On 26th May 2021, the EU Medical Device Regulation (EU) 2017/745 (MDR) comes into force, thereby replacing the Medical Device Directive (MDD) 93/42/EEC. It represents a significant change regarding transparency and traceability on the Medical Device market. Let us now look at how SHIELD Scientific laboratory and cleanroom gloves are impacted by this new Regulation.
Do SHIELD Scientific laboratory latex and nitrile gloves comply with the new EU MDR?
All our laboratory latex and nitrile gloves (boxed products) are dual registered. In this respect, they are designed for both personal and patient protection. As such they are registered to respectively the EU Personal Protective Equipment Regulation (EU) 2016/425 (PPER) and the MDR. Specifically, the principle intended purpose of SHIELDskin CHEM™, SHIELDskin™ (non-sterile nitrile gloves), ecoSHIELD™, duoSHIELD™ and SMARTLine™ latex and nitrile glove brands is personal protection from chemical and biological hazards. Accordingly, they are registered as PPE Category III (Complex Design) gloves. Additionally, they comply with the new MDR and are classified as Class 1 medical devices for use as medical examination gloves.
To enable users to be better informed, SHIELD Scientific now displays specially designed pictograms identifying whether the glove is registered to the MDR or PPER or both. These pictograms are displayed on the packaging and various documentation (e.g. Product Data Sheet).
Do SHIELD Scientific sterile and non-sterile cleanroom gloves comply with the new MDR?
Our SHIELDskin XTREME™ latex and nitrile sterile and non-sterile cleanroom gloves are not registered according to the MDR. They are designed exclusively for personal, process and product protection. In common with all our gloves, SHIELDskin XTREME™ cleanroom gloves protect against a wide range of contaminants and are registered as PPE Category III (Complex Design) according to the PPER.
To the best of our knowledge, SHIELDkin XTREME™ cleanroom disposable gloves are not used for patient protection and therefore it is not necessary to register them as Class 1 medical devices according to the MDR. We may revise our position on this subject if subsequent market feedback suggests otherwise.
With regard to packaging and documentation relating to SHIELDskin XTREME™ gloves, a pictogram highlighting their registration to the PPER is featured:
Under the new MDR, what are the main responsibilities for SHIELD Scientific?
Just in the same way as the PPER represented a significant step-change to the Personal Protective Equipment Directive (PPED), the same is true with the MDR compared to the MDD. Crucially the MDR is far more wide-ranging in its scope and all economic operators in the supply chain are covered (manufacturer, authorised representative, importer and distributor). Key responsibilities for the manufacturer are to undertake registration of the device in the central European medical database EUDAMED, conduct a conformity self-assessment, implement a quality management system plus a system for risk management and draw up the necessary technical documentation. As part of this overall process, there are number of new requirements including:
According to Article 31 of MDR (EU) 2017/745, a Single Registration Number (SRN) needs to be obtained. The SRN identifies the manufacturer and as per Annex IV of the MDR needs to feature on all applicable documentations, where the MDR is referenced. With EUDAMED not operational until May 2022, the SRN is provided by the local EU competent authority. In the case of SHIELD Scientific, the SRN has been provided by CIBG Farmatec in the Netherlands (https://english.farmatec.nl/).
For your information, our SRN is NL-MF-00000169.
In an effort to enforce better traceability of Medical Devices, the EU through the MDR is implementing a Unique Device Identification (UDI) system. The latter consists of three parts:
– Basic UDI-DI,
At this stage, SHIELD Scientific has fulfilled its obligations in terms of having available a Basic UDI-DI. The latter is the main key in EUDAMED for linking devices with relevant technical documentation and you will notice that the Basic UDI-DI is already featured on relevant Declarations of Conformity (DOC). The Basic UDI-DI is generated by an approved EU body (in the case of SHIELD Scientific this is GS1: https://www.gs1.org/).
In due course, both the UDI-DI (Device identifier) and UDI-PI (Product identifier) will appear on the packaging (UDI-carrier), but it should be noted that according to Article 123(3f) of the MDR for class 1 medical devices this is not mandatory until May 2025. The UDI-DI is static and identifies the product (e.g. duoSHIELD™ ICE NITRILE™ 240), whilst the UDI-PI is dynamic in so far as it covers lot number, expiry date etc.
Declaration of Conformity extract
Under the new MDR, what are the main responsibilities for distributors?
According to Article 2 “Definitions” of the MDR, “a distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service”. In this context, distributors are responsible for checking compliance, ensuring that product is correctly stored and transported, undertaking post-market surveillance, managing complaints etc. More information on this subject can be found in Article 14 “General obligations of distributors” of the MDR.
To conclude, it is important to understand that all economic operators (manufacturers, authorized representative, importers and distributors) in the supply chain must comply with the new MDR. All have clear responsibilities. For the purposes of traceability and compliance, each economic operator must ensure that the preceding economic operator is compliant with the MDR.
Each economic operator must implement clear and effective procedures to properly substantiate conformance to the General Safety and Performance Requirements. Non-compliance could lead to the failing economic operator being subjected to legal penalties, including a ban of all products in the EU market, prosecution, fines and imprisonment.
During these pandemic times associated with glove shortages, there have been many reports of poor-quality products entering the EU. Under this new regulatory regime, importers of gloves from less well-established manufacturers (including private label products) may struggle to achieve compliance to the new MDR.
Should you have any further questions, please do not hesitate to contact us (Click HERE).