We would like to inform you about the state of development of the HUM Gesellschaft für Homecare und Medizintechnik mbH regarding the upcoming new Medical Device Regulation (EU) 2017/745 - „MDR“).
The original effective date of May 2020 was postponed by one year after the approval of the European Parliament on 17 April 2020. Here you will find the corresponding notification from BVMed.
When will the MDR come into full force?
At the end of the transitional period of the currently applicable Medical Device Directive 93/42/EEC ("MDD" for short), all medical devices must comply with the MDR as of 26 May 2021 and all requirements which concern the company and the documentation for placing medical devices on the market must be implemented.
Are there any exceptions?
As with almost all regulations, there are exceptions to the MDR. Products for which we as the manufacturer can provide valid Certificates in accordance with the MDD's Annexes may continue to be manufactured and sold until these Certificates expire, without having to switch to MDR in May 2021. You can find our valid Certificates on our website www.hum-online.de in the download area under Certificates.
How will HUM position itself?
Our Annex Certificates according to Annex II and Annex V of the regulation 93/42/EWG (MDD) are valid until 26.05.2024. This means that we can continue to place our Class IIa and IIb medical devices on the market until these Certificates expire. We aim to place all Class IIa and Class IIb medical devices on the market according to MDR after the validity of the Annex Certificates has expired.
Class I medical devices must be converted to the requirements of the MDR by May 2021. Of course, we are also working on a timely convertion of the affected Class I products.
We, the HUM Gesellschaft für Homecare und Medizintechnik mbH, will continue to be available to you as a competent and reliable supplier for legally compliant medical products according to MDR even after the transition period from MDD to MDR expires in May 2021 and after the Annex Certificates expire in May 2024.
Please do not hesitate to contact us for any questions.
Your HUM team