EUROPEAN UNION (EU)
Guidance on EU Authorized Representatives | 31 October 2022
Medical Device Coordination Group has updated its guidance on Authorized Representatives under MDR 2017/745 and IVDR 2017/746. Under both MDR and IVDR, it is a requirement for manufacturers based out of the European Union to appoint an Authorized representative. The MDCG 2022-16 document further includes the following topics:
- Designation and mandate
- Registration and verification obligation
- Minimum tasks and responsibilities
- Change of Authorized representative and termination of the mandate
Guidance on Requirements relating to notified bodies | 27 October 2022
The requirements for notified bodies under Regulations (EU) 2017/745 on medical devices (MDR) and (EU) 2017/746 on in vitro diagnostic medical devices are discussed in this document’s questions and answers. The topics included in this paper have been determined through joint assessments, and it may occasionally be updated as new issues are found. The document answers the questions relating to major topics such as:
- Organization and general requirements of Notified bodies
- Quality management system requirements
- Resource requirements
- Process requirements
- Other requirements for Notified bodies
Notified bodies survey on certification and applications | 26 October 2022
The European commission’s latest survey on certification and application under MDR and IVDR has been released. The survey discloses the following vital information:
- Total number of valid certificates under MDD and AIMDD- 22,793
- Total MDR applications 8,120
- Total MDR certification 1,990
- Main reasons for MDR certification refusal
- Time required for MDR certification is approximately 13-18 months
- Total valid IVDD certificates 1,551
- IVDR application and certification
- Main reasons for IVDR certification refusal
- Time required for IVDR certification is approximately 13-18 months
Expert decision and opinion in the context of the Clinical Evaluation Consultation Procedure | 20 October 2022
The scientific opinion reflects the views of independent experts on the clinical evaluation assessment report (CEAR) of the notified body. The advice is provided in the context of the clinical evaluation consultation procedure (CECP), which is an additional element of conformity assessment by notified bodies for specific high-risk devices. This expert opinion is on the Class III implantable device which is resorbable sterile mesh. Although the device is not novel, an expert opinion was issued as there was insufficient data whether the device is safe for use. These devices usually show complications over time.
Position paper on Notified Body Transfer agreement | 05 October 2022
The terms of the transfer agreement of Notified body under EU MDR 2017/745 and IVDR 2017/746 is now released. The agreement contains the responsibilities of incoming and outgoing notified bodies.
Class D measures in the absence of EU Reference Laboratories | 05 October 2022
The scope of this position paper is to provide a framework for the verification process for class D IVD medical devices by Notified Bodies (NB) in the absence of designated EU Reference Laboratories
(EURLs). It includes both the verification during the Technical Documentation review prior to certification and of manufactured products post-certification. This position paper reviews possible solutions and implementation measures, however, it is entirely up to a NB to decide what / which methods and solutions are used, if they would like to progress Class D applications in the absence of EURLs.
Position paper on Cybersecurity | 05 October 2022
The increasing number of connected medical devices and ongoing digitisation in healthcare bring new market opportunities for manufacturers and, more importantly, improvements in patient care. The position paper contains Team NB’s recommendations to improve cyber security.
Position paper on Off-label use of medical devices | 05 October 2022
Off-label use is cited in the Medical Device Regulation (MDR) in Annex XIV Part B in the context of manufacturers’ responsibility to proactively identify misuse or off-label use of their devices through PMCF activities, however, neither “off-label use” nor “misuse” are defined in the MDR. This position paper defines “Off-label use” of a medical device as a device used outside of the approved instructions for use including indications. Specifically, off-label use of a device outside the approved indications could include the use of a device.
- Outside specified populations such as paediatrics;
- For a different stage or severity of the disease
- For a similar (not identical) clinical condition
- Being introduced to the body through alternative routes
Position paper on Submission of Technical Documentation | 05 October 2022
To create a common perspective on the requirements of technical documentation submissions from manufacturers, members of Team NB reviewed the best practise guidance documents that each Team NB notified body member had submitted. They then prepared this best practise guidance document.
The requirements of the Medical Devices Regulation [MDR] (EU) 2017/745, which are in-depth explained in Annexes II and III of Regulation (EU) 2017/745, are linked with this technical documentation submission advice. The document describes the contents of device and description, information supplied by the manufacturer, general safety and performance requirements, risk management and others.
Guidance on Custom-made devices | 05 October 2022
The Department of Medical Devices informs about the publication of the Czech version of MDCG 2021-3 – Questions and answers to custom-made medical devices.
