Blog

Checklist for a Secure Remote Audit

Recommended measures for your video conferencing system Use a registered account (not a free service) Make sure of latest software version Protect all meetings with a password Chose a service with a “waiting room” option, check-in all participants prior to start & banish intruders After start block meeting to prevent further access Restrict access rights to protect screen sharing against misuse Requirements for secure document / information exchange Use a system with an easy to use...

read more

MDR introduction postponed to May 26, 2021

(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

read more

Remote Audits allowed by EU Commission

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.

read more

Remote Audits for Medical Device Manufacturers: protect your sensitive Data & Trade Secrets!

Medical device manufacturers must grant access of highly sensitive data and information to Notified Bodies during Remote Audits. Although such information is never meant to leave the manufacturer’s site it is often shared via common cloud services, especially in times of travel restrictions. How can transfer of sensitive information be established to securely conduct a Remote Audit? by Arik Zucker (az) · In times of travel restrictions due to the recent COVID-19 outbreak, Notified Bodies have...

read more

MDR introduction delayed in the light of the COVID-19 pandemic?

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.”

read more

Need help with your European Authorized Representative?

How do you secure your sensitive & confidential Technical Documentation while giving it out of hands, e.g. to your European Authorized Representative? Here’s the solution: MedtechVault is a highly secure platform to make your Technical Documentation available to your Authorized Representative (AR) and other Economic Operators while providing best possible protection. Also, it enables proven efficiency gain – not only when dealing with your AR! Plus, it’s MDR compliant!    

read more

MDR – 4-year transitional period for certain Class I devices

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,...) -...

read more

Four-year transitional period until 2024

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...

read more

Update by Swiss Medtech regarding the MRA

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).    

read more

Implementation of Eudamed for MDR delayed by 2 years

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.

read more

Dekra Certification for IVDR

After having obtained designation for MDR as third Notified Body (after BSI Assurance UK Ltd and TÜV SÜD Product Service GmbH), DEKRA is now the first IVDR Notified Body. Congratulations!  MedtechVault can help your company to better manage your communication with your notified body.

read more

Classifying Software Under MDR, IVDR

The European Commission’s Medical Device Coordination Group (MDCG) on Friday released guidance to help medical software manufacturers understand the criteria for the qualification of software under the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Read the full article. About RAPS. Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 – MDR and Regulation (EU) 2017/746 – IVDR (pdf).

read more