USA
FDA Data Standards Catalog Version 10.3
The FDA has released Version 10.3 of the Data Standards Catalog. This catalog identifies the data standards that should be used for regulatory submissions and related documentation. It outlines the standards applicable to various submission types and associated technical documentation submitted to the FDA.
EUROPE
MDCG 2024-5 – guidance on content of the Investigator’s Brochure for clinical investigations of medical devices
The Investigator’s Brochure (IB) must include relevant clinical and non-clinical information about the investigational device that is available at the time of the clinical investigation application. The information should be presented clearly and objectively in a concise, balanced, and non-promotional manner. This enables investigators and site teams to understand the device and conduct their own unbiased assessment of the potential benefits and risks of exposing study participants to the investigational device. The IB should also provide sufficient details to ensure the safe and proper use of the device during the investigation.
This guidance aims to assist sponsors in preparing the Investigator’s Brochure by explaining the type of information expected in each section. The objective is to reduce queries from competent authorities during the evaluation of clinical investigation applications. The document is based on requirements from both the Medical Device Regulation (MDR) and ISO 14155:2020, as well as regulatory experience from competent authorities.
MDCG 2022-9 / Rev.1 – Summary of safety and performance Template
Under Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), manufacturers must prepare a Summary of Safety and Performance (SSP) for Class C and Class D IVD devices, except those used solely for performance studies. The SSP must be validated by a Notified Body and made publicly available through the European database on medical devices (EUDAMED).
The SSP should contain information intended for the device’s users and, where applicable, for patients. The document must be maintained and updated within EUDAMED. For devices intended for professional use, the SSP should target healthcare professionals. If the device is intended for self-testing, the information should be written in language that is easily understood by patients or lay users, taking into account the characteristics of the intended population.
MDCG 2024-4 – Safety Reporting in Performance Studies of IVDs
Safety reporting requirements for performance studies involving in vitro diagnostic medical devices must comply with Article 76(2) of Regulation (EU) 2017/746 (IVDR). Sponsors are required to promptly report specific safety events to all Member States where the performance study is being conducted through the electronic system referenced in Article 69 of the IVDR.
For post-market performance follow-up (PMPF) studies involving CE-marked devices used within their intended purpose, the reporting requirements outlined in Articles 76(5–6) apply. In these cases, vigilance provisions described in Articles 82 to 85 of the IVDR and related implementing acts also apply.
Study on Reprocessing and Reuse of Single-Use Devices in the EU
The European Commission’s Directorate-General for Health and Food Safety (DG SANTE), through the European Health and Digital Executive Agency (HaDEA), commissioned a study evaluating the implementation of Article 17 of Regulation (EU) 2017/745 regarding the reprocessing of single-use medical devices.
The study began in December 2022 and lasted approximately 14 months. It was carried out by a consortium led by the Austrian National Public Health Institute (Gesundheit Österreich GmbH/GÖG) with partners including Civic Consulting, S&P Global, and Areté. The objective was to assess how the MDR provisions related to reprocessing single-use devices are being applied across European countries.
FINLAND
EU Parliament Approval of Amendments to MD and IVD Regulations
The European Parliament approved amendments introducing new requirements for manufacturers to notify authorities in advance if interruptions in device availability or discontinuation of production are expected to significantly affect healthcare services.
The amendments also address extended transitional periods under the IVD Regulation. These extensions provide additional time for manufacturers to comply with the IVDR, with the transition timelines varying depending on device type and risk classification.
Reminder on Transition Period Extension for Medical Device Manufacturers
The Medical Device Regulation (EU) 2017/745 allows manufacturers to continue producing devices under previous directives for a limited period, provided certain conditions are met. Finland’s regulatory authority, Fimea, reminds manufacturers that applications to notified bodies must be submitted no later than 26 May 2024. If this deadline is missed, manufacturers will no longer be eligible for the extended transition period and must cease production until MDR compliance is demonstrated.