Regarding the annual review and proposed fees for 2023, the HPRA is looking for feedback. Consultation will begin on October 4, 2022. The consultation period will end on October 29, 2022. All interested parties are encouraged to respond to the consultation, which is viewable on Consultations webpage. Response documents will be issued providing a basic overview of the comments received and the changes made to the proposals as a result.
UNITED KINGDOM (UK)
Implementation of the Future Regulations | 25 October 2022
According to the government statement, the upcoming Medical Device Regulations will significantly alter the existing framework. The government is committed to making sure that its deployment is done in a way that enhances system preparedness and reduces the chance that UK patients may experience supply disruptions. To have the new regulations in effect by July 2024, we are introducing a 12-month extension to the implementation of the future medical device regulations.
The acceptance of CE-marked products on the British market is set to stop on June 30, 2023, according to the current Medical Device Regulations 2002 (UK MDR 2002). This has now changed. The transitional measures outlined in the government response indicate an expansion of the acceptance of CE-marked medical devices sold on the British market, which is anticipated to be reflected in the revised UK MDR 2002.
After July 1st 2023, manufacturers will still be permitted to sell CE-marked products in Great Britain. The interim measures will be in effect starting in July 2024 for devices with the CE and UKCA markings that are sold in the United Kingdom.
Software and AI as a Medical Device Change Programme – Roadmap | 17 October 2022
Software, including artificial intelligence (AI), is crucial to the social and health care sectors. Numerous of these items are governed as medical devices in the UK. In order to guarantee that the regulatory requirements for software and AI are clear and that patients are safeguarded, the MHRA announced the Software and AI as a Medical Device Change Program last year. The Government’s answer to the consultation on the potential future regulation of medical devices in the United Kingdom outlines broader reforms for medical devices as a whole, which this programme builds upon. Additional details on each work package of the Change Programme, including deliverables to satisfy each group of broad objectives, are provided below. Also, additional details on how the wide Change Programme will be implemented are also provided.
- Software and artificial intelligence (AI) medical device requirements ensure that these devices are acceptably safe and work as intended, protecting patients and the general public.
- The demands placed on manufacturers are obvious, supported by both explanatory instructions and streamlined procedures that apply to software, and strengthened by the resources needed to prove compliance, such as the designation of standards.
By collaborating with important partners like NHS England and the National Institute for Health and Care Excellence (NICE), we can coordinate domestically, eliminate duplication, and integrate requirements to provide a joined-up solution for digital health in the UK. Through the International Medical Device Regulators Forum (IMDRF), we will collaborate with other regulators globally to strengthen global convergence and consensus on software and AI products.
Registration guide on MORE portal registration | 14 October 2022
Medical device adverse incidents which occur in the UK must be reported to the MHRA. Post-market vigilance reports are currently submitted by the MORE system or by emailing a Manufacturer Incident Report (MIR) form to the MHRA.
The Manufacturer’s On-line Reporting Environment (MORE) portal registration process via MORE and managing organisation setup are both covered in the paper. Each organisation must have an initial lead user (also known as a “Organisation Lead”) whose registration must be approved by the MHRA. The MHRA will only execute registration requests if the initial user is already registered on the existing legacy MORE system or if supporting paperwork has been provided for individuals who don’t have an account yet.
MHRA Consultation to improve medicines and medical devices’ safety | 13 October 2022
To increase the safety of medications and medical devices, the MHRA is reevaluating how it engages with healthcare practitioners. This consultation closes at 11:45PM 18 January 2023. We want to make sure that healthcare professionals are getting practical knowledge and advice on how to handle medications and medical equipment safely that they can implement into their daily work practises and utilise to give patients prompt assistance.
Guidance for manufacturers on vigilance | 06 October 2022
MHRA has released an updated guidance for manufacturers on vigilance. Modifications to the incident reporting process:
The Manufacturer Incident Report (MIR) form’s XML output, sent to [email protected], or the MORE system are the two ways that manufacturers must submit post-market vigilance reports to the MHRA. This will alter as of November 21, 2022. The new MORE portal or our own Application Programming Interface (API) for direct reporting from your internal systems are the only ways to report adverse occurrences for devices to the MHRA.
Swissmedic update on CHREP audits | 25 October 2022
Foreign medical device manufacturers who want to sell their products in Switzerland must appoint a Swiss authorised agent (CH-REP). The CH-REP is jointly and severally liable for the devices with the manufacturer in all interactions with Swissmedic, cantonal authorities, and patients.
