The European Commission´s proposed regulation amending the MDR was published on April 3, 2020 and adopted in the European Parliament on
April 7, 2020. With the decision of the European Parliament, the start of the MDR is now postponed by one year and the notified bodies designated under the previous legal framework
remain named for another year.
On April 5., 2017, the EU Parliament adopted the new Medical Devices Regulation (MDR). The scheme entered into force on May 25., 2017.
Due to lower personnel capacities and funding opportunities, small SMEs
could be particularly hit hard by the demanding new clinical requirements as well as the comprehensive documentation and reporting obligations.
Under the new rules, medtech companies will have to:
Provide substantially more clinical evidence to get products to market, or even to keep some products on the market
Conduct deep portfolio audits to determine the new rules’ impact on margins
Relabel products and make data ready to be made publicly available
We will support our clients in this transition by:
providing guidance to quality and risk related questions
supporting transition planning (MDD -> MDR)
helping with strategy planning and finance consulting
supporting due diligence activities and M&A activities
providing guidance to clinical trial planning and clinical evaluation reporting