Compliance deadlines for regulated hardware.
The regulatory deadlines bearing down on Medtech, consumer electronics, and connected-device teams — dated, sourced, and kept current. One page per regime.
-
EU Cyber Resilience Act
Next: 11 Dec 2026
The EU Cyber Resilience Act (Regulation (EU) 2024/2847) entered into force in December 2024. Its reporting obligations have applied since 11 September 2026, when ENISA's Single Reporting Platform went live; its main obligations apply from 11 December 2027. It covers nearly every product with digital elements sold into the EU.
-
EU Battery Regulation
Next: 18 Feb 2027
The EU Battery Regulation (Regulation (EU) 2023/1542) has applied since 18 February 2024. Its carbon-footprint and supply-chain due-diligence obligations phase in via delegated acts — several of which have been delayed — and the digital battery passport becomes mandatory on 18 February 2027 for EV, industrial (>2 kWh) and light-means-of-transport batteries.
-
EU Digital Product Passport (ESPR)
Next: 18 Feb 2027
The EU Digital Product Passport registry became operational on 19 July 2026 under the Ecodesign for Sustainable Products Regulation (Regulation (EU) 2024/1781). Registry launch was the infrastructure milestone; product DPP obligations attach family by family via delegated acts, starting with the battery passport on 18 February 2027.
-
EU Right to Repair Directive
Next: 31 Jul 2027
The EU Right to Repair Directive (Directive (EU) 2024/1799) has applied since 31 July 2026, the national transposition deadline. Manufacturers of Annex II products must repair on request beyond the guarantee period, supply spare parts and repair information, and accept a 12-month guarantee extension when repair is chosen over replacement. Transposition across Member States is uneven, so the operative text is national law.
-
EU MDR Transition
Next: 31 Dec 2027
Under Regulation (EU) 2023/607, the EU Medical Device Regulation transition runs to 31 December 2027 for Class III and Class IIb implantable devices and 31 December 2028 for other Class IIb, Class IIa and Class I devices — provided manufacturers met the 2024 notified-body application milestones.
-
FDA Section 524B
In force
FDA Section 524B has required cybersecurity documentation for cyber devices since 29 March 2023, with Refuse to Accept enforced from 1 October 2023. The operative guidance is now the February 2026 revision, which supersedes the June 2025 version and aligns it to the QMSR. An incomplete package can have a submission refused before review.