Health Canada Medical Device Listing

Health Canada Medical Device Listing

Health Canada is the regulator of therapeutic products, including medical devices. Health Canada’s Medical Devices Active Licencing Listing (MDALL) contains a list of products that are already in the Canadian medical device market. It also contains the database for products that were previously licensed. This article discusses the various information available on MDALL.

Read our article on overview of medical device registration in Canada to understand the various license requirements for different classes of medical devices. In brief, there are two types of licenses- Medical device establishment license (MDEL) and medical device license (MDL). MDL, the latter of the two, is for medical devices that fall under the category of device class II, III and IV. Medical Device Establishment License (MDEL) is for Class I devices. The Medical Devices Active Licencing Listing (MDALL) database has the license information of all medical device license or MDL.

The Bureau keeps track of all licenced Class II, III, and IV medical devices for sale in Canada. Class I medical devices do not require a medical device licence and are controlled through Establishment Licensing by the Health Products and Food Branch Inspectorate (Compliance and Enforcement).

There are two types of licenses searches available on MDALL:

  • Search Active Licences and
  • Search Archived Licences

Search Active license opens the Medical Devices Active Licence Search window. In the Search Active Licence window, only products that are currently licenced for sale in Canada will be displayed. This window allows you to search the database using one of six parameters:

  • Company Name,
  • Licence Name,
  • Device Name
  • Company ID
  • Licence Number and
  • Device Identifier

Search Archived license opens the Medical Devices Archive Licence Search box. This section of the system contains data on all items ever licenced by the Medical Devices Bureau, with the query result color-coded. Obsolete products are displayed in red, while currently, active products are in black. This window provides only three search parameters, which are as follows

  • Licence number
  • Device name and
  • Device identifier

Health Canada cautions users to not import or purchase medical devices that are not permitted for sale in Canada.

FAQs

What is the use of a medical device license database?

A database of medical devices or license helps the end user understand the quality of a product. It also ensures that the device that is in use is easily traced to it manufacturer. Countries like US and Canada have a well-established device database for transparency. Countries that do not have this may have the devices documented but the information may not be accessible to public.


Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

Testing Standard Requirements around the World

Testing Standard Requirements around the World

Medical device testing- an overview

Medical device testing is a crucial step in manufacturing a product. This mandatory process ensures that the medical device is safe and effective. Testing of medical devices proves that the product complies with the standards and regulations of a country. Moreover, it also sheds light on any product defects. This article discusses the testing requirements and the applicable standards.

Medical device testing applies to all medical devices, in-vitro diagnostic devices, combinational products, and active implantable devices. Some common testing of medical devices is given below:

  • Electrical safety tests
  • Functional safety tests
  • Performance tests
  • Electromagnetic compatibility (EMC) tests
  • Electromagnetic Interference (EMI) tests
  • Immunity Tests
  • Biocompatibility tests
  • Chemical testing
  • Cybersecurity tests (applicable to SaMDs or software that store data)
  • Storage and Transport
  • Ingress Protection

Medical device testing is crucial as the device intended for patient use must be safe. The tests a medical device must undergo depend on the device’s type. To explain further, medical equipment like a ventilator must undergo an electrical safety test. At the same time, a device such as a cannula requires appropriate biocompatibility tests. Hence, the choice for a practical device test is taken with the help of the medical device’s intended use.

The testing procedure should be logical and must begin with a risk analysis. After identifying the failure mechanisms and hazards associated with a device, testing strategies and processes can be devised to quantify the size of these risks. As a result, the purpose of a test method and procedure is to offer evidence that the hazards connected with a device are insignificant or, at the very least, acceptable when weighed against the benefits received from its use.

Types of medical device testing

Medical device testing is broadly categorized into physical, chemical/biological and cybersecurity testing. Physical testing involves the tests such as electrical testing, MRI safety, functional safety tests and EMC tests.

IEC 60601 series is a widely accepted technical standard for the safety and performance of electrical equipment. EMC/EMI tests ensure that the overall device is compatible with other medical devices and works optimally in the device environment when subjected to interference and immunity. Conformance to this standard provides that medical equipment does not create electromagnetic fields that could impair the operation of other devices in the usual environment.

