Medical Devices-USA/Europe Regulatory News-October 2023

USA

Electronic Submission Template for Medical Device 510(k) Submissions

The FDA Electronic submission template for medical device guidance describes the technical standards associated with preparation of the electronic submission template for 510(k)s that enable submission of the 510(k) electronic submission solely in electronic format. The electronic submission template includes the information and guided prompts FDA believes will best facilitate the collection and assembly of the necessary elements of a ‘complete’ submission, as required by regulation or essential to FDA’s substantive review of the 510(k) submission. This guidance is not intended to specify the user-interface and detailed content of the eSTAR, but instead is limited to establishing the 510(k) electronic format and standards for complying with the FD&C Act. FDA intends to implement new versions of eSTAR as relevant policies change. FDA also has an ongoing process to collect and consider public comments and stakeholder feedback, which is described on FDA’s website.

Antimicrobial Susceptibility Test (AST) System Devices – Updating Breakpoints in Device Labeling

The AST guidance is intended to provide industry and FDA staff with information regarding updating susceptibility test interpretive criteria (STIC)/breakpoints and associated performance data in device labeling for antimicrobial susceptibility test (AST) system devices in response to breakpoint changes posted on the FDA-Recognized Antimicrobial Susceptibility Test Interpretive Criteria website (STIC Website). This guidance is expected to facilitate the timely adoption of updated breakpoints in AST system devices, which helps to ensure device safety and effectiveness.

The scope of this guidance is limited to devices classified under 21 CFR 866.1640, 21 CFR 866.1645, or 21 CFR 866.1650 and does not include antimicrobial susceptibility test discs classified under 21 CFR 866.1620.12 The scope of this guidance is also limited to recommendations and marketing submission content expectations for PCCPs that include planned modifications to update AST system device labeling to include the updated breakpoints. This guidance does not describe recommendations for other planned modifications to AST system devices, including other planned modifications to update AST system device labeling unrelated to updating breakpoints. It is possible that other modifications could significantly affect the safety or effectiveness of the device and may require a new 510(k).

Technical Considerations for Medical Devices with Physiologic Closed-Loop Control Technology

This document highlights technical considerations for the development of medical devices employing PCLC technology to ensure safe and effective use and provides recommendations for the content of premarket submissions (i.e., premarket notifications (510(k)s), De Novo requests, premarket approval applications (PMAs), Humanitarian Device Exemptions (HDEs)) for such devices.

This guidance provides technical considerations related to the PCLC technology when designing PCLC medical devices. PCLC medical devices can include functions or components that have risks separate from the PCLC functions that are not addressed in this guidance. Not all considerations in this guidance will be applicable to every PCLC device given the variety of device types that can incorporate PCLC technology. Manufacturers should determine and justify in premarket submissions which considerations are appropriate for their device based on the technology being used and the intended use of the device.

Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

This guidance document is applicable to devices with cybersecurity considerations, including but not limited to devices that have a device software function or that contain software (including firmware) or programmable logic. The guidance is not limited to devices that are network-enabled or contain other connected capabilities. This guidance describes recommendations regarding the cybersecurity information to be submitted for devices under the following premarket submission types, when submitted to the Center for Devices and Radiological Health (CDRH) or the Center for Biologics Evaluation and Research (CBER):

• Premarket Notification (510(k)) submissions
• De Novo requests;
• Premarket Approval Applications (PMAs) and PMA supplements;
• Product Development Protocols (PDPs);
• Investigational Device Exemption (IDE) submissions;
• Humanitarian Device Exemption (HDE) submissions;
• Biologics License Application (BLA) submissions; and
• Investigational New Drug (IND) submissions.

