Tuttlingen – The European Medicines Agency (EMA) is gaining more powers for medical devices, the Health Technology Assessment (HTA) is taking shape: At the most recent MedTalk by MedicalMountains GmbH, the developments were outlined - and in the same breath question marks were added, as in both cases the practical implementation should take place.
Until the Covid-19 pandemic, the European Medicines Agency (EMA), founded in 1995, led a rather shadowy existence in the medical device sector. Now their role in crisis prevention and management is to be further strengthened, as the title of Regulation (EU) 2022/123, which has been in force since March 1, 2022, makes clear. dr Meike Kapp-Schwoerer and Dr. Jan Henning Martens from the law firm Friedrich Graf von Westphalen & Partner (Freiburg) presented the set of rules at the MedTalk. The “Steering Group” will play a central role in this. It is intended to create a list of critical products for "public health emergencies" - such as ventilators - identify actual or potential shortages and make recommendations for action. The question arose: What should the reporting system look like, especially since EUDAMED is not yet fully operational? Will companies be required to report inventory or market share? Since dealers and their information also come into play, the lawyers thought it conceivable that dealers would in future be required to provide information in distribution contracts, for example to query customers' stock levels.
Almost in a subordinate clause of the regulation, in Article 30, the role of the EMA in the expert committees to be appointed according to EU-MDR is mentioned. Essentially, it is administrative and technical support; however, the agency is to report annually to the European Commission and the Medical Devices Coordination Group on the work of the expert panels. During the discussion, it was noted that the EMA had hardly had any contact with medical devices to date. Duplicate structures would have to be avoided, and the industry would not have to be burdened with even more regulatory work. Overall, so the impression is that the regulation was “knitted with a hot needle” under the impression of the past two pandemic years.
The next steps in the Health Technology Assessment are somewhat more tangible, although not concrete down to the last detail. The basis is Regulation (EU) 2021/2282. Put simply, the HTA is intended to serve as a decision-making aid as to which procedures should be included in public health care. dr Meike Kapp-Schwoerer and Dr. Jan Henning Martens made it clear that this is not a regulatory test or an intervention in the conformity assessment. Rather, it should be decided what added value one health technology has over the other. The stated goal is to give patients in the EU uniform access to innovative procedures - the reimbursement system, on the other hand, remains a national matter. The HTA considers Class IIb active devices and Class III implantable devices. This is the case at least for the time being, because other products may be added. However, the criteria for this are just as unspecific as the specifications for the clinical evaluation report, the two speakers pointed out. Nevertheless, they advised adapting the manufacturer's internal documentation to the content framework of the HTA, since developers of health technologies would have to submit a clearly structured dossier. At least there is still some room for improvement: the start of application is January 12, 2025, followed by a gradual expansion until 2028.
additional Information
The ordinances mentioned in the text can be accessed at the following addresses:
Regulation (EU) 2022/123 of the European Parliament and of the Council of January 25, 2022 on an enhanced role for the European Medicines Agency in crisis preparedness and management with regard to medicinal products and medical devices
https://eur-lex.europa.eu/legal-content/DE/ALL/?uri=CELEX:32022R0123
Regulation (EU) 2021/2282 of the European Parliament and of the Council of December 15, 2021 on the assessment of health technologies and amending Directive 2011/24/EU
https://eur-lex.europa.eu/legal-content/DE/ALL/?uri=CELEX%3A32021R2282
