Medical Devices – USA, Europe, Asia and ROW Regulatory News – Mar. 2024

April 3, 2024 | Medical Device

USA

Accreditation Scheme for Conformity Assessment (ASCA)

The Center for Devices and Radiological Health’s (CDRH) Division of Standards and Conformity Assessment (DSCA) encourages medical device sponsors to use FDA-recognized voluntary consensus standards in their product submissions, as conformity to relevant standards both reduces regulatory burden and fosters quality.

The FDA is implementing ASCA in accordance with:

Amendments made to Section 514(d) of the Federal Food, Drug & Cosmetic Act by the Food and Drug Omnibus Reform Act of 2022, and
The Medical Device User Fee Amendments of 2022 (MDUFA V).

If we would like to receive notifications about ASCA, email ASCA@fda.hhs.gov

U.S. Food and Drug Administration (FDA) issued Update on Artificial Intelligence and Machine Learning in Software as a Medical Device

The paper describes four areas of focus for CBER, CDER, CDRH, and OCP regarding the development and use of AI across the medical product life cycle.

CBER, CDER, CDRH and OCP plan to tailor their regulatory approaches for the use of AI in medical products to protect patients and health care workers and ensure the cybersecurity of medical products in a manner that promotes innovation.

EUROPE

European Commission requests scientific opinion on classification of brain stimulators

The European Commission has asked an advisory committee for a scientific opinion on the risks to health posed by brain stimulators without an intended medical purpose.

The Medical Device Regulation (MDR) describes the devices as equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain. In 2022, six member states asked that such devices to be moved from class I to class III. The request was informed by evidence generated after the adoption of MDR.

The Commission wants SCHEER to identify any hazards and risks, look at the potential for permanent modifications of the structure or functioning of the brain, and “determine if and under what conditions the administration of energy to the human body is made in a potentially hazardous way.” SCHEER has until the end of 2025 to adopt a final scientific opinion.

European Commission proposes updates to medical device phthalates guidelines

The proposed update was published on 21 March by the Commission and its Scientific Committee on Health, Environmental and Emerging Risks (SCHEER). The guidelines must be updated every five years under the EU Medical Devices Regulation (MDR). (RELATED: EU Drafts Guidance on Assessing the Benefits and Risks of Phthalates, Regulatory Focus 28 March 2019).

“Following a request from the European Commission, SCHEER provided the first update of the guidelines on the benefit-risk assessment of phthalates in medical devices specified in the mandate, which have one or more of the following properties: carcinogenic, mutagenic, toxic to reproduction (CMR) or endocrine-disrupting (ED),” the Commission said.

The guidelines also detail the methodology medical device manufacturers should use to perform risk-benefit analysis to justify keeping certain CMR/ED phthalates over the 0.1% threshold in their products or parts that make up their products. The Commission also noted that the document can be used to evaluate the risk-benefit of other CMR/ED chemicals in medical devices.

Overview of language requirements for manufacturers of medical devices

Regulation (EU) 2017/745 on medical devices (MDR) contains different legal provisions that allow Member States to determine language requirements for manufacturers at national level for information accompanying the device. The following table gives an overview of the national provisions, in the case that Member States have made use of the possibility to determine language requirements for manufacturers. Member States are not obliged to determine a specific language. Having regard to the costs related to providing information in various languages, Member States are encouraged to consider whether information to be provided by the manufacturer could be accepted in another language than their national language (e.g. in English) if the safe use of the device is not compromised, especially regarding devices for professional use.

EPA finalizes rule to reduce EtO emissions from sterilization facilities

EPA announced final amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Ethylene Oxide Commercial Sterilizers. Since 2019, EPA has been gathering information about how to reduce people’s risk from exposure to ethylene oxide (EtO). This rule is one of the most important measures EPA is taking to reduce emissions of EtO while mitigating and managing any potential supply chain impacts. The Clean Air Act standards EPA is finalizing will reduce lifetime cancer risks associated with EtO emissions from commercial sterilizers down to or below the benchmark of 100 cancer cases per million people exposed. And the number of people with a potential risk of greater than or equal to one in one million will be reduced by approximately 92 percent.

