Task completed – We are MDR compliant

In future, uniform rules will apply throughout Europe for the approval, production and distribution of medical devices, which also include rehabilitation aids. This is prescribed by the so-called Medical Device Regulation (MDR), which replaces or supplements previous national regulations. The MDR has an impact on numerous areas. These include technical documentation, clinical evaluation, the reuse of devices and the provision of data, for example for traceability or risk analysis and assessment to prove safety. In future, these requirements must be incorporated into an existing quality management system, which also requires process adjustments. We talked to Jens Fuchs (Quality Manager at Schuchmann) about the topic.

Because of the Corona crisis, the EU Commission had decided to postpone the new Medical Device Regulation (MDR) by one year to 26 May 2021. What is the MDR actually for?
The MDR provides a new legal framework for the manufacture and
distribution of medical devices at the European level. This is intended to set higher standards for quality and safety. The MDR replaces the previously applicable European legal requirements of the MDD – Medical Device Directive. While the requirements of the directive still had to be implemented in national law in the form of the Medical Devices Act (MPG), the requirements of the MDR are directly binding in all European countries. This means that the same requirements apply to all medical devices and also to the economic actors involved in Europe. Country-specific differences are thus eliminated. In addition, a central European database will be available from May 2022, in which all economic operators, manufacturers and their products must be registered and labelled accordingly before being placed on the market. In addition, all reportable incidents will be documented there.

What impact will the Medical Device Regulation have on manufacturers of medical devices?
The basics of the legal framework are not new. They are already described in the previous Medical Device Directive MDD and the Medical Devices Act MPG. The new MDR describes everything in much more detail and therefore no longer leaves so much room for interpretation. However, the MDR also describes new additional or extended requirements. For example, “identification and traceability”, “clinical evaluation”, “post-market surveillance” and it describes what happens to the product over its entire lifetime, what properties the materials used must have and so on. Especially in the design and selection of the materials used, we have been using high-quality and compatible materials for years. All the materials we use – especially those that come into contact with the user’s skin – must have proof of biocompatibility and demonstrate flame-retardant properties. Due to very long supply relationships with our important material suppliers, nothing changes for us in this respect.

What about the clinical evaluation?
Our clinical evaluations are all up to date. Our quality management system provides for an update of the clinical evaluations in the case of various events. For example, if changes are made to a product or there are new therapeutic findings. If no events occur, the clinical evaluations are checked for up-to-dateness after five years at the latest.

Often, assistive devices come into reuse – i.e. are no longer in mint condition. What does the MDR prescribe in this case?
Devices intended by the manufacturer for reuse must be reprocessed before they are changed by the user. The MDR understands “reprocessing” to mean, on the one hand, the testing and restoration of technical and functional safety. This includes maintenance and, if necessary, the repair or replacement of defective components. On the other hand, hygienic safety must also be ensured. This includes basic cleaning and disinfection of the product. It also makes sense to replace parts such as pads and covers that come into contact with the user’s skin.

Reprocessing, maintenance and disinfection costs money. For example, labour costs, for cleaning agents, spare parts, etc. Who bears the costs and who takes care of the maintenance?
As manufacturers, we are obliged to determine the scope of maintenance and the type of cleaning and disinfection for each individual product. The actual effort depends heavily on the condition and type of product intended for reuse and can vary greatly. In principle, the operator is responsible for reprocessing. The specialised trade is then commissioned with the reprocessing and settles the costs directly with the operator.

Is data also collected for this purpose?
The MDR prescribes complete traceability of medical devices. The operator determines which of his products is to be reused and must also document this. The specialised trade carries out the reprocessing and documents the scope of the necessary work and is also responsible for the further traceability of the product in reuse.

The topic of traceability. What data is available?
The new MDR-compliant type labels contain additional information such as the UDI-DI, i.e. an alphanumeric code to identify the product model, and the UDI-PI, an alphanumeric code for the production unit such as a serial number. Furthermore, the product name, size, date of manufacture and maximum load are noted. In addition, there is a marking that it is explicitly a medical device. Complete traceability is to be ensured via the data stored in the European database Eudamed (e.g. UDI). Traceability does not end with the manufacturer, but concerns all economic actors involved. Especially in the case of incidents, information on the product must be available quickly and completely to all economic actors involved.

Does MDR conformity also have to be evident in the instructions for use / CE declarations of conformity?
Yes. If all requirements for the conformity assessment procedure are met, an EU declaration of conformity can be issued for a product. The manufacturer is then entitled to affix a CE mark to his product. In our case, the declaration of conformity is part of the instructions for use, which are an important part of the product. In addition, the requirements of the MDR for the instructions for use must of course also be implemented. Before a product is delivered, the specialised trade has the task of checking the documents supplied by the manufacturer.

How does the MDR deal with additional adaptations of serial products?
Since users have a wide variety of requirements for the products, the standard configuration options are not sufficient in special cases. For these cases, the MDR provides for “customisations” of series-produced products. These special designs can be made directly by the manufacturer and labelled accordingly, or they can be made subsequently by the specialised trade. If the specialised trade makes modifications to products, it thereby also assumes the role of manufacturer of the modified product. However, the manufacturer remains responsible for the delivered product base that has not been modified.

Thank you Jens Fuchs (Quality Manager at Schuchmann) for the interview.

Terminology:

MDR:	Medical Device Regulation (EU Regulation 2017/745), enters into force on 26.5.2021, legally binding in the EU
MDD:	Medical Device Directive (Directive 93/42/EEC). Previous European regulation will be replaced by the MDR.
MPG:	Medical Devices Act will continue to exist. However, it will be supplemented by the requirements of the MDR.
EUDAMED:	European Databank on Medical Devices. The EUDAMED goes back to a decision of the EU Commission (2010/227/EU).
Basis-UDI-DI:	primary alphanumeric identifier of the product model or a product family (e.g. for smilla.)
UDI-DI:	unique alphanumeric code for the product model, access key to the product information in the Eudamed database (e.g. smilla. size 1)
UDI-PI:	unique alphanumeric code of the production unit / batch, which corresponds to the serial number for us (e.g. smilla., size 1, with selected configuration)