You are driving the MDR project at Berlinger forward strongly. What are the major challenges – especially when it comes to implementation?
As an ISO 9001 company, we were forced to start an MDR project internally, because according to MDR Article 22, a company that creates “system and procedure packages” must ensure the integrity of the components. The MDR is truly a complex riddle, and it has an immense impact on our product portfolio and internal processes and is a huge challenge for us as a small-medium-sized enterprise.
In order to comply with the MDR, we had to set up and implement several completely new processes - from R&D, through the supply chain, to production. In addition, the documentation obligation during the development and production of system and procedure packs (Sales Units) is an essential part of the MDR, which puts a strain on our internal resources.
With the support of external partners, many measures have been taken and the specific know-how has been built up internally as Berlinger will only supply our customers with products that fully comply with the regulation.
The schedule is more than tight, and each detail must be considered and takes time. For example, the new packaging design with label layout, testing with the transport simulation, and checking compliance with the sterile barrier has already taken several weeks and even months. We are doing our best to make sure we comply with the new MDR by the end of October 2021.
What changes does the new MDR bring for the European Community?
Overall, the new MDR will limit the selection of Blood collection sets for the European Community. Once our new MDR-compliant portfolio is in place, our EU customers can choose between Blood Serum, Whole Blood and Blood pass Blood Collection Sets with either the newest Butterfly Needle or the Eclipse Needle manufactured by our partner BD.
It also means that a BCO as end-user receives one unit (Sales Unit), which includes five Blood Collection Sets (referred to as Application Unit in the MDR). The Sales Unit must be sent to the user and all five Blood Collection Sets must be used by this user. The Sales Unit is validated and complies with the MDR requirements.
In addition, it is no longer possible to co-pack the blood collection sets in our BEREG-Kits due to regulatory constraints and their validation requirements. In order to reduce the assembly complexity, the customer can order the blood collection sets and BEREG-Kits separately.
In many countries, the blood collection sets fall under regulation, but the BEREG-Kits are not regulated. A combination of both products leads to regulatory questions from health authorities and in the past, these goods got stuck during custom clearance. After careful consideration, Berlinger decided to separate the two articles, especially to avoid a delay in shipping.
Where do you see the benefits for the international community?
First and foremost, the international community will benefit from state-of-the-art, high-end needles, and blood collection sets. Once the portfolio is defined, we will offer the same options to the international community as are available in the EU-BCS-Set with Blood Serum, Whole Blood and Blood pass Blood Collection Sets, which come with either the latest Butterfly Needle or the Eclipse Needle from BD. Another benefit is that the blood collection sets come in a double chamber bag and the needle is separated from the vacutainer.
In general, we are convinced that more and more countries outside the European Union will sooner or later either directly apply the MDR or bring their regulations closer to the MDR standards. It is, therefore, to be expected that the MDR will equal the Food and Drug Administration (FDA) regulations and will have the same significance to the “MedTech” industry that the FDA has for related industries and markets. This was a major driver behind our decision to also apply the MDR standards to the international community, as well as "cleaning up" our non-EU portfolio.