European Commission adopts harmonized standards for medical device sterilization

The European Commission has adopted implementing decisions on harmonized standards for sterilized medical devices.

Under the EU medical device and in vitro diagnostic (IVDs) regulations, products that conform to harmonized standards are presumed to meet the relevant regulatory requirements. The Commission asked other EU bodies to draft new harmonized standards to support the regulations, resulting in documents about the sterilization of a range of medical devices and diagnostics.

Officials have ruled that the proposed standards satisfy the requirements, leading the Commission to create two implementing decisions. One decision adds three standards related to sterilization to an annex of an existing document about IVDs. The other document adds the sterilization standards, plus other texts about medical gloves and more, to the annex of an existing decision on medical devices.

MDCG 2024-3 – Guidance on content of the Clinical Investigation Plan for clinical investigations of medical devices

When a sponsor of a clinical investigation submits an application according to article 70(1) of the MDR, to the Member State(s) in which the clinical investigation is to be conducted, the application shall be accompanied by the documentation referred to in Chapter II of Annex XV of the MDR.

According to section 2 of Chapter I of Annex XV of the MDR, clinical investigations shall be performed on the basis of an appropriate plan of investigation reflecting the latest scientific and technical knowledge, and defined in such a way to be able confirm or refute the manufacturer’s claims regarding the safety, performance and aspects relating to the benefit-risk determination of devices. The clinical investigation shall include an adequate number of observations to guarantee the scientific value and validity of the conclusions. The procedures and research methodologies used to perform the clinical investigation shall be appropriate to the device under investigation.

AUSTRALIA

Guidance on Supporting documentation for inclusion of a medical device

The guidance aims to help sponsors identify the relevant documentation that will assist them throughout the application, inclusion and post-market processes associated with maintaining a device inclusion in the ARTG.

The information must be provided in addition to the Manufacturer Evidence for Medical Devices (including IVDs) that you submitted to the TGA prior to commencing your device application. The specific documents that you are required to attach are outlined in the final column “Documentation to be provided with the application (Evidence of product assessment)” in the Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs).

BRAZIL

Regulation update: Anvisa updates safety and performance requirements for medical devices

The new resolution revises RDC 546/2021, which replaced the previous standard (RDC 56/2001).

The updated essential safety and performance requirements will allow the regulatory authority to evaluate these aspects against new technologies and the diversity of medical devices. The updated requirements will also enable manufacturers to identify the studies and evidence that should support product registration requests in an objective manner, giving more robustness to the documentation submitted to Anvisa.

Anvisa extends the validity period of the Good Manufacturing Practices Certificate to four years

The validity of the Certificate of Good Manufacturing Practices (CBPF) for medical device manufacturers granted through the MDSAP (Medical Device Single Audit Program) was extended from two to four years.

CANADA

Guidance on Regulatory enrolment process (REP)-Medical devices

The Regulatory Enrolment Process (REP) facilitates the filing and processing of regulatory information related to:

Company
Dossier and product
Regulatory activity
Regulatory transaction

This process enables a move towards a common submission intake across product lines and allows Health Canada to:

Receive a broader range of regulatory information via the Common Electronic Submission Gateway (CESG)
Automate the import of regulatory transactions into its repositories

CHINA

Notice on collecting information from relevant companies and units participating in the preparation of three in vitro diagnostic reagent registration review guidelines including the “Human KRAS Mutation Gene Detection Reagents (PCR Method) Registration Review Guidelines”

According to the 2024 guiding principles, the plan is prepared. In order to further improve the technical review work of related products, the center has now launched the “Guiding Principles for Registration Review of Human KRAS Mutation Gene Detection Reagents (PCR Method)” and “Glucose-6-phosphate Dehydrogenase” Preparation of “Guiding Principles for Registration Review of Testing Reagents” and “Guiding Principles for Traceability Registration Review of Enzyme Testing Reagents”. Units participating in the preparation work are now being solicited, and domestic and foreign production companies, scientific research institutions, clinical institutions, etc. with relevant work experience are invited to actively participate.

