MedTech EU Regulatory Updates

Stay Informed with the Latest MedTech Regulatory Updates

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Regulatory Insights for the MedTech Industry

In the fast-evolving Medical Device and MedTech sector, staying ahead of regulatory changes is crucial. Our dedicated page offers a comprehensive overview of the latest guidance, regulations, and updates to help your business stay compliant and informed. From the most recent MDCG guidance to amendments in EU regulations, we ensure you’re equipped with the knowledge needed to navigate the complex regulatory landscape.

Explore the latest updates, including revisions in IVDR and MDR, Q&A releases, and critical changes in clinical evaluations and conformity assessments, all designed to support your regulatory journey.

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Regulatory Updates

November 2024:

  • New MDCG Guidance: MDCG 2023-3 Rev. 1 Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 and Regulation (EU) 2017/746

October 2024:

  • New MDCG guidance: MDCG 2024-11 – Guidance on qualification of in vitro diagnostic medical devices.
  • New MDCG guidance: MDCG 2024-12 – Guidance and templates for conformity assessment bodies, notified bodies, designating authorities, and joint assessment teams.
  • Updated MDCG guidance: MDCG 2021-25 rev.1 – Application of MDR requirements to “legacy devices” and to devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC.
  • 2024/2849(RSP): European Parliament’s resolution on the urgent need to revise the Medical Devices Regulation.
  • New MDCG guidance: MDCG 2024-13 – Regulatory status of ethylene oxide (EtO) intended for the sterilisation of medical devices.
  • Updated MDCG guidance: MDCG 2022-5 rev.1 – Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.
  • Commission Implementing Decision (EU) 2024/2631 of 8 October 2024 amending Implementing Decision (EU) 2021/1182 as regards the harmonised standard for aseptic processing of health care products (C/2024/6872);
  • Commission Implementing Decision (EU) 2024/2625 of 8 October 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for aseptic processing of health care products and clinical performance studies using specimens from human subjects (C/2024/6874);
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September 2024:

  • Updated MDCG guidance: MDCG 2021-4 Rev.1 – Guidance on Application of transitional provisions for certification of class D in vitro diagnostic medical devices according to Regulation (EU) 2017/746 (Update of previous guidance).

 

July 2024:

  • Updated MDCG guidance: MDCG 2020-16 Rev.3– Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746.
  • Updated MDCG guidance: MDCG 2021-5 Rev. 1– Guidance on standardisation for medical devices.
  • New Q&A: Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860.
  • Updated Q&A: Q&A Rev. 2 on practical aspects related to the implementation of Regulation (EU) 2023/607 – Extension of the MDR transitional period and removal of the “sell off” periods.

June 2024:

  • Publication in the Official Journal of the European Comission of Regulation (EU) 2024/1860 of the European Parliament and of the Council of 13 June 2024 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices.
  • New MDCG guidance: MDCG 2024-10 – Clinical evaluation of orphan medical devices.
  • Updated MDCG guidance: MDCG 2022-13 Rev.1 – Designation, re-assessment and notification of conformity assessment bodies and notified bodies.
  • Updated SCHEER guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices
    covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties

 

May 2024:

  • New MDCG guidance: MDCG 2024-6 – Preliminary re-assessment review (PRAR) form template (MDR)
  • New MDCG guidance: MDCG 2024-7 – Preliminary assessment review (PAR) form template (MDR) 
  • New MDCG guidance: MDCG 2024-8 – Preliminary assessment review (PAR) form template (IVDR)
  • New MDCG guidance: MDCG 2024-9 – Preliminary re-assessment review (PRAR) form template (IVDR)
  • Updated MDCG guidance: MDCG 2022-4 rev.2 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD

April 2024:

  • New MDCG guidance: MDCG 2024-4– Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746.
  • New MDCG guidance: MDCG 2024-5 – Guidance on the Investigator’s Brochure content.
  • Updated MDCG guidance: MDCG 2022-9 Rev.1– Summary of safety and performance template.

 

March 2024:

  • New MDCG guidance: MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices.

February 2024:

  • New MDCG guidance: MDCG 2024-2 – Procedures for the updates of the EMDN.

January 2024:

  • Commission proposal to extend the transition periods for certain IVDs, the gradual roll-out of Eudamed and an information obligation in case of interruption of supply.
  • Publication on MDR/IVDR Language requirements – Overview of language requirements for manufacturers of medical devices for the information and instructions that accompany a device in a specific country.
  • New MDCG guidance: MDCG 2024-1 – Device Specific Vigilance Guidance (DSVG) Template.

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