Medical Devices-USA/Europe Regulatory News – August 2023

USA (FDA)

Medical Device User Fee Rates for Fiscal Year 2024

The FD&C Act, as amended by MDUFA V, authorizes FDA to collect user fees for certain medical device submissions and annual fees both for certain periodic reports and for establishments subject to registration.

The US FDA has released its fee schedule for fiscal 2024. Standard PMAs will cost $483,560 next year, while 510(k) fees are set at $21,760.

Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations – Premarket Notification (510(k)) Submissions

This guidance to provide labeling recommendations for hydrogen peroxide-based contact lens care products (HPCPs) submitted in premarket notification (510(k)) submissions. This guidance document applies to all HPCPs. These devices are classified under 21 CFR 886.5918 and 21 CFR 886.5928 with the product codes listed in the document.

These labeling recommendations are important because misuse associated with these devices has resulted in serious eye injuries. FDA believes that the labeling recommendations in this guidance may help manufacturers develop labeling with information about specific risks and directions for use of the HPCPs in conjunction with a user’s prescribed contact lenses. These labeling recommendations are intended to promote the safe and effective use of HPCPs and ensure that consumers receive and understand information regarding the benefits and risks associated with the use of the device.

Qualification of Medical Device Development Tools

The purpose of this guidance is to describe the framework for voluntary proposal and qualification of an MDDT, including definitions of applicable terms, criteria for evaluating an MDDT for a specific context of use, considerations for qualification, and the contents of a qualification package. For purposes of this guidance, a submitter is a person, group, consortium, or organization (including the federal government) that takes responsibility for and initiates the MDDT qualification process using the procedures described in this guidance.

This guidance does not discuss the review of MDDTs (also referred to as “tools” in this guidance) that are submitted in individual premarket regulatory submissions for use with a particular medical device, nor does it address the specific evidentiary or performance expectations for the qualification of an individual MDDT submission.

EUROPE 

Updated document – Notified Bodies Survey on certifications and applications (MDR/IVDR) (Survey results with data status 31 March 2023)

To support monitoring and analyzing the availability of medical devices on the EU market in the context of the implementation of medical devices and in vitro diagnostic medical devices Regulations from the perspectives of key stakeholders.

This document was produced in the frame of the SC 2021 P3 03 under the DG SANTE Framework contract (FWC SANTE/2021/OP/0002) for evaluation, impact assessment, monitoring and other related services in relation to health and food policies.

Rev. 1 – Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607

The amendment of the MDR and of the IVDR through Regulation (EU) 2023/607 aims to ensure a high level of public health protection, including patient safety and an avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements. For that purpose, manufacturers and notified bodies are given sufficiently more time to carry out, in accordance with the MDR, the conformity assessment of devices covered by a certificate or a declaration of conformity issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC. Moreover, the deletion of the ‘sell off’ date in the MDR and the IVDR aims to prevent unnecessary disposal of safe devices.

The answers to the questions set out below have been developed taking into account the objectives pursued by the amendment with a view to making best use of the additional time provided by the extension of the MDR transitional period.

Updated – Factsheet for authorities in non-EU/EEA states on medical devices and in vitro diagnostic medical devices

The MDR replaced the Medical Devices Directive 93/42/EEC (MDD) and the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD). The MDR became applicable on 26 May 2021.

The IVDR replaced the In Vitro Diagnostic Medical Devices Directive (98/79/EC) (IVDD). The IVDR became applicable on 26 May 2022.

Both Regulations provide for additional transition periods, under certain conditions. The requirements enter into application gradually, starting with the provisions related to the designation of notified bodies and the ability of manufacturers to apply for certificates under the Regulations.

The MDR and the IVDR are directly applicable to all EU Member States and therefore create a level playing field across the EU market. 

New publication of Harmonised standards under the medical devices Regulations

Harmonised standards under the medical devices Regulations are developed by CEN and CENELEC as European standardisation organisations, on the basis of a Standardisation Request issued by the Commission according to Regulation (EU) No 1025/2012EN. Once their references are published by the Commission in the Official Journal of the European Union, the voluntary use of those standards confer presumption of conformity with the requirements of the Regulations they aim to cover.

 

FINLAND (FMEA)

Extension of the transition periods for requirements for products such as medical devices

Annex XVI of the Medical Devices Regulation defines products that do not have a medical purpose, but which are similar in function and risk profile to medical devices. This product group includes, for example, fillers used in the beauty care industry and light impulse devices for hair removal. The validity of the transitional regulations for these products has been extended by the implementing regulation published in June.

