Important role in the distribution of medical products within MDR underestimated

QA/RA and MDR compliant

The legislation surrounding the Medical Device Regulations (2017/745 EU, hereinafter referred to as MDR) places high demands on the developers and manufacturers of medical products. What the market underestimates is that these products are often distributed worldwide and buyers sometimes only receive a product months after the order. How do they know if the product still complies with the MDR and what happened to it along the way? Medical (sterile) consumer items, for example, must be transported carefully, for which the experience of the transporter is very important. In that case, a CE certificate is not sufficient. It is the importer and distributor  who oversee the entire chain and who can ensure supervision and compliance with the MDR. Robin Bijdevier, Managing Director at Vision MC, believes that their role in this is so important that they invest in it purposefully.

But a QMS (Quality Management System) can be used by anyone and is not industry-specific. We were specifically looking for a connection with healthcare and therefore started writing procedures ourselves, for example for the shelf life of sterile products. The change in the law for medical devices was the reason for us to arrange our affairs properly formally. Think of product labels with specific requirements  for storage in our warehouse. As a distributor/importer, we have to maintain these conditions. In addition, we have  been given a more extensive obligation to report customer complaints to producers , authorized representatives and authorities. So we also have to monitor the traceability of the entire chain."

Quality is paramount

"That's why we called in Gerrit Lindenschot from ICT Group. Gerrit is a true senior QA/RA consultant. Precisely because we have been working on quality assurance for so long, a kind of business blindness can easily arise. Gerrit's strength is that, as a relative outsider with a lot of experience in this field, he takes us along and shows us in great detail how we really stand and what steps are necessary. We need his knowledge of the MDR to integrate MDR into our processes. In addition, Gerrit is very committed, easy to get along with and extremely knowledgeable. We can always count on him and trust him in our pursuit of the highest quality and to at least meet the requirements of the MDR."

Sparring partner

"Gerrit first carried out an audit, a gap analysis, of our current QMS and determined which actions we can take to fulfil our role as distributor and importer within the MDR as well as possible.  Based on the results, we set up a project that we are now rolling out step by step. Gerrit acts as a sparring partner and plays a leading role in drawing up the procedures. He thinks along with us, asks the right questions, presents cases and helps to unravel the case. We have a kind of continuous evaluation moment with each other. What I am very happy about: he prevents us from making it more difficult than it is, not thinking too black and white between theory and practice. Gerrit keeps it understandable for everyone. He also regularly visits hospitals and sees how things are going. That knowledge and his honesty are very welcome to us."

Continuous optimization

"In just under 2 years, we have already come a long way and are now completing the final procedures. Qualitatively, we have really made progression. In the future, we want to comply with ISO 13485, so that we are also compliant with ISO 13485 and MDR as an importer and distributor. We continue to optimize. Gerrit's critical eye and his pragmatic way of working help us with this. He is transparent, open and cheerful, so that we are in the right flow together. As an importer/distributor, we want to  oversee the entire chain and know and control the processes and their effects on products. We are taking the lead in this so that we can demonstrate to customers that we understand their needs and that the impact of MDR is in safe hands with us. Gerrit and ICT Group are an indispensable support for us in this."