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MDR
Pajunk supports you during the entire process and
takes care of the changes of the MDR
takes care of the changes of the MDR
MDR – The New Medical Device Regulation in the EU
On May 5th, 2017, the EU issued the new Medical Device Regulation (MDR), which will be obligatory for all manufacturers of medical devices following a four-year transition period that is ending on May 26th, 2021.
With the MDR, legislators are requiring a new approval of all products in accordance with the new regulations. For specific products (the lower Class I) implementation is absolutely essential in May 2021, whereas Class II and Class III products – under certain conditions – have a transition period that extends to 2024.
The Medical Device Regulation (MDR) stipulates significantly stricter requirements on quality management systems and technical documentation, as well as on the generation of clinical data.
Additionally, the traceability of medical devices, starting with the procurement of the raw material, through the production, the distribution of the product and the use on patients, is of great importance under MDR. All of this results in considerably more effort with regards to the documentation obligations for each medical device manufacturer and the European database EUDAMED is playing a key role in this.
Challenges and changes the MDR brings
Christian Quass, Manager Regulatory Affairs at PAJUNK®, sums up the situation as follows: “The requirements of the MDR are not completely new. It is true that the requirements regarding the control over outsourced processes, sufficient clinical data and post-market surveillance have been intensified, but these are not new requirements. What’s new is that all information about the product lifecycle now has to be made accessible to the public, e.g. with the implementation of an UDI code for each product also in Europe”.
Main changes of the MDR at a glance
“The Medical Device Regulation is an instrument of state control that, on the one hand, ideally creates complete transparency, but, on the other hand, unfortunately will hinder innovation due to much stricter requirements of innovative and life-supporting medical device manufacturers. Furthermore, the new EU legal framework will not simplify the process of placing medical devices on the market, as originally promised by the commission, but will complicate this process,” says Christian Quass.
The main changes of the MDR include:
- Expansion of the product scope to include products without a medical purpose
- Implementation of the unique product number system (UDI – Unique Device Identifier): Each product gets an individual code consisting of a device identifier (name, version of the product) and a product identifier (lot number, production date, expiry date)
- Strict clinical monitoring after placing the product on the market, for example unannounced audits and sampling inspection
- Reclassification of products according to risk, duration of contact and invasiveness
- Stricter clinical evidence for medical devices in class III and implantable medical devices
- Systematic clinical evaluation of medical devices in classes IIa and IIb
- No inventory protection: All currently approved medical devices must be certified again according to the new requirements
Pajunk and the MDR
Fortunately, Pajunk was able to start in time to put intensive efforts in the entire transition process to guarantee a smooth transition from MDD to MDR.
Pajunk is in close cooperation with internal and external partners and already successfully completed the first part of the transition process which is the successful certification of the quality management system according to extended MDR requirements.
The second step, which is taking place at the moment is the re-assessment of the technical documentation for all Pajunk products. All currently approved medical devices need to be re-evaluated by experts of our notified body DEKRA.
“Even if this represents an enormous timely and technical challenge, we are confident that we can achieve all tasks just-in-time”, says Christian Quass.
“We currently don’t see any problems with keeping up the supply of the core range of Pajunk products. According to the current state of affairs, we assume that MDR recertification can be implemented for almost the entire Pajunk portfolio,” explains Klaus Holzer, General Manager of Pajunk Medical Produkte GmbH.
“But due to Pajunk’s large portfolio size and the high regulatory effort, it will be necessary for Pajunk to use the entire transition period of four years (Article 120)”.
Besides the challenges of the MDR there are also new opportunities. Together with the preparation of product data for the upcoming EUDAMED database, Pajunk is working on the implementation of the unique product number system (UDI) and the harmonization of the product information system according to international standards.
Once done, Pajunk will be able to submit product master data not just to EUDAMED but also to use a network-based communication system for the provision of product master data through the Global Data Synchronisation Network (GDSN).
All that happens, while Pajunk keeps the clearly defined regulatory framework in mind. Overall, it is important to question processes as well as to participate in the requirements of the 21st century and to adapt to the present time.
Pajunk supports you during the entire process and takes care of the changes of the MDR, so you can focus on your patients.
"PAJUNK & MDR
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