In order to monitor how Swiss approved representatives were putting the regulations into practise on the market, Swissmedic conducted focused, methodical inspections of them in the first half of 2022. A randomly selected sample of 20 Swiss authorised representatives who had registered with Swissmedic nationwide was inspected by Swissmedic between March and May 2022. For the purpose of obtaining a broad picture of the market environment, information was gathered, including details on their operating models. The three official Swiss languages as well as English were used throughout the inspections.
UNITED STATES OF AMERICA (USA)
FDA guidance on developing and responding to deficiencies | 21 October 2022
In compliance with the Least Burdensome Provisions of the Food, Drug, and Cosmetic Act, the latest guidance document assists Food and Drug Administration (FDA) staff in creating a request for more information (FD&C Act). A “deficiency” is the term for such an FDA request for additional information. In order to make the best use of both industry and FDA’s time, this advice also offers suggested formats for FDA personnel to utilise when communicating shortcomings and for industry to use when responding to such requests. For the purpose of facilitating a productive review process, the guidance contains illustrations of well-constructed flaws and industry answers. The guidelines also cover supervisory evaluation, major/minor problems, extra factors, and the order in which deficiencies in FDA deficiency letters should be addressed.
Webinar – Clinical Decision Support Software Final Guidance | 18 October 2022
FDA hosted a webinar for representatives and other interested parties to talk about and ask questions regarding the final guidance on clinical decision support software. The guidance:
- Explains the scope of the FDA’s regulatory control of clinical decision support (CDS) applications designed for medical practitioners.
- Explains that software features that match the definition of a medical device, including those that are intended for use by patients or caregivers, continue to be subject to the FDA’s current digital health standards.
- Examples of CDS functions and software functions for devices that are not hardware.
Further information on the webinar can be accessed here.
CDRH -Total Product Life Cycle Advisory Program Pilot Launch | 11 October 2022
The Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot is being launched, according to an announcement from the FDA’s Center for Devices and Radiological Health (CDRH). TAP is a voluntary programme that aims to reduce the risk of the “medical device valley of death” by giving industry earlier and more frequent interactions with CDRH, more strategic stakeholder input, and proactive, strategic advice from CDRH to encourage more rapid development of high-quality, safe, effective, and innovative medical devices that are crucial to public health.
Position paper on Cybersecurity | 05 October 2022
The increasing number of connected medical devices and ongoing digitisation in healthcare brings new market opportunities for the manufacturer and, more importantly, improvements in patient care. The position paper contains Team NB’s recommendations to improve cyber security.
Guidance on Post market surveillance requirements | 07 October 2022
FDA has issued the latest guidance on post market surveillance requirements under Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Important public health concerns about a device’s effectiveness and safety are addressed with the help of the data gathered as part of a surveillance order. This guidance document is intended to provide guidance to manufacturers of devices subject to Section 522 post-market surveillance orders.
Post-Approval Studies Program | 06 October 2022
When approving a Premarket Approval Application (PMA) or Humanitarian Device Exemption (HDE) application, the FDA may ask for a post-approval study (or studies) to help assure the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of the approved device. Device approval is subject to post-approval investigations. If a sponsor doesn’t follow any post-approval requirements, the FDA may revoke its approval. (Note: A PMA or HDE approval order may require more than one post-approval study for a device.)
The guidance contains the following information:
- Post-Approval Studies (PAS) Database
- Obtaining PMA Approval Letters, PAS Protocols, or PAS Final Reports
- Contact Information
Medical Device User Fee Amendments | 05 October 2022
FDA has released an updated list of fees applicable for different available application types under FDA. The list contains the updated fees for standard applications and fees applicable for small businesses. All establishments must pay the establishment registration fee. There are no waivers or reductions for small establishments, businesses, or groups. The FDA has also updated its guidance on Device registration and listing.
Source: Medical Device User Fee Amendments (MDUFA) | FDA
Updated guidance on eCopy Medical Device Submissions | 03 October 2022
FDA has updated the guidance on electronic copy (eCopy). It is a duplicate device submission that was previously required to be sent to the FDA in paper copy format. Electronic submissions do not include electronic copies. More information on this topic can be accessed here.
FAQ document on Software as a medical device | 19 October 2022
The document with questions and answers regarding the content of the Resolution of the Collegiate Board of Directors RDC 657/2022 is now available for consultation, which provides for the regularization of software as a medical device (Software as a Medical Device – SaMD ).
The document gathers the main questions received through the Anvisa Service System and the Fale Conosco, in order to clarify the most important points of the normative act.
Questions and answers about RDC 657/2022 can be accessed here.