The regulation has been applied since June 22, 2023. The validity of the transitional provisions will be extended until December 31, 2028 or December 31, 2029. The length of the transition period depends on whether the product is undergoing a clinical trial or not. Transition periods only apply to products whose conformity assessment requires the participation of a notified body. From the date of application of the regulation, the notified body can issue a certificate in accordance with the MD regulation for the products of Annex XVI.

Open funding applications for medical devices in the EU4Health program

The European Commission has opened two application programs related to medical devices as part of the EU4 Health Program (EU4H) funding application. The application was opened on 15 June 2023 and will be open until 17 October 2023.

The objective of the call EU4H-2023-PJ-11 — Call for proposals for a program on Orphan medical devices, in particular targeting Pediatric patients (HS-g-23-65) is to support organizations and consortia that help universities, scientific communities and equipment developers in the development of rarely needed equipment. With the help of the call, the aim is to develop support for innovations in the devices of a small target group.

 

GREECE (EOF-NMA)

Notice regarding the transitional provisions of Reg. (EU) 2017/745 on Medical Devices (M/D)

The amendment of the MDR and of the IVDR through Regulation (EU) 2023/607 aims to ensure a high level of public health protection, including patient safety and an avoidance of shortages of medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements. For that purpose, manufacturers and notified bodies are given sufficiently more time to carry out, in accordance with the MDR, the conformity assessment of devices covered by a certificate or a declaration of conformity issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC. Moreover, the deletion of the ‘sell off’ date in the MDR and the IVDR aims to prevent unnecessary disposal of safe devices.

 

ITALY (MOH)

Obligations of registration and storage of the unique device identifier (UDI) by healthcare institutions and healthcare professionals

The decrees provide for the obligation to register and store the UDI, in electronic form, for health institutions and for health professionals who do not exercise their professional activity in the context of a health institution.

For medical devices in particular, the decree:

• Reiterates the obligation already established in Regulation (EU) 2017/745 for all class III implantable medical devices that institutions and healthcare professionals have supplied and received
• Introduces the same requirement for all class III and class IIb implantable medical devices

The decrees also indicate the possibility of registering and storing UDIs for all medical devices and in vitro diagnostic medical devices, including those belonging to other risk classes, on a voluntary basis.

SWITZERLAND (SWISS MEDIC)

Requirements for the maintenance of sterile containers (sterilization containers according to SN EN 868-8)

The aim of this leaflet is to specify the requirements for the maintenance of sterile containers according to SN EN 868-8 in order to ensure that maintenance is carried out periodically according to the manufacturer’s instructions and taking into account the risks inherent in the product, and that product and patient safety is guaranteed accordingly.

During AEMP inspections in hospitals, Swissmedic repeatedly finds that sterile containers are not maintained in accordance with regulations and that non-functional sterile containers continue to be used.

Reusable sterile containers (sterilization containers) according to the standard SN EN 868-8 “Packaging for medical devices to be sterilized in the final packaging – Part 8: Reusable sterilization containers for steam sterilizers according to EN 285 – Requirements and test methods” are final packaging for medical devices to be steam sterilized, used invasively. 

 

UNITED KINGDOM (MHRA)

Implementation of medical devices future regime

MHRA is aiming for core aspects of the future regime for medical devices to apply from 1 July 2025. On 26 June 2022, the MHRA published the government response to the public consultation on the future regulation of medical devices in the United Kingdom. The response outlined the intended regulatory reform including the transitional arrangements for CE and UKCA marked devices placed on the Great Britain market. This page provides an update on the timelines to implement the future Medical Device Regulations.

The approach to this reform was outlined in the government response to the 2021 consultation on the future regulation of medical devices in the UK. The government will ensure that there is a proportionate, phased approach to the implementation of the future regulatory framework, which supports system readiness and minimizes the risk of supply disruption for UK patients. This guidance has been updated to reflect that the government is now aiming for core aspects of the future regime for medical devices to apply from 1 July 2025.

Update: Updated guidance to reflect that the World Trade Organization (WTO) has published the draft Post Market Surveillance Requirements Statutory Instrument. 

Software and Artificial Intelligence (AI) as a Medical Device

Information for manufacturers, healthcare organizations and professionals, researchers, and patients & public on Software as a Medical Device (SaMD), including Artificial Intelligence as a Medical Device (AIaMD).

Software (including AI) plays an essential part in health and social care. In the UK, many of these products are regulated as medical devices (or as in vitro diagnostic medical devices (IVDs). This guidance provides access to important Software Group outputs that might be of assistance.

