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Team-NB legal opinion: EU MDR Article 50 breaches CFREU Article 16; disproportionate fee cuts, payment deferrals and compulsory acceptance for notified bodies; invalid if adopted

Published on: 26 May 2026

Published by LNB News
Legal News

LNB News 26/05/2026

Document Information

Issue Date: 26 May 2026

Published Date: 26 May 2026

Jurisdiction(s): European Union

Article summary

Legal expert opinion on MDR Article 50

Team-NB, the European Association of Medical Devices Notified Bodies, has released a legal expert assessment finding that the draft Article 50 in the update to Regulation (EU) 2017/745 (Medical Device Regulation, MDR) would unlawfully encroach on the freedom to conduct a business guaranteed by Article 16 of the Charter of Fundamental Rights of the European Union (CFREU). The assessment says that the contemplated measures-compulsory fee cuts, delayed payment terms and a potential duty on notified bodies to take on conformity‑assessment applications-are disproportionate and surpass what the Charter allows, even though they aim to assist small and medium‑sized enterprises, foster innovation, secure device supply and safeguard public health. It further maintains that the proposal transfers the financial load of these public‑policy aims to private notified bodies without compensation or sufficient cost protections. Accordingly, the opinion finds that Article 50 of the MDR would violate Article 16 CFREU and, if enacted as currently drafted, would be invalid and without legal effect. Source: Legal expert opinion on MDR Article 50...

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