investigations is at general at risk and loss of important data and most companies has put their study activities on hold.
The medical device clinical investigations are at a complete stop now and for the foreseeable future. As a result, this is going to cause a severe delay in the availability of clinical data for CE marking. I would therefore strongly recommend starting the planning and getting in line with the other activities as the competition post COVID-19 is going to be strong for the availability of patients and resources at the hospitals to provide the needed clinical evidence and data.
We are as always available here at Qmed to answer your questions regarding the MDR and how COVID-19 influences your studies. Feel free to reach out.
