EUROPEAN UNION (EU)
MDCG guidance on vigilance terms and concepts of EU MDR | 14 February 2023
The MDCG 2023-3 guidance document clarifies some of the essential terms and concepts in Section 2 of Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR). The topics covered in the guidance document are as follows:
- Difference between Incident and Serious incident
- Reportability under EU MDR
- Definition of malfunction or deterioration in the characteristics or performance of a device with examples
- Use error vs abnormal use
- Timelines to report an incident
MDCG Guidance on Classification of IVD under IVDR | 10 February 2023
The MDCG 2020-16 rev.2 guidance addresses the requirement for the classification of IVDs under the classification rules set out in Annex VIII. This document’s primary purpose is to guide manufacturers, notified bodies and health institutions on how to classify an IVD before placing it on the market, making it available on the market or putting it into service in the Union. It is also intended to inform regulators and other stakeholders when assessing the class attributed to an IVD by a manufacturer or a health institution. More information about IVD classification rules can be found here.
Guidance on implementation of Article 97 in Czech Republic | 02 February 2023
If you supply the Czech market with a medical device to which the procedure according to Article 97 of the MDR has been applied by the competent authority of another Member State due to the expiry of the validity of the EC certificate issued according to Directive 93/42/EEC or 90/385/EEC and the not yet existing EC certificate according to the MDR , it is necessary to request a decision of the competent authority on this procedure from the manufacturer of the medical device in question. This decision temporarily replaces the missing EC certificate and declaration of conformity, by which the manufacturer proves the conformity of the medical device with the relevant legislative requirements
BfArM Guidance on Companion diagnostics (CDx) | 08 February 2023
A companion diagnostic (CDx) is defined in article 2(7) of IVDR 2017/746 as follows:
“companion diagnostic” means a device which is essential for the safe and effective use of a corresponding medicinal product to:
- Identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
- Identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product
Whether an IVD fulfils the criteria of a CDx depends on whether detecting the biomarker status is necessary for the therapy decision to ensure the safe and effective use of the medicinal product. The analytical quality of detecting a certain biomarker is not a sufficient criterion for a CDx.
The guidance further introduces the special regulatory requirements, consultation procedure, risk assessment and performance studies with companion diagnostics. Further information can be found here.
HPRA process for Article 97 and notified body certificates | 13 February 2023
In December 2022, the Medical Device Coordination Group published Guidance (2022-18) on the use of Article 97 of the Medical Devices Regulation (MDR). The guidance allows for a controlled period of non-compliance for certain devices affected by the capacity challenges of notified bodies under specific conditions. Health Products Regulatory Authority (HPRA) has developed a process to use Article 97 for expiring or expired Directive certificates subject to meeting specific criteria. It will be used as a short-term measure to avoid disrupting the supply and availability of medical devices and healthcare in Ireland. Irish-based manufacturers or authorised representatives who meet the criteria can submit a request form for each certificate affected and pay the relevant fee. This process will continue until the EU Commission’s proposed legislative amendment to Article 120 of the MDR is adopted.
Clinical trials of medicinal products and medical devices | 08 February 2023
European Regulation 536/2014 on clinical trials is fully implemented for medicinal products and medical devices. Specifically, with the Decree of the Minister of Health of 26 January 2023, subject to agreement in the State-Regions Conference, the 40 territorial Ethics Committees are identified that have the task of evaluating clinical trials on medical devices and medicines for human use, also thanks to the virtuous synergy developed between the Ministry, AIFA, Regions and Autonomous Provinces.
The Decree of the Minister of Health of 27 January 2023 also regulates the transitional phase in relation to the evaluation activities and the methods of interaction between the Coordination Centre, the territorial Ethics Committees, the Ethics Committees of national importance and the Italian Medicines Agency.
The regulatory harmonization decree was also signed, which regulates, in particular, the functions of the Ethics Committees, the criteria for the division of competences between territorial Ethics Committees and Ethics Committees of national importance, the criteria for the composition of the Ethics Committees, in order to ensure that the members are in possession of documented knowledge and experience in clinical trials of medicinal products and medical devices, also in order to guarantee its independence.
Breast implant national registry | 02 February 2023
On 2 February 2023, the Regulation establishing the National Register of Breast Prosthetic Implants, comes into force.
The National Register of Breast Prosthetic Implants feeds on data from regional registers. The Regions and Autonomous Provinces have 180 days from 2 February to establish regional and provincial registers. By 01 August 2023, the National Register of Breast Prosthetic Implants will receive data from each area of the territory.
Italy is the first country in the world that has a mandatory feeding register by surgeons who implant or remove prostheses on the national territory. Even the economic operators who distribute these devices in Italy are required to transmit the data relating to each individual breast implant marketed and intended to be implanted, both for aesthetic and reconstructive purposes.