Chemical or biological testing help achieve device compatibility with the surface of the skin. Medical devices that contact skin must comply with the ISO 10993 series- Biological evaluation of medical devices. For this, the manufacturer must consider the choice of material used compatibility between device materials and the biological tissues, cells, and body fluids. Testing methods like stress, shear testing, and ageing tests are performed so that the final product causes the least quality concerns.

Cybersecurity testing is crucial to medical devices so that risks such as unauthorised access to data and breaches are identified, and their occurrence minimised. A common standard followed for medical device software is IEC 62304 and ISO27001. IEC 62304 standard specifies the life cycle requirements for medical device software, whereas in ISO 27001 focuses on data and information security.

It should be noted that each of the above standards is closely related to the ISO standard for risk management of medical devices (ISO 14971). The risks associated with the medical device should be correctly identified, and appropriate tests should be done, proving that the relevant standards are met. Please read our article on global ISO requirements for a better understanding of the ISO standards. 

Testing requirements around the world

To fully comply with the regulations of each country, one must also align with the testing standards accepted within each country. ISO and IEC standards are accepted across the globe. Compliance with these ensures that the devices can be marketed without any major difficulties. This article discusses the testing standards followed in major medical device markets.

In Europe, close to 80% of electrical and electronic standards follow the various IEC International Standards. Standards for electromedical equipment include IEC 60601 series standards for the requirements for high-frequency surgical instruments, short-wave therapy equipment and so on. The EU from time to time releases the harmonized standards list which are the most acceptable standards for the EU compliance.

In the US, accepts certain ISO standards however there are a list of recognized consensus standards that the FDA accepts for medical devices in the US. These include ANSI, AAMI, ATSM and so on. ANSI standards are applicable to a variety of industries like the ISO whereas AAMI testing standards are specific to medical instruments and ATSM standards are specific for materials used in medical devices.

Canada’s list of Recognized Standards for Medical Devices mentions a combination of ISO and ATSM standards. For electromedical compatibility, it accepts CSA standards.

Australia accepts the list of standards referenced in  Conformity Assessment Standard Orders (CASO) and Medical Device Standard Orders (MDSO). It is not mandatory but conformance to these standards are recommended.

FAQs

Why are testing standards important?

Testing standards ensure that the medical device is fit for use not just for the patient but also for the healthcare professionals handling them. Most countries do not have stringent requirements for testing standards, but it is recommended that the devices have some form of tests done.

Why are risk management and testing standards closely linked?

Risk analysis is a crucial step in designing a medical device. Certain identified risks can be managed with a minor change in the initial stages of the manufacture and these can be identified with the help of an appropriate test.


Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

July Newsletter 2022

EUROPEAN UNION (EU)

Harmonised administrative practices and alternative technical solutions| 13 July 2022

The MDCG guidance document advises the Member States and other relevant parties on applying specific IVDR regulations in the absence of Eudamed. This guidance defines harmonised administrative processes and alternative technology alternatives for information interchange until Eudamed is entirely operational. Based on the appropriate provisions of Directive 98/79/EC, this guidance covers specific instances when information exchange would be difficult, if impossible, to execute.

Implementation of Regulation (EU) 2022/1107 for common specifications under Regulation (EU) 2017/746| 5 July 2022

The European Commission has established common standards for high-risk diagnostics, including HIV tests and SARS-CoV-2 assays. The guidelines establish uniform and stringent criteria for tests across the EU, clarifying the requirements for market participants and protecting EU patients. Annexes I to XIII of EU Regulation 2022/1107 specify the various standards to be met by Class D in vitro diagnostic medical devices in terms of performance characteristics. Annex XIII defines the standards for devices that detect or quantify markers of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. The EU Regulation 2022/1107 can be accessed here.

ITALY

Webinar on “CLV of cosmetic products – procedures and critical issues”| 11 July 2022

An online event titled “CLV of cosmetic products – procedures and critical issues” is organised by the Directorate General for Medical Devices and Pharmaceutical Service – DGDMF (Office 8) and is targeted at businesses in the industry interested in applying for Certificates of Free Sale (CLV) for “export of cosmetic products.” To know more on the topic, click here.

UNITED KINGDOM (UK)

Updated Guidance on Registering Medical devices in UK| 28 July 2022

Medicines and Healthcare products Regulatory Agency (MHRA) has updated its guidance on medical device registration in the UK. The guidance now contains a specific Coronavirus Test Device Approval (CTDA) section. Persons planning to supply, put into service, or place a coronavirus test device on the UK market must apply for clearance from the UK’s Health Security Agency (UKHSA).

