Sushvin Consultancy Services Medical Devices Industry Updates Newsletter February 2024

Sushvin Consultancy Services has undertaken an initiative to start a monthly newsletter since April 2023 to provide latest updates from pharmaceutical and medical devices industry.

This will enable us to educate industry participants of latest happening, changes or updates to standards, guidance and regulations. As a part of this initiative, this month’s newsletter will cover updates from medical devices industry for the month of February 2024.

#uk #usfda #europeancommission #mhra #imdrf #mdcg #india #mda #tga #healthcanada #iso #swissmedic

There have been few updates in the month of February 2024. These are as follows:

ISO Updates:

• ISO 80601-2-55:2018/Amd 1:2023Medical electrical equipmentPart 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitorsAmendment 1
• ISO 11979-7:2024Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia
• ISO 11139:2018/Amd 1:2024Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards - Amendment 1: Amended and additional terms and definitions
• ISO/TS 5499:2024Health informatics - Clinical particulars - Core principles for the harmonization of therapeutic indications terms and identifiers
• ISO/TS 14265:2024Health informatics - Classification of purposes for processing personal health information

IMDRF Updates:

• A Proposed Document by the International Medical Device Regulators Forum (IMDRF), Software as a Medical Device Working Group, is provided below for public comment.https://www.imdrf.org/consultations/medical-device-software-considerations-device-and-risk-characterizationConsultation open: Medical Device Software: Considerations for Device and Risk CharacterizationStart date?Friday, 2 February 2024Closing date?Thursday, 2 May 2024Working group:?Software as a Medical Device (SaMD)The objective of this document is to promote and inform clear and accurate characterizations of medical device software (including intended use/intended purpose statements) and introduce a general strategy for characterizing software-specific risks that leverages the key features of a comprehensive medical device software characterization.This document is intended to:? Highlight the importance of comprehensive characterizations for medical device software;? Establish key features of and common vocabulary for the characterization of medical device software;? Identify fundamental elements of an intended use/intended purpose statement for medical device software;? Establish links between characterization features and risk for medical device software;? Provide information for consideration during the identification and assessment of medical device software risks.Thank you for your contribution in reviewing and providing feedback for this document. Please use the comments template: https://lnkd.in/gzPHrYSA - to provide comments on the Proposed Document and send comments to email:?[email protected]?with the subject line ''Public Consultation on Medical Device Software: Considerations for Device and Risk Characterization"

Sushvin Provides UK Responsible Person (UK RP) Services

Are you a legal medical device/IVD manufacturer located outside the UK and would like to market your product in the UK, then you will require a UK responsible person who will act on behalf of the manufacturer to ensure all the responsibilities detailed within the updated UK MDR 2002 regulations are met.

As a legal manufacturer, organisations will have to register their devices prior to be placed on the UK market.

If you need UK Responsible Person (UK RP) services, please contact SUSHVIN for more information.

Sushvin Provides PRRC (Person Responsible for Regulatory Compliance) Services

If you are planning to market your product in the EU and if you require PRRC (Person Responsible for Regulatory Compliance), we have a team of experienced regulatory professionals who can help you assist with PRRC services and get you regulatory compliant as per MDR 2017/745 and IVDR 2017/746

If you need PRRC Services, please contact SUSHVIN for more information.

UK Updates:

• Medicines and Healthcare products Regulatory Agency released their MedRegs blog on Med Tech Regulatory Reform: The first steps towards a new framework for medical devices in the UK. 13 February 2024https://lnkd.in/eV5SqCBuIn the first of a new blog series, Laura Squire, Med Tech Regulatory Reform Lead and Chief Officer Healthcare, Quality and Access, shares an update on the MHRA’s progress towards implementing the regulatory changes set out in the Roadmap (Published by MHRA on 9 January 2024).I’d like 2024 to be a year of transparency. This blog series is part of that and as we work through to deliver our Roadmap, there will be more. Our priority is patient safety and we know we need to work in partnership with our stakeholders to achieve that. - Laura SquireRoadmap weblink: https://lnkd.in/d-6y6BtG

EU Updates:

