For many companies, the changeover from the old Medical Device Directive (MDD 93/42 / EEC) to the new Medical Device Regulation (MDR 2017/745) went almost unnoticed.
Although this is all too understandable in the context of the turmoil surrounding Corona, it is highly important.
The MDR came into force in 2017 and has far-reaching consequences for all economic players, which means a complete upheaval in some areas.
Of course, there have been various transitional regulations and exceptions since 2017, whereby the definitive entry into force without replacement should have taken place in May 2020, but was postponed to May 26, 2021 due to Corona.
Since the MDR contains a real “monster” of regulations, we only want to limit ourselves in this whitepaper to the consequences with regard to examination gloves and disposable gloves.
The MDR will finally come into force for class 1 medical devices on May 26th, 2021. From this date onwards, only the sale of products according to MDR or the provision (sale) of goods already stored in the EU according to MDD is permitted. An import of products according to MDD (93/42 / EEC) is no longer allowed! There are still transitional regulations for products in other classes and for those where the class classification changes due to the MDR.
- All economic actors (manufacturers, EU representatives, importers) must register in EUDAMED. Every distributor (who imports the products and places them on the Community market for the first time) is considered an importer. The requirements and regulations for importers are much more extensive than under MDD.
- All declarations of conformity may only be issued in accordance with MDR 2017/745.
- Due to the required post market surveillance and vigilance, manufacturers and importers are particularly challenged. Due to the required quality management, manufacturers have an increased documentation requirement.
But this can also apply to dealers or importers if the product does not exactly comply with the MDR. In this case, the first distributor (importer) can bear the responsibilities and liabilities as the manufacturer!
A central feature of the MDR is the assignment of UDI (Unique Device Identifier), which means that products can be tracked seamlessly. Unfortunately for many, the definition of the UDI is quite complex and confusing.
First of all, every product requires a basic UDI, which can only be assigned by a very small number of notified bodies. This basic UDI applies to all sub-variations that share similar properties. For example, all size S, M, L, and XL gloves would share the same base UDI.
The allocation of the basic UDI is already mandatory when the MDR comes into force on May 26th, 2021 and must be stated in the declaration of conformity. However, this basic UDI does not have to appear on the product or packaging.
Furthermore, each variant requires a UDI-DI (Device Identifier), which must be unique and clearly assignable to the manufacturer. The manufacturer is also obliged to register this UDI-DI in EUDAMED as soon as the functionalities are activated.
Last but not least, each variant requires a UDI-PI (Production Identifier), which contains information on production such as LOT number, expiry date, production date, serial number.
These UDI-DI and UDI-PI must be applied to the product in both machine-readable and human-readable form. 1D and 2D barcodes are suitable for this.
However, there is a transition period for class 1 products until May 26, 2024 for the UDI to be attached to the product. However, it is advisable to attach the UDI at an early stage, as the conversion of the higher-classified products will mean that warehousing will be automated and, in particular, the tracking of batches and use-by dates using barcodes will be introduced.
Sooner or later, most market participants will insist on products with UDI.
References:
Original MDR text: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32017R0745
The MDR brings improved security and traceability for all market participants - both customers and sales partners - especially in the context of product safety and market surveillance.
However, especially during the changeover, there is a massive effort for all market participants. Due to the limited number of notified bodies and limited availability of EUDAMED, a rapid changeover from MDD to MDR is a highly complex, time-consuming and expensive process.
From our point of view, this harbors a great risk for availability, since most Asian manufacturers in particular have not yet made the switch to MDR - and probably will not be able to do so due to the complexity. In the short and medium term, this can lead to a market adjustment but also to delivery bottlenecks.
We are pleased that our nitrile examination gloves are fully CE-compliant according to the new MDR and are also available in large quantities.
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