Units interested in participating in the preparation work are requested to fill in the participating unit information collection form (attachment) and submit it to our center in electronic form before March 29, 2024. Please name the email subject in the format of “XX Guiding Principles + Unit Name”.

Notice on soliciting information from relevant companies and units participating in the preparation of two in vitro diagnostic reagent registration review guidelines including the “Registration Review Guidelines for Human T Lymphocytic Leukemia Virus Antibody Detection Reagents”

According to the 2024 guiding principles preparation plan, in order to further improve the technical review work of related products, our center has now launched the “Guiding Principles for Registration Review of Human T Lymphocyte Leukemia Virus Antibody Detection Reagents” and “Human Leukocyte Antigen (HLA) Gene DNA” Preparation of “Guiding Principles for Registration Review of Typing Test Reagents”. Units participating in the preparation work are now being solicited, and domestic and foreign production companies, scientific research institutions, clinical institutions, etc. with relevant work experience are invited to actively participate.

Units interested in participating in the preparation work are requested to fill in the participating unit information collection form (attachment) and submit it to our center in electronic form before March 29, 2024. Please name the email subject in the format of “XX Guiding Principles + Unit Name”.

Notice from the Device Review Center of the State Food and Drug Administration on the release of the Guiding Principles for Registration Review of High-Frequency Surgical Equipment (2023 Revised Version)

The guideline applies to high-frequency surgical equipment. According to the definition of 201.3.224 in the GB 9706.202 standard, high-frequency surgical equipment mentioned in this guideline refers to “medical electrical equipment that generates high-frequency current and is expected to use high-frequency current for surgical operations, such as cutting (cutting) biological tissue or solidification)”. It with special clinical use methods or specific indications (such as plasma surgical equipment, large vessel closure equipment, etc.).

The guideline does not apply to radiofrequency ablation equipment for gynecology, oncology or heart, as well as non-ablative radiofrequency treatment equipment that uses radiofrequency energy for plastic surgery/beauty. It does not apply to electric heating and cauterization equipment and hyperthermia products. It does not include the requirements for surgical accessories and neutral electrodes in high-frequency accessories. If the structural composition contains surgical accessories and neutral electrodes.

Interpretation of “Guiding Principles for Medical Device Usability Engineering Registration Review”

The guiding principles apply to registration applications for Class II and Class III medical device availability projects, but do not apply to in vitro diagnostic reagents. Registration applicants can refer to the guiding principles to carry out usability engineering work for all medical devices.

Medical device usability engineering refers to the comprehensive use of knowledge about human anatomy, physiology, psychology, behavior, culture and other aspects of capabilities and limitations to design and develop medical devices to enhance the usability of medical devices.

Usability refers to the user interface features that ensure the safety, effectiveness and ease of use of medical devices when users are expected to use the medical devices normally under expected usage scenarios. The core elements of usability include users, usage scenarios and user interfaces, focusing on the safety and effectiveness of normal use of medical devices.

Notice on collecting information from relevant enterprises and units participating in the preparation of six guiding principles including the “Guiding Principles for Registration and Review of Metal Bone Needles”

Participating unit information collection form and units participating in the preparation of Guidelines for registration review of metal bone needles, memory alloy rib plates, Skull Repair Mesh System, sternum strapping/grasp fixation system, Filling Materials for Oral Hard Tissue and Dental Resin Filling Material Products (2024 Revised Edition).

Notice of the Device Review Center of the State Food and Drug Administration on the release of guiding principles for registration review of medical device availability engineering

The guiding principle applies to registration applications for Class II and Class III medical device availability projects, but does not apply to in vitro diagnostic reagents. Registration applicants may refer to this guideline to carry out usability engineering work for all medical devices.

