seleon newsletter march 2023

The MDR (EU) 2017/745 and its 2023 deadline amendments

As early as December 2022, a murmur went through the medtech sector. At the EPSCO meeting (“The Employment, Social Policy, Health and Consumer Affairs Council “) shortly before Christmas, EU Commissioner Stella Kyriakides announced that the MDR would be amended in 2023. Then, in January 2023, a?proposal from the Commission?appeared to stagger the deadlines and relax the market. The proposal provided for only a short transitional period, so that?the Parliament also agreed in its session in mid-February 2023.?Now only the publication in the Official Journal is necessary so that the regulation can enter into force immediately.

Link: https://www.seleon.com/en/the-mdr-eu-2017-745-and-its-2023-deadline-amendments/

Technical documentation – international concepts for demonstrating safety and performance

If a product is to be approved for sale in several markets, you should think carefully about how you want to create your technical documentation. It is probably not efficient to create a separate technical documentation (TD) for each country in which you want to sell a product. The human resources needed to maintain this amount of TDs would probably increase immeasurably. To counteract this problem, there are various organizations that have thought about format specifications in order to consolidate the requirements.

Link: https://www.seleon.com/en/technical-documentation-international-concepts-for-demonstrating-safety-and-performance/

The IVDR: One year after its entry into force

The IVDR 2017/746 regulation for in vitro diagnostic medical devices has been in force for a few years and with the start of validity on 26 May 2022, the time has now come for a first stocktaking. As a result of the changes, some in vitro diagnostic medical devices must be classified in higher levels and certified for the first time with the involvement of a Notified Body. However, since some questions remained unanswered shortly before the entry into force,?the transitional periods were adjusted to?relieve the manufacturers in this point. Now another change is about to be released: the sell-off deadlines will no longer apply.

Link: https://www.seleon.com/en/the-ivdr-one-year-after-its-entry-into-force/

23. - 25. MAI 2023, NüRNBERGMedtecLIVE with T4M

From May 23 - 25, 2023, the players in the medical technology industry will come together at MedtecLIVE with T4M in Nuremberg. For three days, everything will revolve around the value chain in the manufacture of medical technology as well as medical technology solutions and products. The seleon experts are looking forward to your visit at Hall:1 Booth:1-554! See you soon :-)

Please call or send us an email ([email protected]) for an free-entry ticket!

Link: https://www.medteclive.com/en