The new Medical Device Regulation (MDR) and the first In Vitro Diagnostic Devices Regulation (IVDR) are likely to become European law in the second half of 2017, with transitional periods of three and five years, respectively.
Update: 5 April 2017 – The European Commission welcomes the adoption of its proposal for the new Regulations on medical and in-vitro diagnostic medical devices.
Medical device and diagnostics manufacturers are therefore likely to face huge challenges. This does not refer to global players (or multinational corporations) and/or those with more than 250 employees. These companies will not be impacted as they have the financial and human resources to cope with the upcoming changes in the certification process. Small and medium-sized companies, many of which are located in Baden-Württemberg and are highly characteristic of this region in southern Germany, will, however, not find it so easy to implement the new requirements.
Although the PIP scandal related to defective breast implants filled with industrial silicone did not trigger the process of harmonising medical device legislation, it definitely had a huge impact on the debate concerning the safety of medical products and related legislative procedures.
In 2008, the European Commission initiated a recast, i.e. a public hearing on the revision of the legal framework for medical devices. In mid-2012, the Commission adopted two regulation proposals to revise existing legislation on general medical devices (MDR) and in vitro diagnostic medical devices (IVDR). Ever since, there has been a long-running debate on the content of the two proposals. More than 600 amendments (342 relating to the MDR and 260 relating to the IVDR) have been proposed. This is a debate that is unlikely to end when the new regulations are published in the Official Journal of the EU in the second half of 2017, as the stress test of the new regulations is yet to come.
The objectives of the new regulations are convincing. They were proposed to
Can these objectives be achieved by implementing the new regulations? The industry largely doubts it. In addition, due to the costs, time and personnel increases associated with the medical device certification process, the new regulations may put micro and small companies under threat, and result in market consolidation. Micro and small companies often have neither the time nor the human resources to deal with the new regulations, each more than 300 pages long, and implement the specifications into their business processes.
The Baden-Württemberg government is gearing up for the potential effects of the new regulations on the state’s SMEs. The annual industry figures collected by BIOPRO Baden-Württemberg show unequivocally that the region is home to an extraordinarily large number of small and micro companies. For this reason, the Ministry of Economic Affairs, Labour and Housing commissioned BIOPRO Baden-Württemberg GmbH - the state’s innovation agency with a special focus on the healthcare industry - to organise an initial meeting on the new regulations and their potential impact.
In late January 2017, more than 100 people gathered to listen to information about the new MDR and IVDR. The speeches given by Nadine Benad (Head of Regulatory Affairs, SPECTARIS - German Hightech Industry Association) and Michael Kahnert (legal adviser, BIO Deutschland) provided comprehensive insights into the new regulations. The programme was rounded off with talks by experts from two Notified Bodies (mdc medical device certification GmbH and BSI Group Deutschland GmbH), Michael Schrack of Schrack & Partner and the medical device industry representatives Dr. Martin Leonhard (Executive Director Technology Management, KARL STORZ GmbH and Co. KG), David Hain from Hain Lifescience GmbH and Dr. Bernhard Gerstenecker (Senior Scientist Quality Manager, QIAGEN Lake Constance GmbH). The information provided was well received. The very positive feedback from participants showed that they felt they had been given comprehensive information about the regulations, were able to bring in discussion topics of interest and use the lunch break for in-depth exchanges. Representatives from regional administrative authorities responsible for monitoring the safety, suitability and performance of medical devices also attended the event.
What does the medical device industry see as the biggest challenges in implementing the new regulations? Participants intensively discussed the reclassification of IVDs, the disclosure of technical documentation in the OEM-PLM or supplier relation, clinical trials and the Unique Device Identification (UDI) system. It is also becoming increasingly apparent that companies with IVDs that fall into three (B-D) of the four new risk classes will in future require an assessment of their technical documentation by a third party called Notified Body, and are therefore advised to get into contact with one as quickly as possible.
The number of Notified Bodies in Europe fell from 80 to 60 between 2013 and 2016. It is expected that there will only be 40 Notified Bodies in Europe in 2018. Ten of these will be in Germany. Moreover, there is a shortage of people with the necessary qualifications. Quality management and clinical trials specialists are urgently needed.
The medical device industry, and especially small and medium-sized enterprises, will have to hire additional staff for dealing with regulatory affairs issues. The companies also expect huge additional costs for certification, and reductions in the R&D area. Negative effects are also expected in terms of the number of products launched, i.e. fewer products will be placed on the market. The industry also expects delays in the certification of new products. This information was collected from a small, non-representative survey among the medical device companies that participated in the event.