"The sector sometimes does not react promptly enough to the new requirements"

12.09.2018 - 13:10

Many companies in the medical technology sector and exhibitors at T4M are affected by the new medical product regulations. We spoke with Christian Söhner, Global Vertical Manager Medical at FOBA Laser Marking + Engraving, about the challenges involved and his expectations of T4M.

FOBA Laser Marking + Engraving is a member of the trade fair advisory board of T4M and performs important tasks as an advisor and co-organiser of the new trade fair for medical technology in Stuttgart.

Mr Söhner, laser labelling systems make possible the traceability of materials and components throughout the entire product lifecycle. In which areas of medical technology are your products used?
Laser markings are used to label medical products in all risk categories with UDI and other codes. This includes, for example, knee or hip endoprostheses (risk category III), endoscopes (category II) and also retractors (category I).

What special requirements do customers, in particular customers from the medical technology sector, have of your precision systems?
FOBA's laser marking systems must meet the high marking requirements of the sector. Firstly, they must create high-contrast and very legible letters. Secondly, the UDI codes must be highly consistent, also across innumerable reconditioning processes, in order to comply with the FDA and MDR regulations on traceability. This also applies for revisions, which affect approximately eleven per cent of implants, as well as used instruments, which must be relabelled on account of new marking specifications or in the course of repairs. In addition, our customers demand a very efficient camera system and a stable marking process without rejects or mismarkings.

Which regulatory requirements concern you most, and why?
The soon-to-be-introduced regulations of the European MDR, here in particular with regard to the new sub-group of risk category I, the category Ir for reusable surgical instruments intended for reconditioning. For manufacturers of such products, new certification is to be introduced, which must be available by the end of the transition period on 26 May 2020.

To what extent will the expenses change in the areas of risk assessment, validation, product documentation and product support?
The sector sometimes does not react promptly enough to the new requirements. There are too few designated contact partners and the certification process has not yet been introduced in many companies.

The medical technology industry is currently facing many challenges in view of the new Medical Devices Ordinance. How do you feel about it? After all, you too have to put the labelling process on a "footing" that conforms to the rules.
We offer the necessary technology, but are also required to offer interface solutions for implementation in the companies of our customers. To this end, we work closely with our customers.

You are an exhibitor at T4M, the new trade fair for medical technology in Stuttgart. What expectations do you have of the event?
First of all, we expect good visibility in the external presentation in the run-up to the fair and good organisation in the trade fair preparation. We would like to see a clearly structured trade fair that offers exhibitors optimum presentation opportunities and good networking opportunities. I would mention the medical technology trade fair in Lucerne as a benchmark, because it shows a clear structure in its set-up. There, you have a kind of "market place" with stands at the edge and a speaker platform in the middle. So-called Apéros present a central networking offer. In the T4M advisory board, we gladly take such inspirations on board and use them to create our own attractive offers for Stuttgart.

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