Update: The report that was added to the Artificial Intelligence section has been temporarily removed for necessary corrections.

Regulating medical devices in the UK

The guidance explains about what you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets. The Medicines and Healthcare Products Regulatory Agency (MHRA) is responsible for regulating the UK medical devices market.

This guidance provides information on the UK system, including for:

• Getting your device certified
• Conformity marking your device
• Registering your device with the MHRA

This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland. Under the Northern Ireland Protocol, different rules apply in Northern Ireland to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, please see Regulation of medical devices in Northern Ireland below.

This guidance only applies to medical devices and does not cover other CE or UKCA marked products, which are subject to separate guidance. This information is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations. Speak to your solicitor or trade association if you are unsure which regulatory framework applies to your goods. As expanded on in the implementation update on work towards a strengthened future medical devices regime, the government has put in place legislation to extend acceptance of CE marked devices in Great Britain beyond 30 June 2023. 

Register medical devices to place on the market

Guidance for how to register your medical devices with the Medicines and Healthcare Products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland.

The following requirements apply to place your device on the UK market.

Placing a device on the Great Britain market

It is a requirement of the UK MDR 2002 that you inform the MHRA before you place your device on the market in Great Britain.

You must register if you or your company sells, leases, lends or gifts:

• Class I, IIa, IIb or III devices you have manufactured
• Class I, IIa, IIb or III devices you have refurbished or re-labelled with your own name
• Any system or procedure pack containing at least one medical device
• Custom-made devices
• IVDs you have manufactured
• IVDs undergoing performance evaluation

Update: Updated guidance and template for extended CE certificate validity under EU MDR Article.

Borderlines with medical devices and other products in Great Britain

This document gives help in working out if your product is considered to be a medical device under UK legislation. 

This guidance document only covers borderline products with general medical devices as specified in Part II of the Medical Device Regulations 2002 (as amended), and therefore does not cover borderlines with in-vitro diagnostic medical devices or active implantable medical devices. The advice given in this document is by nature general and if manufacturers are uncertain, they should seek further advice from the MHRA after consulting the other guidance documents. Products falling outside the scope of the regulations for medical devices may still be covered by other parts of the Consumer Protection Act or other UK legislation and must be safe for their intended purpose. 

Update: File ‘updated in light of the extension of acceptance of CE marked devices on the GB market’ updated in light of the extension of acceptance of CE marked devices on the GB market. 

Approved bodies for medical devices

Guidance on what approved bodies are, what they do and how you can become one. 

The Medicines and Healthcare Products Regulatory Agency (MHRA) is the designating and competent authority in the UK.

An approved body is an organization that has been designated by the MHRA to assess whether manufacturers and their medical devices meet the requirements set out in the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).

Manufacturers can apply to any UK approved body and once they have the necessary certification their products can be sold anywhere in Great Britain (England, Wales and Scotland). Following an appropriate assessment, the approved body will issue relevant certification allowing manufacturers to place UKCA marking on their products and place them on the market in Great Britain.

Update: This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023. 

Medical devices regulations: compliance and enforcement

MHRA has the responsibility to check that medical devices in the UK comply with legal requirements.

This guidance includes:

• Contact details to report a non-compliant medical device
• Information on MHRA’s enforcement duties after receiving a complaint

MHRA’s routine monitoring role

MHRA is the designated authority that administers and enforces the law on medical devices in the UK. It has a range of investigatory and enforcement powers to ensure their safety and quality. The government has extended acceptance of CE marked medical devices in Great Britain. For more detail on this see the implementation update on work towards a strengthened future medical devices regime.

Update: This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023. 

Medical devices: software applications (apps)

Information on when software applications are considered to be a medical device and how they are regulated.

Application of this Guidance this guidance is applicable to standalone software and apps placed on the Great Britain market. Great Britain is England, Wales and Scotland. The UKCA (UK Conformity Assessed) mark is used for certain goods, including medical devices, being placed on the Great Britain market. This guidance gives examples of software and apps which meet the definition of a medical device and it outlines requirements for UKCA marking of medical devices.

Update: Updated file ‘Medical device stand-alone software including apps (including IVDMDs)’ to reflect that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.

Medical devices: off-label use

It’s considered off-label use if you use a medical device differently to how the manufacturer has instructed. This includes changing a medical device to suit new needs.