It is formulated based on current regulations, mandatory standard systems, and current scientific and technological capabilities and cognitive levels. With the continuous improvement of regulations and mandatory standard systems and the continuous development of scientific and technological capabilities and cognitive levels, these guiding principles are relevant The content will also be adjusted in due course.

It is guidance document for registration applicants, reviewers and inspectors. It does not involve administrative approval matters, nor is it enforced as a regulation. This guiding principle should be used under the premise of complying with relevant regulations.

Notice from the Device Review Center of the State Food and Drug Administration on the release of the guiding principles for the registration review of four medical devices including corneal topographs

The guideline applies to equipment that uses the working principle of optical imaging/measurement to obtain the shape of the cornea surface through non-contact methods. According to the 2017 version of the “Medical Device Classification Catalog”, this type of equipment is managed as Class II medical devices, covering applicable products with a classification code of 16-04-12.

The guideline applies to the design and implementation of animal experiments on multiport laparoscopic surgical systems. It is intended to guide registered applicants to scientifically conduct animal experimental research on surgical systems. It is not applicable to experiments conducted on non-living animals, isolated tissues or organs. Research.

The guideline applies to three-dimensional endoscopes in multiport laparoscopic surgery systems. It is applicable to those with a robotic arm interface that can be installed on the robotic arm and controlled by the system. Special endoscopes are also suitable for general endoscopes that can be used independently without being controlled by a robotic arm.

The guideline applies to medical devices whose products contain light sources (including laser and non-laser), and the light emitted by the light source is expected to act on the human body. It includes both medical devices that use light sources to achieve their main intended use, such as endoscope cold light sources, laser surgical equipment, etc.

Notice of the Device Evaluation Center of the State Food and Drug Administration on the release of the recommended path for clinical evaluation of products related to the medical device classification catalog (supplement in 2024)

In 2024, based on the latest product development and application status, clinical evaluation regulatory scientific research results and technical review work practices, the clinical status of surgical navigation systems, isolated organ mechanical perfusion and transfer equipment, plastic implant wires and other products will be further clarified Evaluate recommended paths.

CZECH REPUBLIC

Updating the process of requesting access to ISZP

The section for the regulation of medical devices proceeded to re-evaluate the requirements of applications for access to the ISZP.

The request for access is available at SÚKL Access (sukl.cz)

FINLAND

The new website provides information on marketing requirements for medical devices

New EU regulations and updated national legislation have brought new requirements to the marketing of medical devices. Fimea has put together a condensed information package on the marketing rules for medical devices in Finland on its new website. The website provides information on the marketing requirements for medical device operators presented in EU regulations and national legislation.

Information can be found on the website:

On regulations concerning the marketing of medical devices
On national requirements for marketing
Marketing claims
Tips for successful marketing of medical devices.

Maintenance is an essential part of the safe use of a medical device

The safety and development center for the pharmaceutical industry, Fimea, has observed negligence in the maintenance of medical devices in connection with the handling of dangerous situations and inspections of professional users.

Following the instructions of the medical device manufacturer is essential to ensure the safe use of the devices throughout their life cycle. The Act on Medical Devices (719/2021) has given obligations to the professional user and professionals performing installation and maintenance work.

The manufacturer’s instructions for the maintenance of medical devices may, for example, contain restrictions on the materials, parts and components used and the qualifications of the person performing maintenance-related activities. Maintenance also includes fulfilling the obligations given by possible manufacturers in the safety data sheets.

GERMANY

Frequently asked questions (FAQ) Changes due to DigiG

A central concern of DigiG is the further development of the provision of digital health applications (DiGA). DiGA should be better integrated into care processes and also enable more complex treatment processes. The following FAQ contains answers to the most important changes related to DiGA.

HONG KONG

The Code of Practice “Code of Practice for Listed Distributors of Medical Devices” (COP-05) has been issued

The purpose of this document is to stipulate the requirements which the Listed Distributor of medical devices has to comply with.