Fostering Medical Device Improvement: FDA Activities and Engagement with the Voluntary Improvement Program

The FDA’s Center for Devices and Radiological Health (CDRH) is issuing this guidance to describe its policy regarding participation in the Voluntary Improvement Program (VIP). The VIP is a voluntary program facilitated through the Medical Device Innovation Consortium (MDIC) that evaluates the capability and performance of a medical device manufacturer’s practices using third-party appraisals, and is intended to guide improvement to enhance the quality of devices. The VIP builds on the framework piloted through FDA’s 2018 Case for Quality Voluntary Medical Device Manufacturing and Product Quality Pilot Program (CfQ Pilot Program) and incorporates some of the successes and learnings from the pilot. 2 The VIP is only available to eligible manufacturers of medical devices regulated by CDRH and whose marketing applications are reviewed under the applicable provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (including under sections 510(k), 513, 515, and 520).

The VIP is a third-party quality maturity appraisal and continuous improvement program facilitated through the MDIC, which was developed to improve medical device design, production, and quality. The VIP is a voluntary program, not a regulatory requirement. The VIP evaluates a participating manufacturer’s capability and performance in key business processes by having qualified, third-party appraisers discuss, observe, and review the participant firm’s practices. The appraisers evaluate the firm’s practices for the business processes established in the appraisal scope against the integrated best practices within the CMMI model. Then, based on the third-party appraiser’s evaluation of a participant’s practices, the VIP identifies the firm’s strengths and potential opportunities for improvement. The VIP allows the third-party appraiser to share some of that information with FDA. For example, the Agency receives high-level appraisal scores for each assessed practice area, by firm name and location, as well as deidentified, aggregate information from the program.

Use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process

The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993-1, “Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process” to support applications to FDA. This guidance document also incorporates several considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, and recommendations.

The scope of this document and accompanying attachments is limited to the biological evaluation of sterile and non-sterile medical devices that come into direct or indirect contact with the human body. This document specifically covers the use of ISO 10993-1 but also is relevant to other biocompatibility standards (e.g., other parts of the ISO 10993 series of standards, ASTM, ICH, OECD, USP).

Application of Human Factors Engineering Principles for Combination Products: Questions and Answers

This document contains questions and answers for industry and FDA staff on the application of human factors engineering (HFE) principles to the development of combination products as defined under 21 CFR part 3.1 This guidance finalizes the February 2016 draft version entitled Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development. This guidance provides information in a question and answer format and clarifies how the unique aspects of a combination product influence the considerations within the HFE process.

This guidance focuses on considerations for the application of HFE principles to combination products comprised of a medical device4 combined with a drug or a biological product submitted for review in CBER, CDRH, or CDER. This guidance discusses, among other things, the definition of a combination product critical task, considerations for combination products due to the use of drug and device constituent parts6 together, training as part of the user interface, and human factors (HF) validation data to support the combination product user interface that may be included in a premarket submission.

CANADA

Health Canada releases draft guidance on Consultation for determining medical device application type

Health Canada wants feedback on the draft Guidance for determining medical device application type. This guidance: explains the different application types will help manufacturers determine whether certain medical devices, including components and parts, should be combined and submitted as  device licence or authorization application.

Updates to the guidance on medical device establishment licensing (GUI-0016)

On September 6, 2023, Health Canada’s Regulatory Operations and Enforcement Branch revised the guidance on regulatory requirements in relation to the medical device establishment licence (MDEL). incorporated the applicable sections of paragraphs 45 (h) and 45 (h.1) in the amended Medical Device Regulations (MDR) introduced sections 62.21 to 62.26 aligned an MDEL requirement with the MDR clarified various sections of the document including submitting MDEL amendments.

This guidance document covers licensing requirements for MDELs, including who requires an MDEL. It describes how to:

• Apply for an MDEL
• Submit an annual license review before April 1 of each year
• Make change(s) to your existing license (for example, an amendment or section 48 notification)
• Cancel your MDEL
• Reinstate your license after a suspension

EUROPE

Manual on borderline and classification for medical devices under Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices

The Scope of this guideline is Determining whether a given product falls under the definition of a medical device and the application of the classification rules fall within the competence of the authorities of the Member States where the product is on the market. However, when different interpretations of EU legislation occur, public health may be put at risk and the internal market distorted. As both are matters of concern to the Member States and the Commission, it essential to facilitate a dialogue among regulators. Appropriate participation of various stakeholders should also be ensured.