Amendment of Federal Law of the Russian Federation about advertising | 20 February 2023
Federal service for Surveillance in Healthcare (Roszdravnadzor) has amended the Federal Law of the Russian Federation dated 13.03.2006 No. 38-FZ about advertising. The law is applicable to medical devices supplied in the Russian market. The objectives of this Federal Law are:
- To develop markets for goods, works and services on the basis of compliance with the principles of fair competition,
- To ensure the unity of the economic space in the Russian Federation,
- To exercise the right of consumers to receive conscientious and reliable advertising,
- To create favourable conditions for the production and distribution of social advertising,
- To prevent violations of the legislation of the Russian Federation on advertising,
- To suppress the facts of improper advertising.
UNITED KINGDOM (UK)
Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU | 20 February 2023
The EU is introducing more time to certify certain medical devices under EU Medical Device Regulation (“EU MDR”). The proposal recognises the challenges in capacity across notified bodies. Key changes include:
- Extend the transitional period for higher-risk devices (class III and certain class IIb implantables) such as pacemakers to comply with EU MDR requirements until 31 December 2027, subject to certain conditions.
- Extend the transitional period for medium and lower-risk devices (other class IIb devices, class IIa, class Im, Is and Ir devices) such as syringes to comply with EU MDR requirements until 31 December 2028
- Extend the validity of certificates issued by notified bodies under Directive 90/385/EEC and 93/42/EEC that were valid on 26 May 2021
The UK Medicines and Healthcare products Regulatory Agency ( MHRA ) is carefully considering the implications of these revisions for the acceptance of CE-marked medical devices on the Great Britain (GB) market. At present, a device with a valid CE mark can be placed on the GB market until 30 June 2023. That would include certificates valid under the latest EU’s revised transitional arrangements if they are adopted as proposed. There are plans to extend acceptance of the CE marking in GB, but the official MHRA announcement is yet to be released.
UNITED STATES OF AMERICA (USA)
FDA Guidance on Adult Portable Bed Rail Safety | 27 February 2023
Many people use adult portable bed rails to help create a supportive and assistive sleeping environment in homes, assisted living, and residential care facilities. The guidance provides information on the risks of adult portable bed rails, recommendations for their safe use, alternatives to bed rails, and how to report medical device problems to the FDA.
Consumers can purchase many adult portable bed rails on websites and in stores without a prescription and without the recommendation of a health care provider. Adult portable bed rails marketed for medical purposes, such as those intended to assist individuals who are disabled, injured, or recovering from surgery or hospitalized with transfer in and out of bed or repositioning, intended to reduce the risk of falling or fracture or mitigate the risk of falling due to the effects of balance disorders or other medical conditions are considered medical devices regulated by the U.S. Food and Drug Administration (FDA) (see 21 CFR 890.5050 Daily activity assist device, product code, QTC Adult Portable Bed Rails for Medical Purposes).
FDA guidance on Medical Device Misconnections | 23 February 2023
FDA has recognized voluntary consensus standards for certain medical device connector designs intended to enhance device safety, such as the ISO 80369 series. Many connectors that rely on the ISO 80369 standards are currently available and incorporated into product-specific standards.
Connectors that conform to these standards are designed to help reduce the risk of medical device misconnections.
FDA guidance on Compliance Programs | 23 February 2023
FDA’s compliance programs provide guidance to FDA personnel for activities to evaluate industry compliance with the Center for Devices and Radiological Health. Some key compliance programs are available for Medical devices/Radiological health as follows:
- Inspections of CDER-led or CDRH-led Combination Product
- Inspection of Medical Device Manufacturers
- Medical Device Premarket Approval and Post market Inspections
- Mammography Facility Inspections
- Inspection and Field Testing of Radiation-Emitting Electronic Products
- Field Compliance Testing of Diagnostic Medical X-Ray Equipment
- Inspection of Domestic and Foreign Manufacturers of Diagnostic X Ray Equipment
- Compliance Testing of Electronic Products at WEAC
FDA guidance on Laser Products | 16 December 2022
The guidance introduces the Food and Drug Administration’s (FDA) regulatory requirements for compliance with performance standards for laser products. FDA regulates radiation-emitting electronic products, including all types of lasers products. Laser product means any manufactured product or assemblage of components which constitutes, incorporates, or is intended to incorporate a laser or laser system. A laser or laser system that is intended for use as a component of an electronic product shall itself be considered a laser product. The Agency sets radiation safety product performance standards that must be met by manufacturers in order for laser products to be legally sold in the U.S. market. Laser products may fall under both the definition of a medical device and that of an electronic product, of the FD&C Act.
FDA guidance on Medical X-Ray Imaging Devices conformance with IEC standards | 21 February 2023
The guidance introduces the FDA’s policy regarding the regulation of medical x-ray imaging equipment that is subject to the Federal Food, Drug & Cosmetic Act (FD&C Act) and FDA’s regulations that apply to medical devices and electronic products. In this guidance, FDA is seeking to harmonize performance standards prescribed pursuant to section 534 of Subchapter C (Electronic Product Radiation Control (EPRC)) of the FD&C Act with International Electrotechnical Commission (IEC) standards, where appropriate, to help to ensure efficient and consistent regulatory review of submissions for these products.