The MHRA will not accept registration applications for covid test devices until they have received Coronavirus Test Device Approval (CTDA) or are placed on the Temporary Protocol list.

Over 285,000 medical devices and medicines seized in UK | 20 July 2022

In the latest press release by the Medicines and Healthcare products Regulatory Agency (MHRA), over 285,000 illegal drugs and medical devices were seized. The MHRA have seized large quantities of illegally traded medicines and medical devices in an Interpol week of action known as “Operation Pangea”.

Over £850,000 in medicines and medical devices, totalling over 285,000 items, have been seized by officers from the UK’s MHRA as part of a global operation to combat the illegal sale of medical products, with UK seizures estimated to be worth around 9% of the global total.

Guidance on Innovation Accelerator | 26 July 2022

Medicines and Healthcare products Regulatory Agency (MHRA) has released guidance on the Innovation accelerator, which aims to provide access to MHRA’s scientific expertise, regulatory assistance, and enhanced advice and signposting service for inventors and developers of novel products. It provides regulatory information, advice, and guidance to organisations of all sizes and backgrounds based in the UK or globally (industry, academics and patient groups).

The Innovation Office is open to queries from those developing innovative medicines, medical devices, manufacturing processes and blood components for transfusion.

Public consultation on future regulation of medical devices | 26 June 2022

MHRA has released a document on the future regulation of medical devices in the UK by MHRA. The document contains feedback from a wide demographic, including healthcare professionals and manufacturers. The highlights of this document include:

  • Possible reclassification of medical devices increased post-market surveillance of medical devices
  • Implementation of improved traceability of medical devices
  • Government to introduce Alternative market routes
  • Rescheduled CE marked devices acceptance and UKCA dates.

SWITZERLAND

New EUDAMED information Center launched | 21 July 2022

The European Commission has launched the new EUDAMED Information Center. It combines all EUDAMED Production User Guides, offers rapid and organised access to all relevant information, and includes a contact form for users to contact the EUDAMED Support Team. For more information, click here.

MedTech Europe Survey Report on MDR implementation| 20 July 2022

MedTech Europe performed a study with 475 responses from major and small businesses to quantify medical device availability. According to the findings, less than 15% of medical equipment has previously gained MDR certification. The time to certification has increased to 13-18 months, and more than 15% of SMEs still do not have access to an MDR-designated Notified Body. As a result, over half of respondents believe they will deprioritise the EU market for new device regulatory approval. The report discusses how MDR implementation will affect the EU medical device market.

Swissmedic information sheet on in-vitro diagnostic device notifications | 14 July 2022

Swissmedic has released an updated document on in vitro diagnostic medical devices. The information sheet answers some of the frequently asked questions on IVD notification. The document contains information on when the notification form for IVDs must be submitted, the timeline for processing the application and other important information.

AUSTRALIA

Unique Device Identification system: Communications and stakeholder engagement| 18 July 2022

The success of the UDI system needs to involve health professionals, healthcare organisations, consumers, and industry in its creation and implementation. The TGA will interact and consult with stakeholders to ensure that all viewpoints, notably those of medical device users, are considered. The TGA’s public reporting will guarantee that the TGA’s progress toward establishing the UDI system is transparent. Click here to access the latest webinar on UDI implementation.

Safety information on home use fetal dopplers (heartbeat monitor) | 07 July 2022

The TGA is now studying foetal cardiac monitors’ safety indicators, advantages, and disadvantages for home use. This review is shared with consumers and healthcare professionals. The TGA’s examinations will help assess whether utilising these gadgets carries more risk than the potential benefit.

Fetal dopplers are handheld devices that track the foetal heart rate between 10 and 12 weeks of pregnancy. Traditionally, health workers have employed these tools in clinical settings. Fetal dopplers for home usage have become readily accessible recently, and users don’t need special training to use them. The TGA is aware of instances in which Fetal dopplers for home use have led to patients receiving delayed medical care and false reassurance. The Royal Australian and New Zealand College of Obstetricians and Gynecologists and the US Food and Drug Administration (US FDA) have released guidelines on using these monitors. Both do not encourage the usage of home doppler equipment to detect the foetal heartbeat.