Anvisa publishes a panel of Implantable Cardioverter Defibrillators | 06 October 2022
The Economic Monitoring Panel for Implantable Cardioverter Defibrillators (ICD) is now available for consultation, which covers medical devices registered with Anvisa under three technical names and allows personalized searches. The panel tends to facilitate the definition of reference prices for public or private purchases.
The resource makes it possible to group medical devices with similar characteristics, based on filters of specific technical attributes. According to the selected filter, the panel displays historical price statistics for these devices in federal public purchases, from July 2020 to June 2022, respecting the lag established by paragraph 4 of art. 22 of the Resolution of the Collegiate Board of Directors (RDC) 478/2021.
It is worth noting that the panel covers medical devices registered with Anvisa under three technical names that appear in IN 84/2021, and which had the set of technical attributes published in the annex of IN 119/2022.
The availability of the panel is part of the strategy for disseminating the results of economic monitoring of medical devices, according to RDC 478/2021.
Draft guidance for custom-made devices | 27 October 2022
The Medical Device Authority (MDA) created this guidance document to aid the healthcare community and the industry in adhering to the Medical Device Act’s (Act 737) regulations and requirements. The Medical Device Act 2012 (Act 737), Medical Device Regulations 2012, Medical Device (Duties and Obligations of Establishments) Regulations 2019, and Medical Device (Advertising) Regulations 2019 should be read in conjunction with this guidance document. Public Feedback and comments should be made by 09th November. The document can be accessed here.
Classification of devices pertaining to Oncology | 11 October 2022
Central Drugs Standard Control Organisation CDSCO has updated the list of oncology medical device and their classification under the Indian Medical device Rules 2017.The list includes devices like FerriScan R2-MRI Analysis System, alternating electric field antimitotic cancer treatment system generators and other devices. The list is dynamic and is subject to revision.The complete list can be accessed here.
Classification of Medical device pertaining to Dental | 10 October 2022
Central Drugs Standard Control Organisation CDSCO has updated the list of dental medical device and their classification under the Indian Medical device Rules 2017.The list includes devices like dental impression material, dental collars, dental examination kit, dental excavatos and much more. The list is dynamic and is subject to revision.The complete list can be accessed here.
Anvisa publishes guidelines on microbiological control of cosmetics | 04 October 2022
The Resolution of the Collegiate Board of Directors (RDC) 752/2022 came into force , which deals with the regularization of personal hygiene products, cosmetics and perfumes. This is the first stage of adaptation of these products. The measures are already valid for new regularizations and for labeling changes. In addition to the technical requirements and procedures for regularization, labeling and packaging, the new standard defines the parameters for microbiological control of these products. To clarify doubts regarding this item, provided for in article 28 of the RDC, and to speed up the analysis, Anvisa published Technical Note 31/2022/SEI/GHCOS/Dire3/ Anvisa.
The note provides guidelines on compliance with the mandatory technical requirement “microbiological specifications of the finished product”, where Anvisa clarifies the need to present:
- In the case of a product susceptible to microbiological contamination, data related to the microbiological specifications of the finished product, which must meet the microbiological control parameters present in Chapter V, of RDC 752/2022; or
- In the case of a low susceptibility product, a technical justification that demonstrates the reasons why the product has low susceptibility to microbiological contamination, suggesting, therefore, the use of ISO 29621:2017 Cosmetics-Microbiology Guidelines for the Risk Assessment and Identification of Microbiologically Low-risk Products, and its updates, as well as scientific literature relevant to the topic.
EUROPEAN UNION (EU)
EU Updates the Cosmetics Regulation Annexes | 28 September 2022
EU Commission has published Regulation (EU) 2022/1531 amending Cosmetics Regulation (EC)1223/2009, by updating Annexes II, III, and V with regards to the use of certain substances that have been classified as Carcinogenic, Mutagenic or Toxic for Reproduction (CMR). The amended regulation can be accessed here.
List of Updated ISO standards for October 2022
- ISO 16976-2:2022 Respiratory protective devices — Human factors — Part 2: Anthropometrics
- ISO 5467-1:2022 Dentistry- Mobile dental units and dental patient chairs-Part 1: General requirements
- ISO 5467-2:2022 Dentistry- Mobile dental units and dental patient chairs-Part 2: Air, water, suction and wastewater systems.
- ISO 7010:2019/Amd 6:2022-Graphical Symbols-Safety and colours and safety signs-Amendment 6
- ISO 18416:2015/Amd 1:2022-Cosmetics — Microbiology — Detection of Candida albicans — Amendment 1
Disclaimer: Regulations/legislations are subjected to changes from time to time and the author claims no responsibility for the accuracy of information.