pfm medical expert gmbh is an independent subsidiary of pfm medical ag and supports and advises companies in the medical technology sector on the changeover to the EU Medical Device Regulation (MDR). How successfully the knowledge and experience is being applied is currently evident at pfm medical ag, which already holds the first three MDR-certifications.
"pfm medical ag is very well on schedule, in some cases even well ahead of all deadlines," says Katja Klein, Managing Director of pfm medical expert gmbh, commenting on the current status. There are already three certifications, for Class I r, II a, and III products. "A very good result, of which we are justifiably proud," Klein is pleased to say. Various other processes continue to run in the background. The applications for two more products have already been submitted to DEKRA. Three other product files have already been brought to MDR level and will be submitted to the Notified Body in January.
"One key to success was the forward-looking preparation," reveals Horst Gebhard,Managing Director. Personnel resources were quickly increased in the company and processes were initiated so that the extensive work around the MDR conversion could be mastered. Another advantage is the extensive and well-established study situation at pfmmedical, which is crucial for the MDR process.
"These days reports on the MDR are usually in connection with criticism of the requirements or various apprehensions. The example of pfm medical ag shows what it takes for things to go smoothly," Gebhard sums up. The parent company has benefited from the know-how of pfm medical expert. The independent subsidiary also advises and supports external companies in the conversion to MDR. The comprehensive range of services extends from a complete transfer of the quality management system from MDD to MDR to small, individual solutions, such as support in the development of technical documentation in accordance with the requirements of the MDR (STED format). "We always first look at where our customers stand and then propose customised, pragmatic solutions," says Klein, outlining pfm medical expert's approach to solutions.
01 October 2021
Despite the Corona-related postponement of the MDR start date by one year by the EU Commission, many companies continue to face major challenges in implementation. Many industry experts complain that companies are not as far advanced in the MDR process as the tight schedule would actually require.
This is precisely the problem that shows in the day-to-day advice provided by the pfmmedical expert team: many companies misjudge the tight timeframes. They mistakenly believe that they still have plenty of time due to the transition periods. But the processes have to be prepared in a complex way and sometimes take up to 12 months; a time span that many companies have not planned for properly. There is a threat of massive bottlenecks in the agencies involved in the process.
The state of North Rhine-Westphalia would like to create an additional incentive for companies in the medical technology sector and is now rewarding small and medium-sized companies from North Rhine-Westphalia that seek advice and support around the MDR conversion with a grant from the North Rhine-Westphalian Ministry of Economics.
Those who use the services of pfm medical expert can also secure the funding from the state of NRW. pfm medical expert is an independent service provider specialising in consulting on regulatory requirements for medical devices in accordance with MDR as well as support in clinical project management.
"We are pleased that the state of NRW is creating further incentives to ensure that companies receive the support they need. We share the fears of many experts that products could disappear from the market due to the MDR changeover if certification does not take place in time. That would be a great disadvantage for the German market and could weaken Germany as a location for innovation in the long run," emphasises Katja Klein, Managing Director of pfm medical expert.
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