UNITED STATES OF AMERICA (USA)

Patient Labelling Recommendations for Laser-Assisted In Situ Keratomileusis (LASIK) Lasers | 27 July 2022

The content and formatting for patient labelling information for laser-assisted in situ keratomileusis (LASIK) devices are recommended in this guidance document. This guidance is to help ensure that both physicians and patients understand the benefits and dangers of these devices. The recommendations are issued in response to concerns that some patients are not receiving or understanding information about the benefits and hazards of LASIK equipment. The labelling suggestions mentioned in the document are meant to supplement, not replace, physician-patient discussions about the advantages and dangers of LASIK devices that are unique to patients.

Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices, Direct Marking, and Global Unique Device Identification Database Requirements for Certain Devices | 22 July 2022

In this guidance, the FDA modified the Global Unique Device Identification Database (GUDID) submission requirements for several class I devices considered consumer health goods. In particular, the FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I devices requiring a UDI on their labels and device packages because they are deemed consumer health items. Furthermore, the FDA does not intend to enforce the GUDID submission requirements under 21 CFR 830.300 for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices, before December 8, 2022, regardless of whether they are consumer health products (an additional 75 calendar days).

Medical Device Types for Section 506J Notification Obligation | 19 July 2022

FDA has updated the guidance containing suggestions based on the device types and corresponding product codes for manufacturers when they are required to notify FDA during the COVID-19 pandemic under section 506J. Section 506J of the FD&C Act requires manufacturers to notify the Secretary of a permanent discontinuance in the manufacture of certain devices or an interruption in the manufacture of specific devices that leads to a disruption in the supply of that device in the United States.

FDA has listed the device types and their corresponding product codes so that manufacturers can consider whether they are required to notify FDA during the COVID-19 pandemic under section 506J of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Tracking Premarket Submission’s Progress (Progress Tracker) | 18 July 2022

The Center for Devices and Radiological Health’s (CDRH) progress in assessing Traditional, Abbreviated, and Special 510(k) applications is tracked by the FDA using a secure, web-based tracker. Official Correspondent can now track the FDA’s progress online when you submit a 510(k) submission to CDRH for review in a clear, concise manner.

The FDA provides online progress tracking to uphold its obligations under the Medical Device User Fee Act (MDUFA). The application tracker can be accessed here.

510(k) Third Party Review Organization Performance Report for FY22 – Q3| 8 July 2022

The FDA Modernization Act of 1997 (FDAMA) established the Accredited Persons Program to enhance the effectiveness and timeliness of the FDA’s 510(k) procedure. As part of the programme, the FDA accredits Third Parties (Accredited Persons) qualified to perform the initial 510(k) reviews for admissible devices.

In accordance with MDUFA (Medical Device User Fee Act) IV, the FDA committed to publicly making online the performance of each accredited Third Party with at least five successfully submitted documents (e.g., the specific number of holds and the typical turnaround time for decisions). Every quarter, a summary of Third-Party Performance Metrics will be published. Data from FY 2018, Q1 through FY 2022, and Q3 are included in this study (October 1, 2017, through June 30, 2022). The report can be accessed here.

COSTA RICA

Health reform decree to simplify the registration of low-risk processed foods and cosmetics| 06 July 2022

The sanitary registration of processed foods and low-risk cosmetics will be made easier by an amendment to executive decree 43291-S. The operation, which formerly took 30 days to complete, must be finished immediately. According to Minister of Health Joselyn Chacón Madrigal, the purpose of this kind of reform is to make the nation more competitive to draw investment and facilitate business through digital governance. The list of cosmetic items has also been expanded to include items for the face (moisturising creams, masks, and powders), mouthwash, and alcohol solution for hand cleansing.

BAHRAIN

Bahrain Health Regulatory Conference on 27-29 September 2022| 26 June 2022

The National Health Regulatory Authority (NHRA) will hold Bahrain’s 2nd Health Regulatory Conference. Government healthcare decision makers, health reform and regulation experts, pharmaceutical and drug company owners, public and private healthcare providers, investors and interested experts in the healthcare business, technology experts, solution providers, and healthcare professionals will all be present at the exhibition. The exhibition will take place from 27th -29th September 2022.

This is an opportunity to exchange knowledge and thoughts while participating in an educational platform.

CHINA

China approves new domestically developed ‘artificial heart’| 17 July 2022

“Artificial heart” for severe heart failure developed in China has received commercial permission from the NMPA of China.

