EU explores Coronavirus delay to medical device reforms - MDR Medical Device Regulation

Описание: EU law makers will be asked to delay the implementation of new EU medical device regulations by a year in light of the coronavirus crisis, the European Commission confirmed on Wednesday.
The move follows lobbying by representative bodies in the medical technology industry.

Commission spokesman Stefan de Keersmaecker said: "The Commission is working on a proposal to postpone the entry into force of the new Medical Devices Regulation for one year. We are working hard to submit this proposal early April and we call on [the European] Parliament and on [the] Council [of Ministers] to adopt it quickly, as the deadline for entry into force is at the end of May. This will relieve pressure from national authorities and industry and it will allow them to focus fully on urgent priorities related to the coronavirus crisis."

The EU's Medical Devices Regulation (MDR) is due to take effect from 26 May 2020, while the In-Vitro Diagnostic Devices Regulation (IVDR) will take effect from 26 May 2022. Both regulations will directly apply in EU countries and do not need to be implemented into national law.

EU Commission to postpone MDR implementation
The European Commission has announced its intention to postpone the implementation of the new Medical Device Regulation (MDR) following the Coronavirus outbreak.

It appears from what de Keersmaecker said that the Commission will only support a delay in respect of the MDR.

MedTech Europe, BVMed, which is the German Medical Technology Organisation, and the Association of British HealthTech Industries (ABHI) had all called for a delay to the reforms.

MedTech Europe said that helping healthcare systems to overcome the coronavirus outbreak "is and will be in everyone’s top priority and focus". It said: "Manufacturers are striving to keep needed medical technologies available to healthcare systems while managing the effects of the pandemic on their organisations. This severely disrupts healthcare stakeholders’ efforts to implement the [new regulations] within the fixed transition timelines."

Life sciences expert Tamsin Cornwell of Pinsent Masons, the law firm behind Out-Law, said: "The Covid-19 pandemic has, understandably, diverted resources that would otherwise have been focussed on preparing for implementation of the reforms. The necessary response to the Covid-19 pandemic, including travel restrictions, isolation and social distancing, has, and will continue to, hinder work necessary for companies to prepare. Therefore a delay to implementation should assist various parties, not least healthcare providers dealing directly with the Covid-19 pandemic."

Cornwell said: "A delay to implementation to 2021 would be after the Brexit transition period expires. This would mean the MDR and IVDR would never be in force in the UK. The UK government will need to decide whether to adopt UK legislation identical to the MDR and IVDR or have divergent legislation in some form."

Plans to supplement the MDR and IVDR with additional reforms to medical device regulations in Germany were outlined last year.

The new regulation was due to come into force on 26th May this year but in light of the pandemic, and calls from trade bodies, the Commission has confirmed it is working on a proposal to postpone the application date.

The Commission said: “With patient health and safety as a guiding principle, the Commission announced on 25 March 2020 that work on a proposal to postpone the application date of the Medical Devices Regulation (MDR) for one year is ongoing. The goal is to submit this proposal in early April so the Parliament and Council can adopt it by the end of May, its deadline for entry into force. This will take the pressure off national authorities, notified bodies, manufacturers and other actors so they can focus fully on urgent priorities related to the Coronavirus crisis.”

Trade association MedTech Europe, who called for the postponement of its implementation earlier this week, welcomed the Commission’s action, but said that a similar solution is need for In Vitro Diagnostic Regulation (IVDR) – which is due to come into force on 26 May 2022.

A statement from MedTech Europe read: “We welcome the announced intention of the European Commission to propose the postponement of the date of application for the Medical Devices Regulation by 12 months, and we also welcome the support that the European Parliament has expressed for this.

“Once adopted, this measure would enable healthcare stakeholders to maintain focus on fighting the COVID-19 pandemic while keeping healthcare systems running. Rest assured that our industry is putting all its efforts to deliver needed medical technologies to patients and healthcare professionals during these difficult weeks.