Regulatory Update

March EU Regulation Updates

Stay updated with the latest EU regulations and guidance in the medical device industry. Check out our comprehensive summary of key updates including new standards, legislative acts, and guidance documents. Dive in now to stay compliant and informed!

Published on:
April 5, 2024

March 6th: COMMISSION IMPLEMENTING DECISION (EU) 2024/815

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202400815

The Implementing Decision amended the list of harmonized standards in Europe under MDR with the following:

- EN 455-3:2023: Medical gloves for single use – Requirements and testing for biological evaluation.

- EN ISO 10993-15:2023: Biological evaluation of medical devices – Identification and quantification of degradation products from metals and alloys.

- EN ISO 10993-17:2023: Biological evaluation of medical devices – Toxicological risk assessment of medical device constituents.

- EN ISO 10993-18:2020/A1:2023: Biological evaluation of medical devices – Chemical characterization of medical device materials within a risk management process.

- EN ISO 11137-2:2015/A1:2023: Sterilization of health care products – Radiation – Establishing the sterilization dose.

- EN ISO 11607-1:2020/A1:2023 and EN ISO 11607-2:2020/A1:2023: Packaging for terminally sterilized medical devices – Requirements for materials, sterile barrier systems, packaging systems, and validation requirements for forming, sealing, and assembly processes.

- EN ISO 17664-2:2023: Processing of health care products – Information provided by the medical device manufacturer for processing non-critical medical devices.

The consolidated list of MDR harmonized standards can be found at the following link: https://ec.europa.eu/docsroom/documents/58477/attachments/1/translations/en/renditions/native

March 6th: COMMISSION IMPLEMENTING DECISION (EU) 2024/817

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=OJ:L_202400817

The Implementing Decision amended the list of harmonized standards in Europe under IVDR with the following:

- EN ISO 11137-2:2015/A1:2023: Sterilization of health care products – Radiation – Establishing the sterilization dose.

- EN ISO 11607-1:2020/A1:2023 and EN ISO 11607-2:2020/A1:2023: Packaging for terminally sterilized medical devices – Requirements for materials, sterile barrier systems, packaging systems, and validation requirements for forming, sealing, and assembly processes.

The consolidated list of IVDR harmonized standards can be found at the following link: https://ec.europa.eu/docsroom/documents/58475/attachments/1/translations/en/renditions/native

March 12th: MDCG 2024-3 Guidance on content of the Clinical  Investigation Plan for clinical investigations of medical devices

https://health.ec.europa.eu/document/download/690de85a-ac17-45ea-bb32-7839540c25c4_en?filename=mdcg_2024-3_en_0.pdf

The MDCG guidance document describes the Clinical Investigation Plan (CIP) for clinical investigations of medical devices. This guidance is pivotal for ensuring that clinical investigations are designed based on the latest scientific and technical insights, aiming to confirm the manufacturer's claims about a device's safety, performance, and benefit-risk profile. The document breaks down the essential elements of the CIP, starting from a general introduction that includes the investigation's title, objectives, and considering important requirements such as design of the clinical investigation, statistical analysis, data management, informed consent handling of adverse events, modifications of the CIP, etc., as well as a template of CIP synopsis. The document provides an exhaustive roadmap for sponsors to develop their own CIPs, facilitating the assessments by competent authorities and ethics committee and ensuring the compliance to MDR (especially Annex XV) and ISO14155:2020.

March 13th: Parliament approved the Artificial Intelligence Act

https://www.europarl.europa.eu/doceo/document/TA-9-2024-0138_EN.pdf

The legislation is currently undergoing a final review by legal and linguistic experts and is anticipated to be officially approved before the legislative session concludes. Additionally, a formal ratification by the Council is required and the regulation will become effective 20 days following its publication in the Official Journal.

The AI Act will take effect gradually up to 36 months later. The transition to full applicability of the AI Act involves a phased approach, balancing immediate safety and rights protections with longer-term regulatory adjustments for emerging technologies. High-risk AI systems are subjected to rigorous requirements from the outset, including accurate data use, risk assessment, and transparency. Prohibited practices, such as exploitative use of vulnerabilities and indiscriminate social scoring, are immediately enforceable to protect individuals' rights and societal values. The gradual enforcement allows stakeholders to adapt to new regulations, ensuring AI developments align with EU standards of safety, ethical use, and fundamental rights protection.

The AI Act, as adopted by the European Parliament, introduces a comprehensive framework for the regulation of AI within the EU, aiming to harmonize rules on AI development, deployment, and usage while ensuring safety, fundamental rights, and environmental protection. It categorizes AI systems based on risk, emphasizing stringent requirements for high-risk AI, including transparency, data governance, and human oversight. Prohibited practices include manipulative techniques, social scoring, and unauthorized use of biometric identification.

March: Working instructions for Notified Bodies on the application of Article 54 of Regulation (EU) 2017/745 on medical devices and Article 48 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (Expamed document D5.1)

https://www.ema.europa.eu/en/documents/other/working-instructions-notified-bodies-application-article-54-regulation-eu-2017-745-medical-devices-article-48-regulation-eu-2017-746-vitro-diagnostic-medical-devices_en.pdf

The EMA has released crucial instructions for Notified Bodies concerning the application of Articles 54 (MDR) / 48 (IVDR) on the Clinical/Performance Consultation Procedure.

Manufacturers of Class III implantable devices and Class IIb active devices intended to administer and/or remove a medicinal product (unless specific exemption criteria are fulfilled (MDR Article 54(2))) as well as for first certification of Class D devices where no Common Specifications (CS) are available, the NBs are required to consult the expert panel to obtain a scientific opinion.

These procedures involve a step-by-step workflow for Notified Bodies, starting from determining if a device qualifies for consultation, through the uploading of relevant documentation onto the CIRCABC platform, to the consideration of expert panel opinions in the conformity assessment. The instructions detail the documents required, the marking of sensitive information, and the responsibilities of the Secretariat in managing the consultation process. The guidance aims to ensure the efficient and secure transmission of documents, while also outlining the publication of expert panel opinions and the handling of commercially confidential information.

March: Ongoing/planned guidance development and deliverables of MDCG Subgroups – March 2024

https://health.ec.europa.eu/document/download/f588a5c8-57af-48aa-808f-1d9c02f4925a_en?filename=mdcg_ongoing-guidance_0.pdf

The following are the key new/updated MDCG guidance documents in:

Q1 2024

- Update of the MDCG 2019-9 - Rev.1 Summary of safety and clinical performance

- Guidance on content of Investigator’s Brochure for clinical investigations conducted under (EU) regulation 2017/745

Q2 2024

- Update MIR form

- Guidance on Post-Market Surveillance

- MDR Vigilance guidance on implementation of Articles 87 to 90 MDR

- Revision of Trend report and related documents

Q3 2023

- Update of Field Safety Corrective Action form  

- Extension of PSUR guidance for IVDR  

2024

- Notified Body Technical Documentation Assessment Report

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