Article on the Medical Devices Regulation EU 2017/745
PakuMed medical products gmbh is working intensively in quality management to complete the certification according to the Medical Device Regulation (MDR) as soon as possible.
Here we have compiled some information on the subject of MDR for you:
In May 2017, the new European MDR EU 2017/745 came into force.
The new regulation replaces the former medical device directives MDD (Medical Device Directive).
Until the end of the transition period in May 2021, medical devices could continue to be certified according to the previous directive. Since the effective date, only the provisions of the new Medical Device Regulation apply.
During the transfer phase from MDD to MDR, PakuMed medical products gmbh is monitored and audited by TÜV NORD CERT. The implementation of the MDR on existing products, especially class IIb and III, is a complex administrative process – this will also continue to be carried out with TÜV NORD CERT.
PakuMed medical products gmbh may continue to place its goods on the market during this period after application of Art. 97/94 (acc. to MDCG 2022-18).
Around 500,000 existing medical devices in Europe will be (re)certified according to new, extended rules for obtaining the “CE mark”.
However, it is estimated that only about 65% of medical devices are certified according to the new regulations. Most Notified Bodies are currently in the accreditation phase. Due to the increasing requirements for Notified Bodies and manufacturers, adjustments in the product portfolios are to be expected and unavoidable.