GERMANY
Requests for Product Classification or Delimitation
Manufacturers or other authorized stakeholders may request a classification or delimitation decision from the Federal Institute for Drugs and Medical Devices (BfArM). Such requests must be submitted informally under Section 6(2) of the Medical Devices Law Implementation Act (MPDG). Applicants may include notified bodies, manufacturers, authorized representatives, or responsible state authorities.
Product delimitation is based on the definition of a medical device provided in Article 2(1) of the MDR, while device classification follows the classification rules outlined in Annex VIII of the MDR.
Incident Reporting by Manufacturers and Authorized Representatives
Until the European database EUDAMED becomes fully operational under Article 33 of the MDR, manufacturers and authorized representatives must continue using the designated reporting forms for incident reporting.
Serious incidents related to medical devices must be reported according to Article 87 of the MDR. For in vitro diagnostic devices, incident reporting must follow Article 82 of Regulation (EU) 2017/746 (IVDR).
HUNGARY
Transition of Clinical Trials from the Clinical Trials Directive to the Clinical Trials Regulation
Sponsors conducting clinical trials under the Clinical Trials Directive (CTD) must transition ongoing studies to the Clinical Trials Regulation (CTR) framework if those studies are expected to continue beyond 30 January 2025. From 31 January 2025 onward, the CTR will apply to all ongoing clinical trials.
PORTUGAL
Implementation of Decree-Law No. 29/2024 for Medical Devices
Portugal has published Decree-Law No. 29/2024 to implement Regulation (EU) 2017/745
within its national legal framework. The legislation establishes rules governing economic operators, healthcare institutions that manufacture and use devices internally, and requirements related to device traceability and use.
The decree also addresses the designation and supervision of notified bodies, as well as market surveillance and inspection activities. Additionally, it sets requirements for the reprocessing and reuse of single-use devices within Portugal, ensuring that safety and performance standards are maintained.
SPAIN
Participation in European Joint Action JAMS 2.0
The Spanish Agency for Medicines and Health Products (AEMPS) is participating in the JAMS 2.0 joint action under the EU4Health program. The initiative aims to strengthen coordination among European authorities in monitoring and controlling the market for medical devices and in vitro diagnostic devices.
AEMPS is involved in four of the eight work packages and leads Work Package 7, which focuses on developing a unified methodology for European market surveillance campaigns. Joint inspections will be conducted by teams consisting of inspectors from multiple EU countries along with inspectors from the country where the economic operator is located.
SWITZERLAND
Information Sheet on Medical Device Software
Swissmedic has released an information sheet intended for manufacturers and developers of medical device software, as well as economic operators such as importers, distributors, and authorised representatives involved in the supply chain. The document provides guidance on regulatory considerations for software classified as medical devices.
UNITED KINGDOM
Guidance on Notifying MHRA About a Clinical Investigation
Manufacturers planning to conduct a clinical investigation as part of obtaining UKCA, CE, or CE UKNI marking must notify the Medicines and Healthcare products Regulatory Agency (MHRA) at least 60 days before starting the investigation. Applications must be submitted electronically through the Integrated Research Application System (IRAS).
Notification is not required for investigations involving devices that already hold UKCA, CE, or CE UKNI marking for the intended purpose being studied.
Updated Guidance on Borderline Products
Updated guidance clarifies how to determine whether a product qualifies as a medical device under the UK Medical Devices Regulations 2002 (as amended). The guidance focuses on borderline cases involving general medical devices and does not address borderline determinations for in vitro diagnostic devices or active implantable medical devices. The document primarily applies to products subject to UKCA marking requirements.
ASIA
CHINA
Notice on the public solicitation of opinions and suggestions on “Guiding Principles for Registration and Review of Laparoscopic Surgery Systems Part 5: Systems and Software”
This review point applies to multiport laparoscopic surgery systems (referred to as surgical systems). According to the current “Medical Device Classification Catalog”, the classification code of this type of product is 01-07-03, and the management category is Class III.
