Quality Management
MED TRUST – reliable quality
Why we pay attention to quality
As health is our top priority, we pay attention to quality at every step, from the idea to the product. This means that we produce our products safely, reliably and in accordance with strict regulations. This enables us to provide our customers with the best possible medical product to help them in their everyday lives.
This means that we not only manufacture and sell products, but also take responsibility – for you. For your safety, your health and your trust.
We endeavour to make life easier for patients and partners. With innovative ideas, advice and service.
This also means that our quality does not end with the sale of the product. Our quality should remain. We therefore keep a close eye on how our medical products prove themselves in everyday use. Feedback from users, patients and professionals helps us to constantly improve our range.
Quality - signed and sealed
Compliance with the strictest legal requirements for our healthcare products and services forms the basis of our activities.
The best proof of MED TRUST’s demanding quality management system is the many years of certification in accordance with EN ISO 13485:2016 and the confirmation from the notified body that the conformity of our medical devices and in-vitro diagnostics corresponds to the current EU requirements MDD / MDR and IVDD / IVDR through the EC certificates.
The EU regulations for medical devices 2017/745 (MDR) and in-vitro diagnostics 2027/746 (IVDR) set much higher standards for the technical documentation of medical devices in many respects in order to ensure a high level of performance, safety and health protection.
Our dedicated MED TRUST Quality Management/Registration team is continuously working on updating the Technical Documentation of our Wellion products to maintain CE conformity throughout the transition phase, so that our products are available compliant on the market.
MDR and IVDR
What is changing for medical devices and in-vitro diagnostics?
The new regulations on medical devices (MDR) / in vitro diagnostic medical devices (IVDR) have been in force in the EU since 26 May 2021 and 26 May 2022. They replace the previous regulations (MDD/IVDD) and bring far-reaching changes for manufacturers, importers and distributors.
The aim is to further increase the safety and quality of medical devices to protect patients.
What is new under the MDR/IVDR?
New risk classes for products
Medical devices are categorised even more precisely according to their risk – from Class I (low risk) to Class III (high risk). In vitro diagnostic medical devices are now categorised more strictly and clearly according to their risk – from Class A (low risk) to Class D (highest risk).
The new categorisation has a direct impact on the testing procedures of the notified body and the requirements for the technical documentation of the products. The higher the class, the stricter the assessment procedures.
More responsibility for Notified Bodies
Independent testing institutions (so-called “notified bodies”) also have a greater responsibility in the evaluation and approval of medical devices.
Clear rules for all market participants
The tasks and obligations of manufacturers, authorised representatives, importers and dealers are regulated much more precisely so that responsibility remains traceable.
More control after market launch
Manufacturers must also continuously monitor their products after sale. Reports of problems and side effects are monitored and evaluated more strictly (post-market surveillance and vigilance).
Higher requirements for clinical data
More and better documented clinical evidence is needed to prove the safety and performance of medical devices, especially for high-risk products.
Introduction of unique device identification (UDI)
Every medical device, including in-vitro diagnostics, is subject to the new product identification system through the unique identification number, UDI (Unique Device Identifier), with which it can be clearly traced and identified worldwide.
More transparency thanks to EUDAMED
In the new EU database for medical devices (EUDAMED), important information on products and studies will be made public in future to ensure greater transparency and trust.
MED TRUST is already listed in EUDAMED with the following Single Registration Number (SRN):
Manufacturer: AT-MF-000000311
Importer: AT-IM-000000335
System and Procedure Pack Producer: AT-PR-000038336
MED TRUST conscientiously fulfils its duty of care under MDR/IVDR and, above all, wins satisfied customers whose trust in us continues to grow!
FAQs on the topic of MDR / IVDR at MED TRUST
What is the aim of the new EU MDR / IVDR regulations?
The background to the MDR and IVDR is the demand for greater safety of products and their follow-up after they have been placed on the market. It is intended to lead to better protection of public health and patient safety, including greater transparency and traceability.
Which MED TRUST products are affected?
All medical devices and in-vitro diagnostics.
What is the conformity assessment?
Medical devices are subject to CE labelling and must have undergone a so-called conformity assessment procedure, which must ultimately be carried out not only by the manufacturer, but also by the “so-called” Notified Body. The positive completion of such a procedure for the products is confirmed by the issue of an EC certificate by the notified body.
What is a declaration of conformity?
The declaration of conformity is a document with which a manufacturer of a product declares under its own responsibility and in a legally binding manner (manufacturer’s declaration of conformity) that its product fulfils the requirements of the relevant EU directives.
Declarations of conformity of registered products are provided by MED TRUST for authorities and current inspections, as required by the MDR and IVDR, Article 14 “Obligations of distributors”.
How can a customer (retailers, pharmacies, hospitals, partners, etc.) of MED TRUST products check the conformity of the products?
MED TRUST products are clearly labelled with the CE mark on the packaging, for EC certificates see also:
What do transition periods mean for MDR and IVDR?
If EC certificates have been issued in accordance with Directives 90/385/EEC and 93/42/EEC, these remain valid until the end of the period specified in the certificate. Provided that there are no significant changes, e.g. organisational changes, changes not related to the design and intended purpose. Parallel certifications are possible until 26 May 2020. The last MDD / IVDD certificates expire on 26 May 2024 and 26 May 2025 and the products can be sold for an additional year in each case.
What are the costs of MDR/IVDR at MED TRUST?
MED TRUST is continuously engaged in the creation of resources to ensure the timely implementation of EU regulations. Investments in the millions are increasingly being made, with the main cost drivers including the creation of higher-level technical documentation, the increased requirements for post-market surveillance, communication and testing of outsourced processes, UDI labelling and warehouse logistics.
Does MED TRUST have a quality management system that is constantly monitored?
Yes, MED TRUST is audited annually by TÜV Rheinland as a Notified Body. In addition, internal audits are carried out in accordance with EN ISO 13485, which ensures the further development of the quality management system in line with the new EU requirements.
Does MED TRUST fulfil the requirements of the MDR/IVDR?
The technical documentation for Wellion medical devices is continuously edited and updated in accordance with the latest guidelines (MDCGs) and requirements of the “state of the art” standards.
