logo 18 • CAMLOG Partner Magazine • July 2018 NEWS 30 THE NEW MEDICAL DEVICE DIRECTIVE 2017/745 EEC Now it is here, the new European directive for medical devices (MDD). But so far only a few companies know what efforts they have to make to implement the requirements of the new regulation and to be able to carry out CE labeling according to the new MDD. It has been official since 25 May 2017: the new European Medical Devices Directive (MDD) has been published in the Official Journal of the EU. The Directive officially entered into force on 25 May 2017. After a transition period of three years, the Medical Device Directive is binding for all companies. In concrete terms, this means that from 26 May 2020, medical devices must comply with the requirements of the new MDD. Small and medium-sized companies in particular will find it difficult to meet the significantly higher requirements for quality and risk management, technical documentation and the compilation of clinical data or clinical evaluation, while at the same time meeting the requirements for UDI labelling and increased reporting obligations. For example, the MDD requires periodical updates on PostMarket-Surveillance-Plans/Reports, PostMarket Clinical, Periodic-Safety-UpdateReport, Summary of Safety and Clinical Performance. The MDD requires the quality management system of the manufacturers to include comprehensive resource management, which must include the selection and control of suppliers and even their subcontractors. At the same time, authorities such as Notified Bodies (Notified Bodies are state-authorized bodies which – depending on the risk class of the medical devices – carry out tests and assessments as part of the conformity assessment to be carried out by the manufacturer and certify their correctness according to uniform assessment standards) are required to deal with suppliers to medical device manufacturers much more critically than has been customary up to now. As a result, manufacturers will have to impose stricter standards on their own suppliers and newly regulate contractual cooperation with suppliers comprehensively. The time required to achieve CE labeling for new products will also increase from 1.5 to 3 years today to 6 to 8 years. This delay will also be reflected in the availability of innovations for patients. The costs for administration up to CE marking will increase accordingly. Presently one calculates € 0.5 to 1.0 millions for a high risk product, in the future we are looking at up to € 3 millions. Small and mediumsized enterprises will hardly be able to cope with more than one innovation per year in this sector. In particular, the increased requirements placed on the authors and investigators of technical and clinical documents are likely to represent an enormous hurdle for many companies. Conclusion: those who do not start implementing the requirements of the new MDD today, will ultimately find things difficult in the end. Many companies are already overtaxed. There is also a bottleneck with regard to the Notified Bodies, so that even companies that could afford this in terms of personnel and finances may encounter difficulties in implementation. The new MDD represents one of the biggest challenges of the past 20 years for manufacturers of medical devices. CAMLOG has dealt with this topic at an early stage and initiated appropriate measures. At the sites in Wimsheim and Basle, a GAP audit by the TÜV Süd has already been conducted in order to identify weak points and new requirements and to be able to take the appropriate measures. CAMLOG/ ALTATEC will be certified according to the new MDD in summer 2019.
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