Tuttlingen - First-hand information so that the first attempt works as well as possible: At the online symposium "MDR Audits - Best Practice & Learnings" of MedicalMountains GmbH and the business development agency of the city of Tuttlingen, notified bodies and successfully audited companies shared their findings and trends . Both sides want the process to run smoothly because the time factor continues to play a major role.
Managing director Julia Steckeler and project manager Meinrad Kempf led through the day on behalf of MedicalMountains GmbH. Representing the co-organising economic development of the city of Tuttlingen, Mayor Emil Buschle emphasized the role of medical technology "as the mainstay of the economy": "We are aware of the major challenges you and we as cities and municipalities are facing." Challenges that Tuttlingen , are the same in Baden-Württemberg and all of Germany, Julia Steckeler recalled when looking at the geographical distribution of the around 110 participants. #
Before going into the details, Dr. Bassil Akra, Managing Director of QUNIQUE GmbH, outlines the status of the MDR implementation. The intention of the 175 pages of EU-MDR was to answer questions and create harmonization. However, the now 55 guidance documents and different national laws show that people in Brussels and in the member states are very unsure how to deal with it.
The speakers were able to convey more security, at least with MDR audits. Tobias Hensler, Tuttlingen branch manager of mdc medical device certification GmbH, listed points that were often found during audits. He referred to a survey according to which more than 7,000 certificates will expire in 2024. Accordingly, the resources would have to be planned both at notified bodies and in the companies. The time factor was also highlighted by Dr. Max Singh from TÜV SÜD Product Service GmbH. "The better the technical documentation is structured, the better the notified body can make progress." Annex II of the EU-MDR can serve as a "good table of contents".
Wulf Brunow (Richard Wolf GmbH) and Karim Djamshidi (Karl Storz SE GmbH & Co. KG) showed what was remarkable in their companies before and during the MDR audit. This included, among other things, that the internal audits were examined more closely and the associated training certificates were requested. Outsourced processes also played a bigger role. A clear announcement was made on a topic that had been much discussed in the past: External documents from suppliers must be physically available in full at the audited company.
The question of further postponements - for example when the MDR came into force - was viewed critically overall. Nevertheless, MedicalMountains GmbH is staying tuned at state, federal and European level in order to push for realistic simplifications for everyone involved, emphasized Julia Steckeler. All recommendations for action would benefit both patient protection and the security of supply with high-quality European medical devices.
That outlined another output of the day: support continues at many levels. The business promoter of the city of Tuttlingen, Simon Gröger, is available to Tuttlingen companies as a personal contact for all matters relating to business development. With its support offers, MedicalMountains GmbH covers the whole of Germany and the neighboring German-speaking countries.
Findings in MDR audits; Examples mdc:
- IR products are not classified under Rule 6; Purpose and area of application must be clear.
- Coatings are not sufficiently considered in risk analysis and processing validation.
- Laboratory results and documents are not finally evaluated (summaries).
- Insufficient consideration of all phases of processing validation including aspects such as packaging and storage
- Validation results do not match the lived process
- Manufacturer obligation neglected in outsourced processes; Responsibility is transferred to suppliers.
- The state of the art is not adequately recorded.
- Standards are the old version.
- Procedure for UDI not yet specified.
- Art. 120 EU-MDR (transitional provisions): Even without an MDR certificate, the requirements for post-market surveillance, market surveillance, vigilance and the registration of economic operators apply.
Findings in MDR-Au
