Out-Law News | 25 Mar 2020 | 5:23 pm | 2 min. read
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.
It appears from what de Keersmaecker said that the Commission will only support a delay in respect of the MDR.
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
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.
In addition to the moratorium on MDR at European level, BVMed has called for an 'MDR emergency plan' to be prepared at national level in Germany
Munich-based Dr. Julia Traumann of Pinsent Masons said: "In addition to the moratorium on MDR at European level, BVMed has called for an 'MDR emergency plan' to be prepared at national level in Germany. This, it has said, should include making use of Article 59 of the MDR which provides for derogation from the conformity assessment procedures for the entire old-certified product range so that no supply bottlenecks arise for patients."
Traumann and colleague Marc L. Holtorf said that BVMed has also proposed a grandfathering for established medical devices for which an application for a new certification has been submitted to an MDR notified body by 26 May 2020, but which has not been processed either due to the shortfall of staff or notified bodies, or the effects of the corona crisis.
Both Traumann and Holtorf said they agreed that everything necessary needs to be done at both national and EU level to ensure that medical devices will continue to be available for patients after 26 May 2020.
Traumann said. "It has long been expected that medical device manufacturers may not be able to keep existing devices on the market because of challenges such as a lack of notified body capacity, lack of EU guidance on certain aspects of the regulation, and lack of expert panels. The corona crisis adds new and enormous challenges as many medical device manufacturers will either begin or expand production of life saving medical equipment during this crisis, and use their personal and financial resources for that purpose instead of for preparing for the implementation of the MDR."
25 Mar 2020
25 Mar 2020