Distributors are listed on the List of Distributors by their names, telephone numbers, addresses and Listing Numbers.

The Listed Distributor needs to demonstrate its ability to provide medical devices under the Medical Device Administrative Control System (MDACS) requirements.

This document should be read in conjunction with Guidance Note GN-09 (Guidance Notes for Listing of Distributors of Medical Devices).

Not including custom-made medical device in the scope of Medical Device Administrative Control System (MDACS)

Starting from 2 April 2024, custom-made medical devices are not included in the scope of the MDACS. Please refer to Guidance Notes GN-00 for the relevant definitions and Clause 3.2.1 of the Guidance Notes GN-01 for details.

Announcement of the acceptance of marketing approvals obtained from the Health Sciences Authority (HSA) of Singapore under the Medical Device Administrative Control System (MDACS)

Starting from 2 April 2024, the Medical Device Division (MDD) accepts the marketing approvals obtained from the Health Sciences Authority (HSA) of Singapore as a support of compliance of medical device to the “Essential Principles of Safety and Performance of Medical Devices” (Technical Reference: TR-004) under MDACS.

JAPAN

Publication of foreign manufacturer certification/registration number

Note: A person who is deemed to have been registered as a foreign manufacturer of in vitro diagnostic reagents pursuant to Article 7 of the Supplementary Provisions of the Act for Partial Amendment of the Pharmaceutical Affairs Law, etc. (Act No. 84 of 2013) shall have a registration number. and the certification number according to the Pharmaceutical Affairs Law before the revision. In addition, for the registration number of a person who is deemed to have been registered as a foreign manufacturer of medical devices pursuant to the same article, the certification number before the amendment is to be used.

Publication of foreign manufacturer certification/registration number

Certification or renewal of certification of foreign manufacturers of medical devices is based on the completion of the processing of certification, registration, renewal, addition or change of classification, notification of change, and notification of abolition as of the date of publication, and each time when applying for certification, registration, manufacturing and sales approval, etc. Manufacturers and distributors who import pharmaceuticals, medical devices, etc. into Japan are requested to confirm the certification/registration status directly with the foreign manufacturer concerned.

MALAYSIA

Medical Device (Exemption) Order 2024

1. Exemption from medical device registration

2. Exemption from establishment license

3. Exemption from conformity assessment for Class A medical devices

4. Cancellations and exceptions

MEXICO

Mexico joins the highest international forum of medical device regulators

The Federal Commission for the Protection against Health Risks (Cofepris) announces the incorporation of Mexico as an affiliate member of the International Medical Device Regulators Forum (IMDRF).

Mexico’s participation in the forum will allow normative convergence in regulatory matters to facilitate international trade in health supplies and reduce technical barriers in distribution.

PHILIPPINES

FDA Circular No.2021-021-A || Extension of the Transitory Provision of FDA Circular No. 2021-021 Entitled “Guidelines on the Licensing of Retailers of Medical Devices in the Philippines” for FDA Licensed Manufacturers, Traders or Distributor (Importers, Exporters and/or Wholesalers) of Medical Devices that Also Sell or Intend to Sell Medical Devices to the General Public

Section IX of FC No. 2021-021 is amended to include the following provisions:

1. The filing of LTO variation application of FDA-licensed manufacturers that sell or intend to sell medical devices directly to the general public pursuant to FC No. 2021-021 is hereby extended until the migration of the online licensing application process from the ePortal System to the eServices Portal System has been completed for the said establishments.

2. Whereas, FDA-licensed traders or distributors of medical devices that sell or intend to sell directly to the general public may apply for variation (additional activity) of their existing LTO through the eServices Portal System (https://eservices.fda.gov.ph/) following the provisions of AO No. 2020-0017, FC No. 2021-021, and FC No. 2021-014 . FDA-licensed traders or distributors are given until June 30, 2024 to secure the approval of the said LTO variation; after which selling of medical devices directly to the general public by the said establishments without securing the amended LTO shall be prohibited.