• Medtech Europe Published:Joint statement supporting the expansion of the use of Electronic Instructions For Use in the medical devices sectorMedTech Europe, together with 11 organisations, asks the Medical Device Coordination Group (MDCG) to consider the scope extension of Commission Implementing Regulation (EU) 2021/2226 on electronic Instructions for Use (eIFU) a priority for 2024.Expanding a scope of this regulation via a targeted update will allow for a level playing field, help equity of access to medical devices across the EU and thereby support efficient MDR implementation.https://lnkd.in/d5rPcFEs.For more information – allowing all medical devices used by healthcare professionals to be accompanied by IFU in an electronic format – please consult Medtech Europe's latest position paper here:https://lnkd.in/eRY6JdXj
• Medical Device Coordination Group Published Document:MDCG 2024-2 Procedures for the updates of the European Medical Device Nomenclature February 2024The European Medical Device Nomenclature (EMDN), as established by Article 26 of Regulation (EU) 2017/745 – Medical Device Regulation (MDR) and Article 23 of Regulation (EU) 2017/746 - In Vitro Diagnostic medical devices Regulation (IVDR), will be annually reviewed and updated based on the practical use of the EMDN and feedback from its users. This document lays out the procedures for the annual revision as well as the procedure for ad-hoc requests requiring an expedited review.https://lnkd.in/eQJ7zvz9
• European Commission Published EUDAMED user guide UDI Devices. Production v 2.14 2024Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnosis medical devices introduce an EU identification system for medical devices based on a Unique Device Identifier (UDI). The UDI-DI/Device module of EUDAMED is used for the manufacturers to provide their UDIs/Devices information and to make it available to everyone.https://lnkd.in/dRiaDZ3Y
• European Commission Publishes - EUDAMED user guide Economic Operators – Actor module.?Production v 2.14 2024EUDAMED is the IT system developed by the European Commission to implement the EU medical devices regulations: Regulation 2017/745 on medical devices Regulation, 2017/746 on in vitro diagnosis devices.EUDAMED is structured around six interconnected modules and a public site:? Actor – user registration and management? UDI database and registration of devices? Certificates and Notified Bodies? Clinical Investigation and performance studies? Vigilance and post-market surveillance? Market surveillancehttps://lnkd.in/dA6dHs5Y
• European CommissionNews announcement. 22 February 2024. Directorate-General for Health and Food Safety -Expression of interest open – Possible second call for EU reference laboratories for high-risk in vitro diagnostic medical deviceshttps://lnkd.in/d_3_8yszThe Commission, after consulting the Member States in the?Medical Device Coordination Group, is considering launching a second call to cover the remaining categories of class D devices:ArbovirusesHaemorrhagic fever and other biosafety level 4 virusesParasitesBlood groupingInterested laboratories are invited to informally express interest to their Member State by 30 April 2024.Background on EU reference laboratories in the field of IVDs:EU reference laboratories in the field of IVDs are designated to perform important tasks outlined in Article 100 of?Regulation (EU) 2017/746. EURLs verify the performance of class D devices and compliance with common specifications and they perform batch testing of class D devices in response to requests by notified bodies.More information can be found on the?EU reference laboratories (EURLs) page: https://lnkd.in/dWjXzer3
• The European Association of Medical devices Notified Bodies - Team-NB Publishes Position Paper on SARS-CoV-2 ClassificationAdoption date 21/02/2024Team-NB Notified Bodies recommendations on the classification of devices intended to detect the presence or the exposure to SARS-CoV-2https://www.team-nb.org/team-nb-documents/Background information:SARS-CoV-2 devices are currently classified as class D devices according to MDCG Classification guidance 2020-16 Rev. 2 per IVDR Annex VIII Rule 1, 2nd indent.Rule 1 second indent:Devices intended to be used for the detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation.NOTE 2: The list of high-risk agents may be updated based on quantitative analysis of new scientific evidence on the incidence, pathogenicity, burden of mortality and morbidity, and transmission dynamics of infectious agents in the population.”MDCG 2020-16 rev2 “Guidance on Classification Rules for in vitro Diagnostic Medical Devices under Regulation (EU) 2017/746” provides further explanation and guidance of the classification rules outlined in Annex VIII IVDR. MDCG 2020-16 rev2 lists in its rationale, SARS-CoV-2 devices as examples for Class D devices falling under Rule 1 second indent “Devices intended to be used for the detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation”.According to rule 1 second indent two main aspects need to be considered (and fulfilled) in combination:1. High or suspected high risk of propagation.2. Causes a life-threatening disease.The rationale obtains respective considerations related to potential dynamics regarding incidence, transmission, pathogenicity, mortality and morbidity based on a quantitative analysis of new scientific evidence for the relevant infectious agents, hence the two main aspects of rule 1 second indent; first “high or suspected high risk of propagation” and second “causes a life threatening disease” might be weighted differently using new scientific data which might lead into a change of the classification (Note 2 page 17 of MDCG 2020-16 rev2).

Sushvin Provides UK Responsible Person (UK RP) Services

Are you a legal medical device/IVD manufacturer located outside the UK and would like to market your product in the UK, then you will require a UK responsible person who will act on behalf of the manufacturer to ensure all the responsibilities detailed within the updated UK MDR 2002 regulations are met.

As a legal manufacturer, organisations will have to register their devices prior to be placed on the UK market.