The guidance Manual, records the agreements reached by the Member State members of the Borderline and Classification Working Group (BCWG) following the exchanges under the Helsinki Procedure under Regulation (EU) 2017/745 on medical devices (the MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR). The purpose and operation of the Helsinki procedure is described in the dedicated document here. The BCWG is chaired by the European Commission and consists of representatives of competent authorities from all Member States with a number of stakeholder associations as observers.

Q&A on transitional provisions for products without an intended medical purpose covered by annex XVI of the MDR

This Q&A document intends to facilitate the application of the transitional provisions set out in Commission Implementing Regulation (EU) 2022/23461, as amended by Commission Implementing Regulation (EU) 2023/11942. 

Transitional provisions set out in the MDR have been extended by Regulation (EU) 2023/6074 that also sets out conditions for benefitting from those extended transitional periods. The amended transitional provisions apply from 20 March 2023.

Considering that transitional provisions for products covered by a certificate issued by a notified body in accordance with Council Directive 93/42/EEC (MDD)5 are set out both in the amended MDR and in the CS, Commission Implementing Regulation (EU) 2023/1194 has been adopted to align the transitional provisions set out in the CS to those set out in the amended MDR. The content of this document has been drafted considering the requirements applicable from the amended MDR and the amended CS.

ITALY

MOH Released online service for Customized medical devices, new methods for registering manufacturers

From 25 September Ministry of Health Italy implemented the online service for the registration of manufacturers who make tailor-made medical devices available on the national territory will become operational.

The online service accessible via the impresainungiorno.gov.it portal in the section dedicated to the Ministry of Health will allow the registration of manufacturers and the communication of the list of types of customized medical devices, allowing you to directly obtain a registration number in the list of manufacturers who make customized devices available on the national territory.

The access methods for foreign companies are being defined and will be communicated via notice on the Ministry of Health portal.

Custom-made medical devices, registration of manufacturers

The Decree of the Minister of Health of 9 June 2023 has been published in the Official Journal which identifies the methods for providing information regarding the manufacturer’s identification data and the list of types of customized medical devices made available on the national territory, pursuant to the Regulation (EU) 2017/745.

The decree provides that the registration of manufacturers of customized medical devices in the list of the Ministry of Health takes place exclusively online.

The methods of communication of information are established, referred to in article 7 of the legislative decree of 5 August 2022, n. 137, relating to the manufacturer’s identification data and the list of types of customized medical devices that manufacturers make available on the national territory. The decree also establishes the retention times of the manufacturer’s personal data.

The decree provides transitional provisions for the online registration of manufacturers already registered in the existing lists of the Ministry of Health.

SLOVAKIA

Notice for manufacturers, authorized representatives, importers or distributors of medical devices or in vitro diagnostic medical devices

The State Institute for Drug Control (SUKL) warns manufacturers, authorized representatives, importers or distributors of medical devices or in vitro diagnostic medical devices that:

In accordance with 110b par. 2 of Act No. 362/2011 Coll. on Medicines and Medical Devices and on Amendments to Certain Acts, a manufacturer, authorized representative, importer or distributor who makes a medical device or in vitro diagnostic medical device available on the market in the Slovak Republic according to special regulations, 72a) is in in electronic or paper form, obliged to notify this fact to the state institution within 14 days of the first access medical device or in vitro diagnostic medical device on the market in the Slovak Republic by submitting the information and documentation necessary to demonstrate the conformity of the medical device or in vitro diagnostic medical device, which are a standardized form, EU declaration of conformity, conformity assessment certificate, outer packaging and manual; this obligation does not apply to making available a class I medical device and a class A in vitro diagnostic medical device, if the state institute does not request them to notify and send these documents.

Obligation for the manufacturer, authorized representative, importer or distributor to notify the State Institute for Drug Control of the information and documentation necessary to prove the conformity of the medical device or in vitro diagnostic medical device for making the medical device or in vitro diagnostic medical device available on the market in the Slovak Republic.

SWITZERLAND

Revision of MedDO and IvDO – Swissmedic released New requirements for product groups without an intended medical purpose and alignment with Regulation (EU) 2023/607 on medical devices and in vitro diagnostic medical devices.

