Article about the Medical Device Directive EU 2017/745


At PakuMed medical products gmbh, intensive preparations are underway to implement the new requirements of the MDR as quickly as possible.

Here we have compiled some information on the subject of MDR for you:

In May 2017, the new European Medical Device Regulation (MDR) EU 2017/745 came into force.

The new regulation replaces the existing 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 Directive 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.

In future, around 500,000 existing medical devices in Europe will be (re)certified in accordance with new, extended rules for obtaining the “CE mark”.

However, it is estimated that only about 65% of medical devices will be certified according to the new rules. 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 inevitable.