Am Donnerstag, den 2. Juli 2020 (16:00-17:00), werden zwei Senior-Experten der ISS AG aktiv am 1^st SwAPP Web-Interview über die Auswirkungen der MDR-Verschiebung auf Medtech und Pharma teilnehmen.

Diese Veranstaltung findet im Internet in Form von Präsentationen und einem Interview statt. Sandra Item, Head of Regulatory Affairs & Knowledge Management, und Bernhard Bichsel, Senior Consultant und Strategic Business Developer, geben eine kurze Einführung zu den Themen, einschließlich einer Fallstudie, und beantworten dann die brennendsten Fragen aus dem Publikum.

Weitere Informationen und Anmeldung hier.  

The COVID-19 pandemic is having a significant impact on the medical device industry, including the preparations for the upcoming implementation of the MDR.

On April 17^th the European Parliament voted in favour of the Commission’s proposal to postpone the date of application of the Medical Devices Regulation (MDR) by one year to 26 May 2021.

Today the amendment to postpone the DOA was published in the Official Journal and takes effect immediately.  

The postponement allows to prevent shortages due to regulatory reasons of already approved medical devices and make EU-wide exceptions (derogations) to the normal conformity assessment procedures for specific devices possible to ensure rapid availability of devices needed to address the COVID-19 crisis.

It also aims to give national authorities, notified bodies, manufacturers and others time to prioritise the fight against the coronavirus pandemic. Please note that the postponement does not change the fact that notified bodies decide independently until when they are accepting recertification applications under the Directives.

Medical devices may be placed on the market within the EU single market under the current European and national regulatory framework until 26th of May 2021, but manufacturers should continue their work to close existing gaps to the MDR.

The one-year delay means that the current Medical Devices Directive (MDD) and the Active Implantable Medical Devices Directive (AIMDD) will continue to apply until 26 May 2021. Swiss manufacturers do not have to fulfil third-country requirements until 26th of May 2021, as the present Mutual Recognition Agreement (MRA) between Switzerland and the European Union (EU) falls into the regulatory framework of the Directives. There is no guarantee that the MRA will be updated in time, as the crucial May 17 referendum has been called off due to the COVID-19 pandemic. The Swiss government will probably not decide on a new date before the end of May.

Source: Parliament decides to postpone new requirements for medical devices (Press Release, 17.04.2020)

Hier geht es zur Anmeldung für ein kostenloses, praxisorientiertes Webinar zum Thema PMCF vom Mittwoch, 10 Juni 2020.  

Dank der klinischen Experten unseres CRO haben wir ein kompaktes Webinar zur Methodik und Umsetzung von Post-Market Clinical Follow-up (PMCF) konzipiert und profitieren dabei von Bernhard Bichsels Einblick in den aktuellen regulatorischen Kontext der klinischen Datenerfassung!

ISS AG beteiligt sich an der Bekämpfung von SARS-CoV-2, indem wir neue Tests am Markt auf ihre regulatorische Güte und klinische Validierung prüfen. Wir unterstützen unsere Kunden in der beschleunigten Marktzulassung von lebensnotwendigen Medizinprodukten (zB. Beatmungsgeräte) oder IVD.