Amendments of the EU-MDR 2017/745 regarding transitional periods for certificates, and of the EU-MDR and EU-IVDR 2017/746 regarding the elimination of deadlines for putting into service and placing on the market, were published in the EU on 20 March 2023. Swissmedic published a communication on enforcement in March 2023 (MDR/IVDR amendment: Equivalence with EU Regulation on Medical Devices ensured). The provisions have now been transposed into the ordinances in Switzerland and approved by the Federal Council.

The Implementing Regulations (2022/2346/47) tighten the requirements for product groups without an intended medical purpose that are comparable with medical devices in terms of their function and risk profile. These products fall under the scope of the MedDO (Art. 1 para. 1 let. a). They are mainly used in cosmetics, cosmetic surgery, bodyforming and in isolated instances also in interventional psychiatry and by opticians.

UNITED KINGDOM

Notify the MHRA about a clinical investigation for a medical device

The guidance explains about How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.

A notification to the MHRA will not be required for medical devices that are UKCA / CE / CE UKNI marked for the purpose that is under investigation.

Update

Updated to include Medical devices: clinical investigations and performance studies in Northern Ireland replacing Temporary Disapplication of Sponsors and Legal Representatives in Northern Ireland.

Medical devices: EU regulations for MDR and IVDR (Northern Ireland)

The guidance explains about Information about the new EU Regulations for medical devices (MDR) and in vitro diagnostic medical devices (IVDR), and their implementation in Northern Ireland.

Update

Updated to include Medical devices: Clinical investigations and performance studies in Northern Ireland replacing Temporary Disapplication of Sponsors and Legal Representatives in Northern Ireland.

The Innovative Devices Access Pathway (IDAP) (Published on 19 September, 2023)

The Innovative Devices Access Pathway (IDAP) pilot is an initiative to bring new technologies and solutions to the National Health Service (NHS) to help with medical needs that are not currently being met.

The aim of IDAP is to enable and improve patient access to innovative and transformative medical devices by providing an integrated and enhanced regulatory and access pathway to developers. The aim of the pilot is to test the main elements of the pathway and to provide informative learning and feedback that helps to build the future IDAP.

The IDAP is open to UK and international commercial and non-commercial developers with new health technology solutions. Successful applicants will receive support at key stages of their product design and development process from the IDAP partners.

https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap

Guidance link

https://www.gov.uk/government/publications/the-innovative-devices-access-pathway-idap/the-innovative-devices-access-pathway-idap-pilot-phase

MHRA phase I accreditation scheme

How to join the phase I accreditation scheme?

The MHRA phase I accreditation scheme is a voluntary scheme for organizations conducting phase I trials, in particular for those conducting first in human (FIH) trials.

The scheme aims to make sure trials are as safe as possible and to create public confidence in the regulation of phase I clinical trials.

Organizations in the scheme have to exceed the basic regulatory good clinical practice (GCP) standards by having additional procedures that include the highest standards for avoiding harm to trial subjects and for handling any medical emergencies.

Update

Replaced List of Accredited Units July 2023 with updated version: List of Accredited Units_15 September 2023

IRELAND

HPRA Statement in relation to CHI at Temple Street

Medical devices must meet the requirements of EU regulations and bear a CE mark in order to be legally supplied to the market in Ireland. Certain medical devices, such as those implanted in patients, must be assessed by a conformity assessment body in Europe, known as a Notified Body (NB), before they can be legally supplied. The NB assesses if a device meets the EU regulations. If a device conforms, the NB issues a CE certificate to the manufacturer (see list of Notified Bodies) This allows the manufacturer to place the product on the market. Within the European medical devices legislative framework, the HPRA does not approve or certify medical devices for sale in Ireland or any other EU member state.

The HPRA’s role is in relation to monitoring the safety of CE marked medical devices is activated once a medical device is placed and becomes available on the Irish market.

The HPRA understands at this point the ‘compression springs’ referred to in relation to orthopedic surgery at CHI at Temple Street were not intended to be sold or supplied as medical devices.