The key points of this review are general requirements for laparoscopic surgery system products. The registration applicant should determine whether the content is applicable based on the specific characteristics of the product. If it is not applicable, the reasons and corresponding scientific basis must be explained in detail, and based on the product’s Specific characteristics will enrich and refine the content of the registration application materials
HONG KONG
The Medical Device Information System (MDIS) is supporting New Applications for listing Medical Devices and Traders
Hong Kong’s Medical Device Division launched the Medical Device Information System (MDIS) on 2 April 2024. This platform provides a centralized online service allowing industry stakeholders to submit applications for listing medical devices and traders under the Medical Device Administrative Control System (MDACS). It also enables reporting of safety alerts and adverse events associated with medical devices.
https://www.mdd.gov.hk/en/mdacs/mdis/index.html
Application for the Listing of Class II/III/IV General Medical Devices (MD101)
Medical Device Administrative Control System Application for the Listing of Class II/III/IV General Medical Devices
https://www.mdd.gov.hk/filemanager/common/useful-information/Form_MD101e.pdf
Application for the Listing of In Vitro Diagnostic Medical Devices (IVDMD) (MD102)
Medical Device Administrative Control System Application for the Listing of In Vitro Diagnostic Medical Devices (IVDMD)
https://www.mdd.gov.hk/filemanager/common/useful-information/Form_MD102e.pdf
Application for Inclusion on the List of Importers / Distributors (MD-IP+D)
Medical Device Administrative Control System – Application for Inclusion on the List of Importers/ Distributors
https://www.mdd.gov.hk/filemanager/common/useful-information/md_ip_d.pdf
https://www.mdd.gov.hk/filemanager/common/mdacs/GN-01-E.pdf
PHILIPPINES
Reminder on Submission of Financial Disclosure Reports
Under Section 35(b) of Republic Act No. 11223, all FDA-licensed manufacturers, traders, repackers, distributor-importers, and distributor-wholesalers of drugs, medical devices, biological products, vaccines, and medical supplies must record and disclose financial relationships with healthcare professionals and healthcare providers.
The Philippine FDA has established the Online Disclosure Reporting System (ODRS) to allow stakeholders to submit financial disclosure reports electronically in accordance with Department of Health Administrative Order No. 2021-0036.
SAUDI ARABIA
Updated regulations outline the requirements for clearing medicines, pharmaceutical products, medical devices, and food items brought for pilgrim use during Hajj. Applications are now received through the External Hajj Unified System of the Ministry of Hajj, and a dedicated email address (Hajj@sfda.gov.sa) has been established for submissions.
SOUTH KOREA
Announcement of partial revision of the “Enforcement Rules of the In Vitro Diagnostic Medical Devices Act”
South Korea announced a partial revision of the Enforcement Rules for the In Vitro Diagnostic Medical Devices Act. The regulation governs the manufacturing, importation, handling, and management of IVD devices to ensure product safety and quality. The revision aims to strengthen oversight and improve international competitiveness while contributing to public health protection.
SRILANKA
Informed to the Local agent regarding the email confirmation process for the foreign manufacturing site application
The National Medicines Regulatory Authority (NMRA) announced that the previous email confirmation process required for Foreign Manufacturing Site Applications (FMSA) has been discontinued. Importers can now submit FMSA applications without obtaining email confirmation from the Head of the Medical Device Division. This change became effective on 22 April 2024 and also applies to pending confirmations.
This applies for pending email confirmations as well.
THAILAND
FDA reduces time for requesting permission Emphasis on difficulty and ease according to the risks of medical device products
Thailand’s FDA has streamlined the process for minor changes related to medical devices. Requests involving simple modifications—such as updates to manufacturer details or product owner information—can now be processed within 15 business days through the electronic submission system.
FDA recommends checking for sure in 3 ways before using medical device products
The FDA also recommends that consumers verify medical device approval before use by checking the product registration number or photographing the product details. Manufacturers, importers, and sellers of unapproved devices may face penalties of up to two years imprisonment, fines up to 200,000 baht, or both. Consumers can report suspicious products through the FDA hotline or provincial public health offices.