FDA guidance on Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices| 21 February 2023
This guidance document recommends 510(k) submissions for ultrasonic diathermy devices. Ultrasonic diathermy devices are devices under section 201(h) of the Federal Food, Drug and Cosmetic Act (the FD&C Act). This includes recommendations on using International Electrotechnical Commission (IEC) standards in generating information that can support 510(k) submissions for these devices. This guidance also provides guidance on other FDA documents regarding the specific content requirements and recommendations of a premarket notification (510(k)) submission (also refer to 21 CFR 807.87). Considering the points mentioned in the guidance before submitting a 510(k) submission for such Ultrasonic diathermy devices is crucial.
Updated guidance on Reclassification of medical devices | 28 February 2023
Therapeutic Goods Administration (TGA) has released a guide to assist sponsors of medical devices that are substances for introduction into the body with meeting their obligations and outlines transitional arrangements to help comply with new regulations.
From 25 November 2021, medical devices that are substances for introduction into the body will be required to meet regulatory requirements demonstrating the safety and performance of Class IIa (low-medium risk) or Class IIb (medium-high risk) devices.
This guidance is specific to medical devices composed of substances or combinations of substances intended to be introduced into the body via a body orifice or applied to and absorbed by the skin.
Updated guidance on Essential Principles-consent for non-compliance | 16 February 2023
There are Criminal Offences under section 41MA and Civil Penalties under section 41MAA of the Therapeutic Goods Act 1989 for persons who import, supply or export medical devices that do not meet the Essential Principles for safety and performance.
However, extenuating circumstances may prevent compliance with one or more parts of an Essential Principle for a limited period of time.
In such circumstances, sponsors may request consent to import, supply or export medical devices which do not meet an Essential Principle. The guidance is updated with the lastest requirements for applying for consent for non-compliant products.
Anvisa notification to check medical device documentation | 14 February 2023
The latest Resolution of the Collegiate Board (RDC) 751/2022 replaces the older Resolution of the Collegiate Board (RDC) 185/2001. The new standard provides for risk classification, reporting and registration regimes, labelling requirements, and instructions for the use of medical devices.
RDC 751/2022 promotes the internalization of Mercosur GMC Resolution No. 25/2021, which, at the initiative of Brazil, updated the document requirements and classification rules for medical devices applicable to the region. In addition to the internalization of the norm, the text consolidates a series of other regulations issued by Anvisa that deal with the regularization of medical devices.
MDA Guidance on notification of custom-made medical devices products | 01 March 2023
The Medical Device Authority of Malaysia has released a guidance to help the industry and healthcare professionals comply with the Medical Device Act (Act 737) and its regulations. The guidance provides information on the requirements of custom-made medical devices that are eligible to be exempted under the Medical Device (Exemption )Order 2016. The requirements include:
- Devices must meet the criteria of the custom-made medical device, including obtaining the written prescription and specific design characteristics from a healthcare professional
- Classification of the device according to the device classification as specified in the First Schedule of Medical Device Regulation 2012;
- The device is safe and performs as intended.
Notification of Amendment in the Medical Devices Rules, 2017 | 27 February 2023
Medical devices are subject to enlistment and registration under the Drug Regulatory Authority of Pakistan (DRAP). Medical devices are exempt from enlistment and registration requirements under these rules for a period until December 2023 and 2024 under the latest amendment. These exemptions are only applicable establishment licence holders either as importer or local manufacturer if the documentation as per the amendment is available.
Draft Amendments in the Drugs Rules 1976 and the Medical Device Rules, 2017 | 21 February 2023
The Drug Regulatory Authority of Pakistan (DRAP) has proposed to amend the current version of the Drugs (Licensing, Registering and Advertising) Rules, 1976 and the Medical Device Rules, 2017. These draft amendments are hereby notified, seeking comments from stakeholders.
Stakeholders can submit their comments within 14 (fourteen) days of the publication of this Notification using the prescribed format via email to [email protected], or can be posted at the mailing address, Additional Director, Division of Legal Affairs, Drug Regulatory Authority of Pakistan, 1st floor, TF Complex, 7th Mauve Area, G-9/4, Islamabad. Further information on comments submission can be accessed on this link.
Extension of grace period for medical device registration | February 2023
The Ministry of Health Kuwait has extended the grace period for the mandatory registration of medical devices to August 2023.
List of Updated ISO standards for December 2022
- ISO 11608-3:2022 Needle-based injection systems for medical use — Requirements and test methods — Part 3: Containers and integrated fluid paths
- ISO 21649:2023 Needle-free injection systems for medical use — Requirements and test methods
- ISO 5361:2023 Anaesthetic and respiratory equipment — Tracheal tubes and connectors
- IEC 80601-2- 59:2017/Amd 1:2023 Medical electrical equipment — Part 2-59: Particular requirements for the basic safety and essential performance of screening thermographs for human febrile temperature screening — Amendment 1
- ISO 8600-4:2023 Endoscopes — Medical endoscopes and endotherapy devices — Part 4: Determination of maximum width of insertion portion
- ISO 10943:2023 Ophthalmic instruments — Indirect ophthalmoscope
- ISO 31073:2022 Risk management — Vocabulary