The TEDA International Cardiovascular Hospital and the China Academy of Launch Vehicle Technology collaborated to develop the artificial heart; they have been researching the third generation of ventricular assist devices in China since 2009.

According to the Annual Report on Cardiovascular Health and Diseases in China (2021), published in late June, there are 8.9 million heart failure patients in China. According to the report, 58 of the 68 medical devices that the NMPA authorised to join its “innovative medical device evaluation channel” between September 2020 and August 2021 were Chinese.

MALAYSIA

Full enforcement of medical devices regulations 2019 from July 2022| 01 July 2022

Malaysia’s Medical Device Authority (MDA) has announced that the Medical Devices Regulations 2019 will be implemented entirely from July 1, 2022.

With full enforcement of this Regulation, all parties involved in the importation, distribution, and placement of medical devices on the market are required to comply with all of the requirements set out in this Regulation, which generally set out post-market control requirements, such as complaint handling, mandatory problem reporting, corrective and preventive actions in the field (field corrective action) and recall for medical devices. Further information regarding labelling can be found here.

SINGAPORE

Consultation on Regulatory Guidelines for Laboratory Developed Tests (LDTs | 01 July 2022

An updated version of the Regulatory Guidelines for Laboratory Developed Tests (LDTs) has been made available by the Medical Devices Cluster (MDC) for stakeholder consultation. Under the Healthcare Services Act, clinical laboratories are currently subject to MOH regulation and licencing (HCSA). Considering the present regulatory requirements that apply to clinical laboratories under HCSA, the regulatory approach for LDTs will be based on the current regulatory standards applicable to commercial in-vitro diagnostic devices (IVDs).

The document provides an overview of the scope of LDTs and the regulatory requirements applicable, including Product controls, Manufacturing Quality controls and Post-market controls.

JAPAN

Health Science Council Pharmaceuticals and Medical Devices System Subcommittee to be held on 05 August 2022| 22 July 2022

A Subcommittee will be held on the 5th  of August 2022. The agenda includes:

  • Discussions on the revised Pharmaceuticals and Medical Devices Act
  • Working group on the work of pharmacists and the functions of pharmacies
  • Others relevant topics

Study Group on Early Introduction of Medical Devices with High Medical Needs will be Held | 20 July 2022

This study group aims to identify in-vitro diagnostic medications and medical devices with significant unmet medical requirements that are not licenced or indicated in Japan and to consider their fast introduction into clinical practice.

INDIA

Notice regarding non-notified medical devices | 11 July 2022

According to notification No. G.S.R. 102(E) dated 11.02.2020, all non-notified medical devices in the Class A and Class B categories are expected to enter the licencing regime by October 1, 2022. For Class A and Class B medical devices, a transition period of 30 months from the date of introduction of G.S.R. 102(E), i.e., 01.04.2020, has been provided for the transfer to the licencing regime.

In the notice, CDSCO strongly recommends that all manufacturers apply for a manufacturing licence for Class A and Class B medical devices using CDSCO’s online portal so that the manufacturing licence can be obtained from the various State Licensing Authorities following a review of the applications and audit.

Classification of medical devices pertaining to Rehabilitation under Medical Device Rule 2017| 06 July 2022

The requirements of the Drugs and Cosmetics Act of 1940 govern the safety, quality, and performance of medical devices. The Central Government has notified Medical Devices Rules (MDR) for regulating medical devices in import, production, clinical evaluation, sale, and distribution, following consultation with the Drugs Technical Advisory Board. The updated list of medical devices under MDR includes acupressure calf band and Arthritis TENS system, among other medical devices that aid rehabilitation. The complete list of medical devices and the product class can be accessed here.


Please note: Always refer to the regulations in the respective ministry of health website for authorised news and releases.

Requirements of Technical Documentation EU MDR

Requirements of Technical Documentation EU MDR

Technical documentation should contain details of the medical device in a clear, organized, readily searchable and unambiguous manner. It should be provided with all medical devices irrespective of the device class and to be kept updated throughout the product life cycle. Technical documentation is to be prepared according to the requirements given in Annex II of EU MDR 2017/745.

Requirements as per Annex II

  1. Device description and specification, including variants and accessories
  2. Information to be supplied by the manufacturer
  3. Design and Manufacturing information
  4. General safety and performance requirements
  5. Benefit-risk analysis and risk management
  6. Product verification and validation

Device description and specification, including variants and accessories

This section mentions that technical documentation must include all basic device details such as trade name, general description, Basic UDI-DI, principles of operations, classification details, accessories description, key functional elements, technical specification etc. There must also be a proper reference to previous or similar medical devices.

