MDD / MDR

Important innovations are imminent in European medical device law. The changeover from Medical Device Directive (MDD) to Medical Device Regulation (MDR) brings with it a major work package for Ralf Thomsen's "Medical Device International (MD International)" department. Beyond that, there are also many changes in his business environment.

The new MDR Regulation will completely replace the previous MDD Directive from May 2020. TÜV NORD CERT was successfully assessed in September as part of a "Joint Assessment", thus ensuring that we remain competitive in the field of medical products and are able to certify according to MDR. In the course of the assessment, particular emphasis was placed on the high degree of competence of our auditors and technical experts. The Medical Device Team is now continuing to press ahead with our expected MDR naming in 2020.

Ralf Thomsen's team is being supported by the Competence Development Service (CDS) in their preparations for the changeover to MDR and in the appointment and qualification of new auditors and technical experts. Izabela Hrkac's team consists of twelve employees, all of whom, with the exception of one employee in Essen, are based at the TÜV NORD CERT office in Croatia. The CDS team, headed by the certification body of TÜV NORD CERT, is responsible for appointments, and maintenance and further development of qualifications under the accreditation of TÜV NORD CERT. They look after more than 7,000 qualifications worldwide and support the TÜV NORD CERT national companies as well as the technical management in all matters relevant to the profession. "In the past, we held joint training events and meetings with the CDS and the specialist department. Both parties were successfully trained in the requirements and processes. On both sides we were able to visibly increase competence and, above all, visibly improve cooperation," explains Thomsen. "A part of the CDS team was also involved in the assessment by the EU and the Central Authority of the Countries for Health Protection with regard to Medicinal Products and Medical Devices (ZLG) and was a very great support for us. Thanks to Mrs. Hrkac's team, we feel much better positioned in this area – many thanks to Croatia at this point!

In addition to the changeover to the new standard, the focus in the area of medical products is also on expanding the team. "This year alone, we have recruited eight new employees and have thus grown from 16 to 24," reports Ralf Thomsen. "By the end of 2020, we plan to have up to 50 employees in total. This also places very high demands on the existing team in terms of training and integrating the new colleagues. Integration and team building play a central role in this.

It is not only in Germany, but also internationally, that MDR is a becoming more and more important topic. In April 2019, we founded the "Project Management Circle" to improve our ability to deliver worldwide and to build up international expertise. It currently consists of eight project managers: four in Germany, three in the USA and one in Jakarta. They meet virtually every 14 days to discuss current challenges and receive further training. This is to ensure that we work with uniform processes worldwide. The training concluded with a one-week course in Essen in August. The team is constantly evolving and the Circle is already involved in certification processes and conformity assessment procedures. Thus, further companies and countries shall have access to these services.

Employees from other countries are also welcome to participate in the Project Management Circle. For this purpose, either a project manager must be appointed who is trained by TÜV NORD CERT to VETO 1, or they must be attached to another country, which already has a project manager. With a project manager of their own, foreign companies can significantly improve both speed and communication and at the same time become much more secure in their processes, and their operation in the medical sector. If you are interested, please contact Ralf Thomsen at rthomsen@tuev-nord.de or +49 40 8557 1585.

"In order to cover as many countries as possible worldwide, we are constantly looking for cooperation partners," explains Ralf Thomsen. "Recently, for example, we signed a contract with a company in Israel. This company will now begin to qualify auditors so that in the future we will have the capacity to serve medical device manufacturers in Israel locally. Our goal is to be well positioned worldwide with all these measures in the future.