This guidance is only relevant for medical devices on Great Britain (England, Wales and Scotland). Please note that CE-marked medical devices continue to be accepted on the Great Britain market with the deadline for acceptance depending on the type of device and the legislation it complies with. The latest of these deadlines is 30 June 2030. The government has extended acceptance of CE marked devices in Great Britain. For more detail on this see the implementation update on work towards a strengthened future medical devices regime. You should use medical devices as described by the manufacturer in the instructions. If you use the device in any other way, it’s considered ‘off-label’ use. Without the manufacturer’s approval this will be at your own risk and you or your employer could become liable for civil claims for damages from injured patients or their families if something goes wrong with the device. Health and safety related legislation is also applicable to employers providing any equipment including devices for use in the workplace that the health and safety executive provide advice and guidance upon.

Off-label use of a device could lead to dangers including:

• Adverse reactions
• Inadequate sterilization
• Insufficient mechanical strength and/or structural integrity
• Insufficient durability
• Misuse due to lack of adequate training for the device

Update: This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.

Guidance on Class I medical devices

Advice for manufacturers of Class I medical devices for placing products on the UK market

This guidance applies to manufacturers of Class I medical devices, including accessories but excluding devices intended for clinical investigation and custom-made devices. This guidance is divided into sections on the different rules that apply in Great Britain (England, Wales and Scotland) and Northern Ireland. For Northern Ireland, different rules apply to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, please see the section on Class I devices in Northern Ireland below.

CE marked medical devices continue to be accepted on the Great Britain market with the deadline for acceptance depending on the type of device and the legislation it complies with. The latest of these deadlines is 30 June 2030.You will be able to self-certify your Class I medical device for the CE mark, and place your device on the Great Britain market. You will not require an Authorized Representative if you are solely placing your Class I device on the Great Britain market. If you are self-certifying your Class I medical device for the CE mark, you will need to meet the requirements of the Medical Devices Regulation (2017/745) from 26 May 2021. See our guidance for more information on the use of the CE mark for Great Britain.

The government has extended acceptance of CE marked medical devices in Great Britain. For more detail on this see the implementation update on work towards a strengthened future medical devices regime.

Update: This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.

Virtual manufacturing of medical devices

Guidance for manufacturers who don’t design or manufacture devices but place their names on the product. 

All virtual manufacturers must now hold the full technical documentation for any product they place on the market under their name. All manufacturers are expected to hold full technical documentation in order to demonstrate that the medical device that they place on the market, under their own name, meets the regulatory requirements.

The technical documentation should be fully integrated into the manufacturer’s quality management system where applicable and should contain data relevant to the manufacturer (e.g. labels, instructions for use, risk assessment etc.). Where the virtual manufacturer does not hold the rights related to product design, the UK Approved Body/EU Notified Body and the MHRA may accept a technical file from the virtual manufacturer that has redacted proprietary information as long as the redacted information is not essential for the purposes of the UK Approved Body/EU Notified Body or the MHRA assessing whether the medical device complies with the regulatory requirements. Redactions should be as limited as possible. 

Update: This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.

Medical devices: legal requirements for specific medical products

Guidance for manufacturers on the regulations that apply to prosthetic, orthotic and ophthalmic devices. 

Read this for information on how to comply with the legal requirements for prosthetic, orthotic and ophthalmic devices. The guidance includes:

• Classification
• Custom-made prosthetic, orthotic and ophthalmic devices
• Examples

This guidance is specific to medical devices placed on the market in Great Britain. For guidance on the legislation applicable to medical devices in Northern Ireland, please see our published guidance.

The government has extended acceptance of CE marked medical devices in Great Britain. For more detail on this see the implementation update on work towards a strengthened future medical devices regime

Update: This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.

Timeframe for accepting CE marked medical devices in Great Britain extended

CE marked medical devices will continue to be accepted on the Great Britain market beyond 30 June 2023.

The Government has made regulations (The Medical Devices (Amendment) (Great Britain) Regulations 2023) that enable CE marked medical devices to be accepted in Great Britain for defined periods beyond 30 June 2023.This measure aims to support the ongoing and safe supply of medical devices within Great Britain and facilitate a smooth transition towards a future strengthened regulatory framework for medical devices.

It is the first statutory instrument in a series that are planned to implement the strengthened framework. Next in the series, the MHRA intends to lay a statutory instrument later this year that will put in place enhanced post-market surveillance requirements. 

DEHP phthalates in medical devices

Information for manufacturers and users of medical devices containing plastic with DEHP phthalates.

The government has extended acceptance of CE marked medical devices in Great Britain. For more detail on this see the implementation update on work towards a strengthened future medical devices regime.

Update: This guidance has been updated now that the Government has made regulations that enable CE marked medical devices to continue to be accepted in Great Britain for defined periods beyond 30 June 2023.