If you need UK Responsible Person (UK RP) services, please contact SUSHVIN for more information.

Sushvin Provides PRRC (Person Responsible for Regulatory Compliance) Services

If you are planning to market your product in the EU and if you require PRRC (Person Responsible for Regulatory Compliance), we have a team of experienced regulatory professionals who can help you assist with PRRC services and get you regulatory compliant as per MDR 2017/745 and IVDR 2017/746

If you need PRRC Services, please contact SUSHVIN for more information.

USFDA Updates:

• DEPARTMENT OF HEALTH AND HUMAN SERVICES, Final RuleFood and Drug Administration21 CFR Parts 4 and 820[Docket No. FDA–2021–N–0507]RIN 0910–AH99 Medical Devices;Quality System Regulation AmendmentsA Rule by?the?Food and Drug Administration?on?02/02/2024FDA has historically recognized the benefits of harmonization with other regulatory authorities and, over time, has taken a number of actions to promote consistency with its regulatory counterparts. As part of such activities, FDA is revising its medical device CGMP requirements as set forth in the QS regulation, codified in part 820 (21 CFR part 820). FDA is accomplishing this primarily by incorporating by reference the 2016 edition of ISO 13485 (ISO 13485). Through this rulemaking, FDA is harmonizing quality management system requirements for medical devices with requirements used by other regulatory authorities.This rule is effective February 2, 2026. The incorporation by reference of certain material listed in this rule is approved by the Director of the Federal Register February 2, 2026.

Canada Updates:

• Government of Canada Publishes:Draft guidance on how to interpret ‘significant change’ of a medical device: OverviewReplaces:?Guidance for the Interpretation of Significant Change of a Medical Device?(2011)This guidance document has been updated to expand on the definition of “significant change” in the?Medical Devices Regulations?(regulations). This will help you determine whether a change proposed to a Class III or IV medical device is significant.Medical devices are classified into 1 of 4 risk classes (I to IV). The classification rules are set out in Schedule I of the regulations.According to these rules, Class I is the lowest risk and Class IV is the highest risk. All Class II, III and IV medical devices sold or imported for sale in Canada must be licensed under Part 1, Section 26 or authorized under Part 1.1 of the regulations.Note: References to an authorization or a device as an authorized device mean a license or a device licensed under Part 1 or an authorization or a device authorized under Part 1.1 of the regulations.https://lnkd.in/e76_huT8
• Health Canada invites you to provide feedback on the overall clarity and content of the?draft guidance on how to interpret ‘significant change’ of a medical device.Opened on February 7, 2024, and will close to new input on April 22, 2024.https://lnkd.in/edy2vXq9

Sushvin Provides UK Responsible Person (UK RP) Services

Are you a legal medical device/IVD manufacturer located outside the UK and would like to market your product in the UK, then you will require a UK responsible person who will act on behalf of the manufacturer to ensure all the responsibilities detailed within the updated UK MDR 2002 regulations are met.

As a legal manufacturer, organisations will have to register their devices prior to be placed on the UK market.

If you need UK Responsible Person (UK RP) services, please contact SUSHVIN for more information.

Sushvin Provides PRRC (Person Responsible for Regulatory Compliance) Services

If you are planning to market your product in the EU and if you require PRRC (Person Responsible for Regulatory Compliance), we have a team of experienced regulatory professionals who can help you assist with PRRC services and get you regulatory compliant as per MDR 2017/745 and IVDR 2017/746

If you need PRRC Services, please contact SUSHVIN for more information.

Australia (TGA) Updates:

• Australia - Therapeutic Goods Administration Publishes Essential Principles Checklist (medical devices) Under Guidance and resourcesIt is the manufacturer's responsibility to?demonstrate compliance with the Essential Principles?for their medical devices.https://lnkd.in/e3_FHpVpManufacturers must generate, collate, assess, and maintain scientific and clinical evidence that shows that their devices comply with the Essential Principles. The evidence must be relevant to the device's intended purpose and must be objective, sufficient, and robust.? The Essential Principles Checklist is a template that may help you:– identify the safety and performance requirements that apply to your device – document a rationale for any of the safety and performance requirements that aren't relevant– summarise the evidence you hold in support of each of the relevant safety and performance requirements? Completing the checklist could help you:– apply for an Australian conformity assessment certificate– comply with regulations as part of a post-market review or investigation– to determine if you have considered and addressed all the requirements with supporting evidence
• Therapeutic Goods Administration, Australia Publishes Guidance on Medical Device Labelling Obligations- Learn how medical device labelling requirements help manufacturers and sponsors fulfil their responsibilities.Labelling means the labels and information that come with a medical device.All medical devices in Australia must meet safety and performance standards. The Regulations state that medical devices must include information like labels and instructions.https://lnkd.in/dVxbwm_5
• Therapeutic Goods Administration, Australia Publishes Australian declaration of conformity templates (IVDs)- Australian Declarations of Conformity templates for in vitro diagnostic deviceshttps://www.tga.gov.au/how-we-regulate/manufacturing/manufacture-medical-device/obtain-and-maintain-regulatory-evidence/tga-conformity-assessment/resources/resource/forms/australian-declaration-conformity-templates-ivdsAs part of the conformity assessment procedures, the manufacturer of an IVD medical device is required to make a Declaration of Conformity which declares that the device complies with:- the applicable provisions of the Essential Principles- the classification rules- an appropriate conformity assessment procedureThe declaration also requires the manufacturer to provide details that are relevant to the conformity assessment procedure and the manufacture of the IVD medical device covered by the declaration.It should be noted that these templates are published to assist in the preparation of declarations of conformity. It is the responsibility of the manufacturer signing a declaration to ensure that it is drawn up correctly and meets all the legal requirements.

