The medical devices industry is in a state of flux: The new Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostics Regulation (EU) 2017/746 pose major challenges for notified bodies, manufacturers and other economic operators. From 2020 (MDR) and 2022 (IVDR), CE marks can only be issued in accordance with these regulations. This also affects other international markets, which either require the CE mark or allow simplified market access with the CE mark. Further political hurdles make this even more difficult. In these times of uncertainty, it is even more important to have a strong expert with good net-working and years of experience advising on regulatory affairs.
Approval in the European Economic Area
For approval in the European Economic Area, manufacturers must undergo a conformity assessment procedure for their medical devices. It is essential that each medical device meets the applicable basic safety and performance requirements according to Annex I of the Regulation (EU) 2017/745 on medical devices. Also, Regulation (EU) 2017/746 on in vitro diagnostic medical devices applies with a time delay compared to the medical device regulation and now requires way more manufacturers to undergo an approval process involving a notified body.
Approval in the USA
The U.S. market is an attractive market for the medical technology industry. However, the American approval system differs significantly from the European one: Among other things, there are product classification codes and individual risk classifications of medical products. The U.S. regulatory authority FDA (Food and Drug Administration) has decision-making sovereignty.
Each American product classification has a corresponding, U.S.-specific approval process. Our experts can provide active support to help you navigate the complex American approval system.
How We Can Help
We work with you to find the easiest and most efficient path for approval of your medical devices in the USA. In the area of regulatory affairs we advise you in all regulatory questions in order to classify your products in the right device category (also in the borderline area), to quickly bring them into the desired markets and to take the regulatory legal framework into account to maintain product documentation and the regulatory status of your products.
With our subsidiary PROSYSTEM Consulting Schweiz AG, we can offer you an extensive portfolio of local services. You can also benefit from our many years of experience in the field of regulatory affairs and our expertise in the locally applicable approval processes for the international approval of medical devices, for example on the Asian, Brazilian and Canadian markets.
For further details on regulatory affairs or for a non-binding offer, please contact us. Take the opportunity to attend one of our seminars or book an in-house training tailored to your needs, such as approval in the Asia Pacific Region (APAC) and China.
We also offer extensive expertise in the collection of clinical data for clinical evaluation for Europe (according to MedDev guidelines and (EU) 2017/45) as well as for approval in China.