governing medical devices

▪ Medical technology has a special claim to cybersecurity measures.

This should be taken into account within the framework of the “EU

Cybersecurity Acts” in the implementation of the EU medical devices regulation and with the active participation of industry.

3. Smooth implementation of the EU regulations MDR and

IVDR for medical devices

The health industry welcomes the goals of the new EU regulations for medical devices (MDR) and in vitro diagnostics (IVDR) directed at achieving greater patient safety and assured-quality access to innovations in medical technology. In order for industry, particularly SMEs, to be able to make comprehensive preparations for the new regulations, there is a need for open and transparent communication for implementing the regulations.

As a result of MDR and IVDR, there are major changes to the demands placed on market access to medical devices. The intention is for patients to benefit from innovative, high-quality products. For this to be guaranteed, there must be an end to the current legal uncertainty resulting from a lack of implementation instruments as well as a deficiency in the number of competent certification institutions (socalled notified bodies).

The hesitant implementation of the MDR by the EU Commission and member states, in particular the continuing inadequate notification of the notified bodies (so far only 5 out of 58 bodies have been notified, as of October 2019), is impeding preparations for the new requirements to be taken by the manufacturers of medical devices. Policy-makers are urgently requested to take the corresponding necessary measures to make it possible for enterprises to carry out timely implementation. On no account must neither patients nor manufacturers be the ones to suffer from planning errors by the authorities.

With the application of the MDR from May 2020 and the IVDR from 2022 small and medium-sized enterprises are threatened with stranding on excessive bureaucracy. The additional efforts for documentation and the increased demands require a substantial amount of additional personnel and thus cause higher costs. In order to secure their livelihoods, SMEs will have to withdraw from the market products with low turnover, especially niche and specialized products. In future, users (hospitals, doctors, dentists, laboratories) will have to go without this much appreciated product variety. In some cases there will be a lack of suitable products for special indications. Opportunities should be created for these products to continue to hold their place in the market.

The regulatory requirements are very complex. The health industry criticizes the speed in applying the “Implementing & Delegated Acts” , which results in the necessary guidance documents being missing. Unclear procedure processes mean major legal uncertainty for industry. That is why a speedier implementation of the most important elements is necessary.