The SWIXIT Dilemma for Medtech- Part II

by Nikita Angane | May 3, 2021 | Blog, Brexit, EU, FDA, Medical Devices, MedTech

sideview of two doctors giving a patient an MRI scan

The new EU Medical Device Regulation is set to enter into force on May 26, 2021, which is less than a month away now. The Swiss Medtech is geared up with its transition plan in the event a mutual recognition agreement is not reached between the EU and Switzerland regarding the EU MDR by May 26, 2021.

The Swiss Medtech published a transition plan for medical device industry stakeholders that will be implemented if the MRA is not updated to include provisions for EU MDR. The Swiss Medical Device Ordinance provides a transition period until December 31^st, 2021 for manufacturers of class III, class IIb implantable devices, and all active implantable devices to appoint a Swiss representative. The transition period for non-implantable class IIb and class IIa devices is until March 31^st, 2022 and for class I devices the transition period runs until July 31^st, 2022.¹

The Swiss Medtech further clarifies that post the EU MDR implementation date, medical device registration will not run via EUDAMED but via the Swissmedic portal, and companies that currently have their products marketed in Swiss under the EU MDR and IVDR must plan on completing their registration in Swissmedic by November 26^th, 2021.¹

The Swiss authorized representative must have access to the product’s technical dossier or it must be provided to Swissmedic within 7 days when such a request is made. Additionally, the summary of safety and clinical performance report which is to be uploaded to the EUDAMED by the notified body must now be published by the manufacturer for public disclosure through the company’s website or other similar means.¹

While Swiss authorities realize that the transition timelines are very tight scheduled, they are still not ruling out the possibility of updates to the mutual recognition agreement with the EU MDR requirements before its implementation date. I am sure that small and medium-sized companies who are short on human and financial resources have taken the worst hit of these changes.

Whatever the changes are, rest assured that EMMA International is here to assist you with all your compliance needs, call us today at 248-987-4497 or email us at info@emmainternational.com to learn more.

¹Swiss Medtech (2021) Important contents of the Contingency MedDO (not yet passed) retrieved on 04/27/2021 from https://youregulate.com/cms-data/depot/hipwig/Brancheninformation_MDR_eMepV_EN.pdf

Nikita Angane

Solutions Delivery Specialist - Ms. Angane is a Bioengineering graduate with experience in medical device commercialization, product development, quality system compliance and regulatory affairs. Her portfolio includes working on medical devices, combination products, and pharmaceuticals. As a Solutions Delivery Specialist at EMMA International, she offers her expertise to help our clients achieve an effective and sustainable quality system, and develop regulatory strategies for market access and compliance of new products in the US and international markets. Ms. Angane earned a Bachelor of Engineering in Biomedical Engineering from the University of Mumbai, India and an M.S. in Bioengineering from University of Illinois at Chicago.