At MedtecLIVE 2023 in Nuremberg, Steffen Eschinger, strategy consultant for medical technology companies, reported on which procedures have proven to be effective for the (re)certification of medical devices and which pitfalls should be avoided at all costs.
"You won't get away with it. Go back to work and come back in two years' time." No company that has prepared long and hard for an appointment with one of the so-called "notified bodies" wants to hear sentences like these. But Steffen Eschinger knows that they can happen during an MDR audit. The managing director of the consulting company of the same name has already successfully guided several medtech companies through the regulatory jungle.
It doesn't work without checklists
In his presentation "Effective supplier management in medical technology: requirements, implementation and best practices under MDR and LkSG" at the BME Purchasing Day at the last MedtecLIVE in Nuremberg, the expert gave a vivid account of problems that can arise and strategies for solving them.
As the first necessary step, Eschinger emphasised the derivation of all criteria to be observed by the company from the relevant standards and the subsequent recording of these in checklists. Eschinger also reported from his practical experience how difficult it can be to fulfil the requirements of Germany’s Supply Chain Due Diligence Act (LsKG): "Nowhere are suppliers properly prepared to be medical device suppliers." Accordingly, medtech manufacturers who are obliged to ask a supplier outside of Europe questions such as "Which auxiliary materials do you use in production?" may not receive an answer. Fortunately, there are other suppliers who are able and willing to answer these questions.
On-site inspections mandatory
Increasingly stringent requirements are also being placed on companies' risk management. According to the law, suppliers must be inspected on site to ensure that what is stated in the technical documentation is actually being practised.
In view of the major challenges, Steffen Eschinger warns against postponing the necessary and time-consuming preparatory work for (re)certification, despite an extension of the MDR deadline to 2027/2028.
