BVMed: "Important signal for patient care and MedTech companies"
The Federal Association of Medical Technology, BVMed, announced today's announcement by EU Commissioner Stella Kyriaksto suspend the entry into force of the EU Medical Devices Regulation (MDR) by one year on May 26, 2020, as an “important signal for patient care and the MedTech-Company” welcomed, so BVMed-CEO Dr. Marc Pierre moll. The BVMed expects that the European Parliament and the Council will now quickly clear the way for the MDR postponement after the Commission's initiative. "Every day counts. Because the top priority of medical device companies must be in the coming weeks and months be in the Coronavirus-Pandemic to provide all necessary products for the medical care of the population in sufficient numbers moll.
In a tweet, the EU Commissioner announced that the EU Commission intends to suspend the MDR from the start of validity by one year. A corresponding document is currently being prepared. A Commission spokesman told POLITICO that the aim of the Commission is to achieve the approval of Parliament and Council by the beginning of April.
On March 13, 2020, BVMed called for an MDR moratorium and found broad support from other associations. "This is now the signal that the industry needs," comments Möll. “Now it’s about the detail work. The medtech industry is willing to work together to work out the details and create the conditions to ensure patient care with medical devices and to implement the new regulations.”
There has recently been a lot of feedback from the BVMed membership that scientists and engineers who have been dealing with the new MDR regulations in recent years could be included in coronavirus teams. The decision of the EU Commission is important for this.
In the opinion of BVMed, the coronavirus pandemic has numerous direct effects on the preparation for the start of application of the MDR: the first notified bodies are closing or their activities are restricted. There are no more on-site audits. authorities are concerned. Companies and production facilities are also affected or have to make changes due to the pandemic. Suppliers drop out. "And this at a time when the industry is building up additional production capacities to meet the increasing demand due to the coronavirus outbreak," says Möll.
All information on the new legal framework can be found on the BVMed portal www.bvmed.de/mdr. All information on the coronavirus crisis is available in a topic portal at www.bvmed.de/corona.
The European Commission has today approved another aid scheme notified by Germany to support the German economy in the wake of the coronavirus outbreak. The scheme was approved under the Temporary Framework for State aid to support the economy in the current COVID-19 outbreak, adopted by the Commission on 2020 March 19.
Due to the worldwide spread of the corona virus, supply chains are currently partially interrupted, which leads to bottlenecks in production. In various European countries, 3D printing companies founded platforms to use additive manufacturing processes to produce missing components, for example for ventilators, and thus support medical technology companies. Open source documents - for example for the 3D printing of protective face masks - were developed, made available online and serve as the basis for component production. Last week, the European Commission called on research clusters to register their 3D printers and to participate in the production of the materials they need.