SAUDI ARABIA

Guidance on the development of IVDs for in-house use

The guidance is to support the creation of design and performance data and documents required to support the development of an in-house IVD, the documentations describe in this guidance are required to be submitted to SFDA upon request.

The Guidance defines and clarifies the requirements of manufacturers of point of care (POC) medical devices. In-house in vitro diagnostic (IH-IVD) medical devices are a subset of POC medical devices. This guidance outlines the development and post market activities for In-house in vitro diagnostic (IH-IVD) medical devices.

Guidance for Surgical Sutures

This guidance applies to manufacturers and authorized representatives of surgical sutures with/without needles used for general soft tissue approximation and wound closure/support.

The applicant of the surgical sutures marketing authorization shall submit the necessary documents to prove that the surgical sutures to be marketed complies with the essential principles of safety and performance which specified in the Requirements for Medical Device Marketing Authorization (MDS-REQ 1), including proof of compliance with relevant Standards.

SINGAPORE

GN-15-Revision 11: Guidance on Medical Device Product Registration

The Document describes procedures and general requirements for the submission of an application for a new product registration medical devices.

GL-04-Revision 3: Regulatory Guidelines for Software Medical Devices – A Life Cycle Approach

The document is intended for stakeholders who are involved in software medical device development and /or supplying such devices in Singapore.

The Health Sciences Authority (HSA) is issuing these guidelines to provide clarity on the regulatory requirements for software medical devices in its entire life cycle. The requirements are presented starting from product development, all the way to post- market duties following product introduction in Singapore.

It is important to note that these guidelines reflect HSA’s current thinking and practice, and should not be misconstrued as a new regulatory control on software medical devices.

GN-17 Revision 3: Guidance on Preparation of a Product Registration Submission for GMD using the ASEAN CSDT

The document aims to provide guidance on the preparation of a product registration submission for general medical devices using the ASEAN CSDT. In particular, this document serves to provide a summary of the information to be submitted under each section of the ASEAN CSDT. For detailed technical information to be provided under each section of the dossier.

Product registration applications for medical devices submitted to HSA may be prepared in the format set out in the ASEAN Common Submission Dossier Template (CSDT) or the International Medical Device Regulators Forum (IMDRF) Non-In Vitro Diagnostic Device Market Authorisation Table of Contents (nIVD MA ToC).

GN-17 Revision 3: E-Submission Guide for General Medical Devices for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS

The document is intended to provide guidance on submission of a product registration dossier to HSA via the Medical Device Information and Communication System (MEDICS). This guide specifies the appropriate modules in MEDICS for uploading of the corresponding sections of the CSDT or IMDRF ToC dossier.

Annex 2 for GN-17 and GN18 List of Configurations

List of configurations of medical device to be registered for GN 17 (Guidance on the Common Submission Dossier Template for General Medical Devices) and GN 18 (Guidance on the Common Submission Dossier Template for In Vitro Diagnostic Medical Devices)

GN-18 R3 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT

The document aims to provide guidance on the preparation of a product registration submission for general medical devices using the ASEAN CSDT. In particular, this document serves to provide a summary of the information to be submitted under each section of the ASEAN CSDT.

Product registration applications for medical devices submitted to HSA may be prepared in the format set out in the ASEAN Common Submission Dossier Template (CSDT) or the International Medical Device Regulators Forum (IMDRF) In Vitro Diagnostic Device Market Authorisation Table of Contents (IVD MA ToC).

E-Submission Guide for IVD MD for ASEAN CSDT and IMDRF ToC based Submissions in MEDICS R3

The document is intended to provide guidance on submission of a product registration dossier to HSA via the Medical Device Information and Communication System (MEDICS). This guide specifies the appropriate modules in MEDICS for uploading of the corresponding sections of the CSDT or IMDRF ToC dossier.

TR-01 R3: Contents of a Product Registration Submission for General Medical Devices using the ASEAN CSDT

The document aims to provide guidance on the preparation of a product registration submission for general medical devices using the ASEAN Common Submission Dossier Template (CSDT). In particular, this document serves to clarify the information to be included in each section of the CSDT and the format that this information is to be submitted in.

