MDR is coming on May 26, 2021. For Swiss Medtech Companies this also means a decision whether or not to prepare for a set-up with an European Representative (EAR) or not. Swiss Medtech has issued related guidance. Contact MedtechVault to find out how we can help your company to get ready for MDR.

In a recent Webinar, the role of virtual audits was assessed. Virtual or remote audits are currently one of the most relevant topics within the Medical Device Industry, especially in times of the corona pandemic (86,4 % of the companies surveyed confirm this relevance). As a result of a virtual panel discussion held with approximately ~150 participants and an accompanying survey, a common position that reflects the medical technology industry standpoint on this topic has been developed. Data...

(Swiss Medtech) On 17 April 2020, the EU Parliament adopted a proposal to postpone the date of application of the Medical Devices Regulation (MDR) by one year to the 26 May 2021. The regulation shall enter into force on the day of its publication in the Official Journal of the European Union. The postponement entails consequences also for the Swiss medical technology industry. More

See MDCG guidance how notified bodies can run audits while quarantine / travel restrictions prohibit site visits. The document clearly points out to use "the most advanced available Information and Communication Technologies as appropriate in accordance with legislation on information security and data protection". MedtechVault is the ideal tool for secure data & information exchange during Remote Audits.

German medtech trade group BVMed called for a postponement until the end of the coronavirus crisis, pointing to the effect of the outbreak on already stretched notified bodies to make its case. And one day earlier, EU notified body association Team NB warned the “outbreak is having an impact on the implementation of both [MDR and IVDR] due to travel restrictions.”

The MDR Support Panel provided some insights on the implementation of MDR with a special emphasis on the technical documentation with presentations by Bassil Akra (TÜV SÜD), Michael Maier (Medidee) and Arik Zucker (MedtechVault). Link to event page.  

The EU Parliament officially accepted the 2nd MDR corrigendum. As no request for a vote had been made on Tuesday 17 December, the text was deemed adopted. This concerns Class I products that were self-certified under MDD but now need Notified Body certification under MDR. Hence, the following Class I products that obtained MDD declaration of conformity prior to May 26, 2020 will get a 4-year transitional period until 2024: - Reusable surgical Instruments (scissors, forceps, scalpels,...) -...

MDR: some Class I medical devices will get a four-year transitional period until 2024 as per 2nd Corrigendum issued by European Council. The Corrigendum on MDR (Nov. 25, 2019) states: "By way of derogation from Article 5 of this Regulation, a device which is a class I device pursuant to Directive93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified...

From Swiss Medtech: The Medical Device Regulation (MDR) comes into effect in less than half a year. Legal uncertainty regarding the status of Swiss medical devices after 26 May 2020 remains extremely  high. It is therefore essential that you consider the current state of affairs when planning your business strategy: Update regarding the Institutional Agreement and the Mutual Recognition Agreement (MRA).    

The European Commission has confirmed that the introduction of Eudamed for MDR will be delayed by 2 years to May 2022 and will be done together with the Eudamed introduction for IVDR. It should be noted that it will not affect the MDR implementation deadline. See news for more details. Link to EUDAMED.