Switzerland Updates:

• Swissmedic Publishes Information sheet on MDS requirements for corrective and preventive action plansIdentification number: IN640_00_001Version: 2.0Valid from: 01.02.2024https://lnkd.in/djTVQAM7When deviations from legal requirements (non-conformities) are identified at an economic operator in the course of market surveillance by authorities (e.g. an inspection), Swissmedic requests submission of a written corrective and preventive action plan (“CAPA plan”) for their rectification.This information sheet is intended to support economic operators of medical devices in the development of a CAPA plan and summarises basic content requirements.

Sushvin Provides UK Responsible Person (UK RP) Services

Are you a legal medical device/IVD manufacturer located outside the UK and would like to market your product in the UK, then you will require a UK responsible person who will act on behalf of the manufacturer to ensure all the responsibilities detailed within the updated UK MDR 2002 regulations are met.

As a legal manufacturer, organisations will have to register their devices prior to be placed on the UK market.

If you need UK Responsible Person (UK RP) services, please contact SUSHVIN for more information.

Sushvin Provides PRRC (Person Responsible for Regulatory Compliance) Services

If you are planning to market your product in the EU and if you require PRRC (Person Responsible for Regulatory Compliance), we have a team of experienced regulatory professionals who can help you assist with PRRC services and get you regulatory compliant as per MDR 2017/745 and IVDR 2017/746

If you need PRRC Services, please contact SUSHVIN for more information.

• Medical device Authority, Ministry of Health Malaysia Published:SECOND EDITION GUIDANCE DOCUMENT MDA/GD/0005: GENERAL MEDICAL DEVICE - GROUPINGhttps://lnkd.in/d_5JYKsMThis Guidance Document was prepared by the Medical Device Authority (MDA) to help the industry and healthcare professionals in their quest to comply with the Medical Device Act (Act 737) and the regulations under it.This guidance document is updated to provide guidance to determine the appropriate grouping for medical devices in the medical device registration application and separate the grouping requirements for IVD medical devices.This Guidance Document shall be read in conjunction with the current laws and regulations used in Malaysia, which include but not limited to the following-1. Medical Device Act 2012 (Act 737);2. Medical Device Regulations 2012;3.The Medical Device (Advertising) Regulations 2019; and4. The Medical Device (Duties and Obligations of Establishments) Regulations 2019

India Updates:

• BUREAU OF INDIAN STANDARDS RELEASES DRAFT FOR COMMENTS ONLYSPECIFICATION FOR PETROLEUM JELLY FOR COSMETIC INDUSTRY (Second Revision of IS 4887) (ICS 71.100.70)Doc. No.: PCD 19 (24649) WC December 2023Cosmetics Sectional Committee, PCD 19Last date for Comments: 12 March 2024This standard prescribes the requirements and methods of sampling and test for petroleum jelly for cosmetic industry.

Sushvin Provides UK Responsible Person (UK RP) Services

Are you a legal medical device/IVD manufacturer located outside the UK and would like to market your product in the UK, then you will require a UK responsible person who will act on behalf of the manufacturer to ensure all the responsibilities detailed within the updated UK MDR 2002 regulations are met.

As a legal manufacturer, organisations will have to register their devices prior to be placed on the UK market.

If you need UK Responsible Person (UK RP) services, please contact SUSHVIN for more information.

Sushvin Provides PRRC (Person Responsible for Regulatory Compliance) Services

If you are planning to market your product in the EU and if you require PRRC (Person Responsible for Regulatory Compliance), we have a team of experienced regulatory professionals who can help you assist with PRRC services and get you regulatory compliant as per MDR 2017/745 and IVDR 2017/746

If you need PRRC Services, please contact SUSHVIN for more information.