Register here for a free hands-on webinar on Wednesday, 10 June 2020.  

Thanks to the Clinical Experts of our CRO, we have designed a compact webinar about Post-Market Clinical Follow-up (PMCF) methodology while benefiting from Bernhard Bichsel's insight into the current Regulatory context of clinical data acquisition!

ISS AG participates in the fight against SARS-CoV-2 by assessing new tests on the market for their regulatory quality and clinical validation. We support our customers in accelerating the market approval of vital medical devices (eg. ventilators) or IVD.

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)

“After 4 weeks of the training I can say that the ISS bootcamp is one of the greatest experience in my professional working life.” Serhat Daye

This pilot initiative to cope with acute shortage of Medtech experts took successfully place in March and during an intensive month of training, carefully selected boot campers received the essential knowledge to be able to work in Q or RA departments or as Product Managers with a solid Medical Device Industry Background.

The core topics of this intensive training program were the life cycle management of a medical device and of course the implementation of MDR. Part of the essence of the Bootcamp were the interdisciplinary events in which experts reflected on various aspects of the industry and shared their knowledge.

Recruiting bootcamp graduates in your company

Bootcamp graduates are now ready to put their knowledge into practice. Your benefit as a company is an accelerated onboarding of a new certified resource having a steeper learning curve than other newcomers and who can therefore immediately unfold her/his potential.

You can learn more about the available profiles and recruit a young talent for your RA/Q or Product Management department by contacting us at This email address is being protected from spambots. You need JavaScript enabled to view it.

More feedback on the Bootcamp

“Fantastic! I like the familiar ambiance and how the environment of the bootcamp is set up (…) A big enrichment for me!” - Henry Lee

“All good. Very good atmosphere. The course is intense but it should be like this.” - Corinne Ackermann

“Even if this is the first (Pilot) bootcamp, I always realised that the whole bootcamp content was created in such a professional way to teach the participants the real world with all the theoretically and practically information regarding RA and QA. Preparing daily wrap ups - real world presenters - learning games - group tasks were the highlights of the bootcamp.” - Serhat Daye

“Until the end, the atmosphere of the bootcamp was great! (…) I am happy because even after one month of lectures, the subject matter continues to be diverse and interesting.” - Sandrine Reymond

“All teachers are very engaging and motivated. They are always happy to spend more time to ensure our understanding and clarify anything that was not understood. (…) The exam was a great way for a total revision of everything we have learnt. I really appreciate the time and input the ISS members have put into organizing everything! (…) Kerryn is always there for us with a big smile to solve anything that we might need and support us through the Bootcamp! ” - Xenia Christodoulou

“I think that all teachers were very well prepared and did their best to make all topics as interesting as possible.” - Deborah Morgenthaler

“Very good, this week also had some time for the research tasks and the public speaking workshop was great to get our minds off stress!” - Sebastian De Bruyne

“I feel very good. I really like the Bootcamp so far. I feel like I have already learnt a lot and it is very challenging (…) and also the social events create a really friendly atmosphere. (…)I am very happy to have completed the MedTech Bootcamp. I learnt a lot with great teachers and great participants. I feel like it prepared me ideally for a job in MedTech.” - Claudia Solá Gutiérrez