TR-02: Contents of a Product Registration Submission for In Vitro Diagnostic Medical Devices using the ASEAN CSDT

The document aims to provide guidance on the preparation of a product registration submission for In Vitro Diagnostic (IVD) medical devices using the ASEAN Common Submission Dossier Template (CSDT). In particular, this document serves to clarify the information to be included in each section of the ASEAN CSDT and the format that this information is to be submitted in.

SOUTH KOREA

Notice of promulgation of partial amendment to the Enforcement Rules of the Medical Device Act (Prime Minister Ordinance No. 1946)

The purpose of this rule is to stipulate matters delegated by the Medical Device Act and the Enforcement Decree of the same Act and matters necessary for its implementation. The standards and procedures for classification and designation of medical devices.

Application Procedure for Manufacturing License – A person who wishes to obtain a medical device manufacturing license pursuant to the main text of Article 6 (1) of the Act must submit the following documents (including applications in electronic form) in the attached Form No. 1: (including electronic documents) must be attached and submitted to the Commissioner of the Regional Food and Drug Safety Office having jurisdiction over the location of the manufacturing plant. In this case, if there are two or more manufacturing plants located at different locations, an application may be submitted to the Commissioner of the Regional Food and Drug Safety Office in charge of one of the manufacturing plants.

SPAIN

The AEMPS informs of the update of the instructions for the Invacare NorBed Kid bed for the correct installation and use of the sliding side rail

The Spanish Agency for Medicines and Health Products (AEMPS) has been aware, through the company Invacare Rea AB, Sweden, of several incidents related to the incorrect use and installation of the sliding side rails, due to the imprecision of the User Manual.

NorBed Kid is an electrically operated, height-adjustable pediatric bed with a profiled support surface. It is designed to assist children between 3 and 12 years of age with a disability or limited mobility in both clinical and home environments and is used to mitigate, alleviate and treat certain clinical conditions. These beds have three modalities: they can be used with a fixed railing, with a folding door railing, or with a sliding railing.

U.S. Food and Drug Administration (FDA) issued Update on Artificial Intelligence and Machine Learning in Software as a Medical Device

The paper describes four areas of focus for CBER, CDER, CDRH, and OCP regarding the development and use of AI across the medical product life cycle.

CBER, CDER, CDRH and OCP plan to tailor their regulatory approaches for the use of AI in medical products to protect patients and health care workers and ensure the cybersecurity of medical products in a manner that promotes innovation.

UNITED KINGDOM

Update: Standard on Implementation of the Future Regulations

The government intends to introduce new regulations for medical devices that prioritise patient safety, give patients access to the medical devices they need and ensure the UK remains an attractive market for medical technology innovators.

The guidance has been updated with a Roadmap towards the future regulatory framework for medical devices which sets out intended timescales for delivery of the future core regulations.

The regulations will be delivered through four Statutory Instruments. It is intended that priority measures to enhance post-market surveillance will be put in place first in 2024, with core elements of the new framework expected to be in place in 2025.

Update: Guidance on UK approved bodies for Medical devices

UK approved bodies for Medical devices are listed in below link

https://www.gov.uk/government/publications/medical-devices-uk-approved-bodies/uk-approved-bodies-for-medical-devices

Guidance on Regulation of devices in Northern Ireland

The guidance provides general information about regulatory requirements for placing medical devices and IVD devices on the Northern Ireland market only.

The Medical Devices in Vitro Diagnostic Devices etc. Amendment Regulations 2024 came into force on 21 March 2024 and introduce provisions required for implementing the IVDR in Northern Ireland.

Update: Guidance on Notify the MHRA about a clinical investigation for a medical device

To carry out a clinical investigation as part of the process to obtain a UKCA / CE / CE UKNI marking for your medical device. You must inform the MHRA if we are planning to do this at least 60 days before starting your investigation.