Seminar about new EU regulations for medical devices at Sahgrenska Science Park

The European Parliament adopted the two regulations on 5 April 2017. They will now be published in the Official Journal. Today’s medical devices and in vitro diagnostic medical devices are becoming ever more sophisticated and innovative. Existing rules date back to the 1990s and have not kept pace with scientific and technical developments in the healthcare sector. Under current rules, it’s not always possible to establish who produced devices sold in the EU, and there is a shortage of information and clinical evidence showing that they are safe and effective. Several member states have set up electronic registration tools. However, these tools are not always compatible with each other, making traceability across borders difficult. The use of different systems in different countries also place an unnecessarily heavy burden on producers who want to market a product in more than one country. Unlike pharmaceuticals, medical devices and in vitro diagnostic medical devices are not subject to pre-market authorisation. Instead, they undergo a conformity assessment to establish whether they meet the applicable standards. Depending on the risk posed by a product, the assessment may involve a so-called ‘notified body’, e.g. a laboratory, a national standards authority or the like, which performs the conformity assessment. However, the rules which determine the scope of controls carried out by these bodies vary from one country to another. In addition to improving the safety of medical devices, the draft legislation seeks to stimulate innovation. It is estimated that in 2060 there will be twice as many Europeans aged 65 or over, increasing the importance of medical devices and in vitro diagnostic medical devices for public health and medical care. The new rules will apply three years after publication as regards medical devices and five years after publication as regards in vitro diagnostic medical devices.

Read more at the European Council´s webpage>>

helenesandelinAt a seminar, arranged by Sahlgrenska Science Park and Business Region Göteborg, Helen Sandelin from Mediteq will talk about the new regultions. Register here>>

When? 20 April at 8:30-10:30
Where? Biotech Center, Arvid Wallgrens Backe 20, Göteborg