Information to be supplied by the manufacturer

This section mentions that manufacturer must include a complete set of labelling for the device and its packaging. The manufacturer must also ensure the language requirements of the same according to the each member states’ language requirements.

Design and Manufacturing information

This section mentions that the technical documentation shall include complete information on processes carried out by the manufacturer during the design stage, manufacturing, validation, monitoring and final product testing of the device. Identification details of all sites and people involved in the manufacturing process must also be made available.

General safety and performance requirements

This section mentions that the technical documentation must demonstrate conformity to general safety and performance requirements set out in Annex I of the MDR. This shall include details such as an explanation for safety and performance requirements that the device satisfies and an explanation for requirements that it does not meet, methods used to demonstrate conformity, harmonized standards, Common specifications, and the identity information of the control documents.

Benefit-risk analysis and risk management

This section mentions that the technical documentation shall include the benefit-risk analysis, solutions adopted, and risk management results as per Annex I of the MDR. Some significant points from the Risk management section of Annex I are

  • The risk management plan must be available for each device
  • Should be able to identify foreseeable hazards associated with each device
  • should be able to estimate and evaluate the risks
  • should have plans to eliminate/control the risks
  • should be able to assess the impact of risk at various stages of the device’s lifecycle and thereby estimating overall risk, benefit-risk ratio, and risk acceptability

Section 1 to 8 of Annex I gives detailed information on general safety measures and other risk management requirements.

Product verification and validation

This section mentions that the technical documentation shall contain results and critical analyses of all verification and validation tests/studies. Some significant Tests/studies discussed in the section are

  • Biocompatibility
  • Electrical Safety
  • Electromagnetic compatibility
  • Software verification and validation
  • Stability
  • Performance and Safety
  • Physical, chemical, and microbiological characteristics
  • sterility

A clinical evaluation report and a PMCF (Post-market clinical follow-up) plan and evaluation report must be available. Else, a justification for why PMCF is not applicable must be made available. Additional information required in specific cases is given in detail in Section 6.2 of Annex II of the EU MDR.

Post-Market Surveillance

Annex III of the MDR majorly mentions that the post-market surveillance plan must address the method of collection and utilization of available data (Such as information on serious incidents and their corrective actions, data on any undesirable side- effects and so on) and includes a list of details a post-market surveillance plan must include in the plan. There is also a reference to PSUR (Periodic safety update report) and post-market surveillance report mentioned in articles 86 & 85, respectively.

Significant Changes to be noted during the transition from MDD to MDR

  1. Device description to include UDI, UDI-DI or any such number for traceability reasons
  2. Reference requirements to previous or similar medical devices
  3. Under labelling requirements in the MDR, it is explicitly talks about the labelling of devices and their packaging
  4. Language requirements for labelling
  5. As per the MDD, only Class III devices required an explanation for design stages and procedures. The same is now updated to all classes of medical devices in MDR
  6. Identification requirements of all manufacturing sites, design including suppliers and contractors are required now
  7. General safety and performance requirements are updated versions of Essential requirements from the MDD
  8. The benefit-risk analysis is explicitly mentioned as part of risk management requirements in the MDR
  9. Product verification and validation requirements
  10. A detailed explanation of pre-clinical and evaluation and Clinical Evaluation requirements are provided in the MDR
  11. The requirements of the Clinical Evaluation plan and report, Post-market clinical follow-up plan and report are specially mentioned in the MDR
  12. Additional information for special case devices (e.g., combination device, sterile device, device with measuring function etc.) is mentioned in detail in the MDR

FAQs:

What are Common specifications?

Common Specifications are a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.

What is the UDI?

The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific medical device on the market. The UDI is comprised of the UDI-DI and UDI-PI. The unique identifier may include information on the lot or serial number and be able to be applied anywhere
in the world.

What is the Basic UDI-DI?

Basic UDI-DI is intended to identify and connect devices with the same intended purpose, risk class and essential design and manufacturing characteristics. It is independent/separate from the packaging/labelling of the device and it does not appear on any trade item

Is Post-market surveillance (PMS) applicable for only higher risk classes?

PMS is required for all device classes. A PMS plan and report to be maintained and kept updated by the manufacturer throughout the device life cycle.


Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.

Exceptional Use Medical Devices in the EU and UK

Exceptional Use Medical Devices in the EU and UK

Medical devices conforming with the medical device regulations must have a conformity marking. Medical devices that do not conform may still be placed in the market, provided they apply through the exceptional use devices pathway. This article discusses the exceptional use requirements to be satisfied to gain access to EU and UK markets.

In the UK, the UKCA marking displays that the device conforms to UK Medical Device Regulations 2002. Without UKCA marking, the devices can only be placed in the market under certain circumstances. Similarly, CE marking is accepted throughout the EU, which denotes that medical device conforms to the EU MDR 2017/745. This procedure may also apply to custom-made devices that have not complied with standard conformity procedures. These devices are called special-purpose devices in the EU and are mentioned in Article 21 of EU MDR 2017/745.

Exceptional devices in the UK

Medicines and Healthcare products Regulatory Agency (MHRA) regulates medical devices as per UK MDR 2002. The MHRA may authorise non-compliant devices, but this is done on a case-by-case basis.

A manufacturer may place a medical device if the following conditions are met:

  • The clinician supports the application for the treatment of the patient
  • No alternative to this medical device is available on the market
  • Justification on how the medical device can improve the patient’s health with the device

The manufacturer is responsible for placing the device on the market, but the manufacturer and clinician must fill out the Humanitarian use of device-application form and submit to [email protected] . The application form must be submitted for each different patient. MHRA approves the case-by-case application basis and may request more information if the application details are deemed unclear.

The application form for exceptional use devices requires the following details:

  • Name and address of the manufacturer
  • Generic name of the device
  • Clinical investigation details
  • Risk analysis, hazard identification and estimation of risks
  • Name and address of the consultant
  • Patient’s medical condition details
  • Device necessity and
  • Other relevant information  

Devices for special purposes in the EU

Devices under this category do not require a CE mark. Still, they must meet the conditions mentioned in EU MDR that the device is evaluated for its safety and effectiveness by the manufacturer. Articles 62-82 of EU MDR describe the requirements to be met by manufacturers of investigational devices.

Firstly, for investigational devices, a proper clinical investigation plan is required. Read our detailed article on Clinical investigation in the EU for more information regarding this topic. In short, the clinical investigation has a different technical file and application form than the CE-marked medical devices.

The application form should be submitted with the following documents.

  • Clinical investigation plan
  • Investigator’s brochure
  • Name and address of the manufacturer
  • Patient information sheet
  • Detailed risk analysis and test reports
  • Informed consent document
  • Other available technical documentation

Custom-made devices

As per EU MDR, ‘custom-made devices’ means as any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their conditions and needs. However, the definition does not include ‘mass produced’ devices that need to be adjusted per user requirements. UK MDR 2002 5 (1) has a similar definition for custom-made medical devices. The provisions in Great Britain (England, Wales and Scotland) can be accessed in Guidance on Custom-made devices in GB. Medical devices like dental appliances and prosthetics all come under custom-made devices as these are designed specifically for an individual and are not mass-produced.

Custom-made devices require technical documentation following Annex II and III of EU MDR. In addition to the documents, the manufacturer or authorised representative should draw a statement containing crucial information like that the device is intended for exclusive use by a particular user and data allowing unique identification of the medical device.

An important point to remember is that custom-made devices must conform to general safety and performance requirements in Annex I of EU MDR and essential requirements in Annex I Schedule 2A of the UK MDR 2002, and the devices are not exempt from these requirements.

FAQs

What devices come under custom-made devices?

Medical devices that come under Custom-made devices are specifically designed for an individual patient. Some great examples include dental crowns, fillings, elastics and retainers for dental structure or health. Other devices such as artificial eyes and maxillofacial implants like craniofacial implants, auricular, nasal implants, hearing aids and orthopaedic footwear fall into this category. The healthcare professionals must take accurate impressions of patients so that the device is a custom fit for the end-user or patient.

What is the difference between a custom-made device and an investigational device?

Investigational devices are those that are research devices that are developed that have no market equivalent. These devices are subjected to a clinical study to check product effectiveness. On the other hand, custom-made devices are not subject to clinical research but are customised according to the patient’s requirements. Both investigational devices and custom-made devices do not require CE/UKCA marking and require exceptional devices regulatory approvals to enter the respective markets.


Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.