Simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and support of the European Medicines Agency for the expert panels on medical devices and the list of Union harmonisation legislation

It affects medical-device and diagnostic-test manufacturers, especially SMEs, healthcare institutions making in-house devices, patients needing niche or innovative devices, notified bodies, and online sellers of devices.

• Removes fixed certificate expiry and replaces recertification with risk-based periodic reviews by notified bodies.
• Reduces reporting, documentation, audit, and notified-body requirements for lower-risk and established devices.
• Creates priority pathways for breakthrough and orphan devices, with expert-panel advice and rolling review.
• Expands digital procedures, Eudamed reporting, regulatory sandboxes, and EMA support for expert panels and authorities.

Transitional law

Single-use device reprocessing rules apply five years after entry into force; qualifying legacy orphan devices may remain on the market subject to conditions.

• Regulation (EU) 2017/745 (32017R0745)
  • art. 1: amends scope, SoHO references and combined MDR/IVDR product rules
  • art. 2: amends and deletes definitions; adds well-established technology, combined study and sandbox definitions
  • art. 3: replaces Article 3 on amending and implementing certain definitions
  • art. 4: replaces Article 4 on regulatory status coordination
  • art. 4a: inserts opinion and determination procedure for regulatory status
  • art. 5: amends in-house device conditions and adds delegated/implementing powers
  • art. 6: amends distance sales and diagnostic or therapeutic services requirements
  • art. 7: extends claims restrictions to devices used for services
  • art. 9: amends scope for common specifications
  • art. 10: removes certain manufacturer obligations and amends QMS, language and design/manufacturing rules
  • art. 10a: amends supply interruption reporting and adds IT tool and EMA list methodology
  • art. 11: deletes paragraphs 4 and 5 on authorised representatives
  • art. 14: amends distributor verification requirements and sampling method
  • art. 15: simplifies person responsible for regulatory compliance requirements
  • art. 16: amends repackaging and relabelling rules; deletes paragraph 4
  • art. 17: replaces Article 17 on single-use devices and reprocessing
  • art. 18: amends implant card information and exempts well-established technology implants
  • art. 19: allows electronic declarations of conformity
  • art. 22: amends system and procedure pack statement content
  • art. 27: clarifies UDI assignment obligations and delegated/implementing powers
  • art. 28: amends UDI database public access rule
  • art. 29: replaces Article 29 on device and system/procedure pack registration
  • art. 30: amends electronic system for economic operators and distributor databases
  • art. 31: amends registration of economic operators
  • art. 32: narrows and simplifies summary of safety and clinical performance requirements
  • art. 33: amends Eudamed and possible interoperable electronic systems
  • art. 34: amends functional specifications for Eudamed and related systems
  • art. 35: adds dispute mechanism involving authority responsible for notified bodies
  • art. 36: amends notified body requirements, including AI-related requirements and delegated power
  • art. 37: deletes paragraph 4
  • art. 39: replaces assessment procedure for notified body applications
  • art. 40: amends nomination of experts for joint assessment
  • art. 40a: inserts funding rules for designation and monitoring of notified bodies
  • art. 41: amends language requirements for notified body documentation
  • art. 42: amends designation and notification of notified bodies
  • art. 44: amends monitoring of notified bodies and joint assessment involvement
  • art. 45: deletes Article 45
  • art. 46: amends changes to designation and restrictions on notified bodies
  • art. 47: amends challenge procedure for notified body competence
  • art. 48: retitles and deletes paragraphs on peer review/exchange provisions
  • art. 49: replaces coordination of notified bodies provisions
  • art. 50: replaces Article 50 on access to notified bodies and fees
  • art. 51: amends classification coordination and powers
  • art. 51a: inserts classification dispute procedure between manufacturer and notified body
  • art. 51b: inserts procedure challenging classification of CE-marked devices
  • art. 52: amends conformity assessment procedures and notified body involvement
  • art. 52a: inserts conformity assessment for breakthrough and orphan devices
  • art. 52b: inserts digitalisation of technical documentation, conformity assessment and reports
  • art. 53: amends notified body conformity assessment obligations
  • art. 54: replaces clinical evaluation consultation procedure for certain high-risk devices
  • art. 55: replaces mechanism for scrutiny of conformity assessments
  • art. 56: amends certificates, validity, conditions and surveillance activities
  • art. 57: amends electronic system entries for certificates and consultation information
  • art. 59: amends derogations from conformity assessment and Commission emergency authorisation powers
  • art. 59a: inserts derogations for serious cross-border threats, disasters or crises
  • art. 59b: inserts national regulatory sandbox rules
  • art. 59c: inserts Union regulatory sandbox rules
  • art. 60: adds certificates of free sale for systems and procedure packs
  • art. 61: amends clinical evaluation, evidence and non-clinical data rules
  • art. 62: amends clinical investigation scope wording and references Articles 75 to 80 only where applicable ناهضتعديل نطاق التحقيق السريري وإحالات المواد 75-80 حيثما تنطبق فقطحسناً العربي خطأ remove. Need final valid JSON no Arabic.