AI Omnibus: Digital Poland Association welcomes simplification for industry but warns medtech sector is being left behind
The Digital Poland Association positively assesses the trilogue agreement reached on the AI Omnibus package, which limits some of the overlapping regulatory obligations imposed on European industry. At the same time, the organisation stresses that the adopted solutions do not cover the medical technology sector, which will still face overlapping requirements stemming from both the AI Act and medical devices legislation.
The preliminary agreement reached by the Council Presidency and European Parliament negotiators concerned proposals to simplify selected AI-related provisions included in the regulatory package known as the AI Omnibus, aimed at harmonising and simplifying AI rules across Europe.
Under the compromise reached in Brussels, machinery manufacturers will no longer be subject to double conformity assessments under both the AI Act and existing sector-specific safety regulations. This represents a real reduction of administrative and regulatory costs for European companies, particularly SMEs. The preliminary agreement also introduces, among others, a concrete timeline for the implementation of rules concerning high-risk AI systems.
– The agreement shows that European institutions are beginning to recognise the problem of excessive and overlapping regulation in the field of new technologies. This is a step in the right direction, as Europe today needs simplification, predictability and conditions that support investment and innovation deployment – said Michał Kanownik, President of the Digital Poland Association.
At the same time, the Digital Poland Association points out that the compromise failed to include the medical sector, despite earlier proposals from the European Commission aimed at reducing overlapping obligations for manufacturers of AI-powered medical devices.
– Leaving the medtech sector outside the scope of simplification is a serious mistake. European medical technology companies are already increasingly losing global competitiveness in terms of the pace of innovation deployment. Additional overlapping regulatory obligations will only deepen this problem and weaken Europe’s attractiveness as a place for developing modern technologies – Michał Kanownik stressed.
The Digital Poland Association also notes that Europe currently accounts for less than 10% of global AI investments, while excessive regulatory complexity may further limit the development of the AI market and technology investments across the EU.
The organisation also positively assesses the announcement of further actions aimed at reducing duplicative regulatory requirements through delegated acts, as well as clarifications regarding connected devices and the Radio Equipment Directive (RED).
– What Europe needs today is not additional layers of regulation, but smart and proportionate rules that support European competitiveness, AI development and the digital transformation of the economy. The AI Omnibus should become the starting point for a broader process of genuinely simplifying digital legislation in Europe – added the President of the Digital Poland Association.