EUROPEAN UNION
Implementation of Regulation (EU) 2023/1194 on transitional provisions for products without an intended medical purpose | 21 June 2023
The deadlines for Annex XVI products mentioned in Implementing Regulation (EU) 2022/2346 has been extended in the Implementing Regulation (EU) 2023/1194 of 20 June 2023. To find out more about the extended deadlines, click here.
Addendum to MDCG Position Paper on the application of Article 97 | 30 June 2023
The position paper MDCG 2022-18 was published to provide a uniform approach to the application of Article 97 of MDR 2017/745 on medical devices (MDR) in situations where a certificate issued under the Directives has expired or expires before issuance of the necessary certificate(s) in accordance with the MDR.
The use of Article 97 MDR in those situations was meant to be a temporary solution. The goal of the position paper MDCG 2022-18 was to avoid a disruption of supply of devices on the EU market needed for health systems and patients.
Cybersecurity and Privacy in AI – Medical imaging diagnosis | 07 June 2023
ENVISA has released a report on Cybersecurity and privacy in AI – Medical imaging diagnosis. This report allows better assessment of the reality that artificial intelligence brings its own set of threats, which consequently insists on the search for new security measures to counter them.
This guide also strongly emphasizes privacy issues in the same way as cybersecurity issues, privacy being one of the most important challenges facing society today.
Security and privacy are intimately related, but both equally important, and a balance must be made specific to each use. As a result, as seen in this report, efforts to optimize security and privacy can often come at the expense of system performance.
FRANCE
ANSM notification on affixing barcodes for medical devices FSNs | 12 June 2023
n order to facilitate the identification of the devices affected by a field safety corrective action, ANSM recommends that manufacturers specify the following elements, directly in the field safety notice (FSN or appendix or web link that can be consulted directly):
- Media allowing the automatic capture of data (one- or two-dimensional barcode) of the medical devices concerned, in particular those already having a UDI (unique device identification), for computerized inventory management.
- The types of end recipients in the distribution chain concerned, to the manufacturer’s knowledge: pharmacy, pharmacy for indoor use, medical biology analysis laboratory, city care structure, large and medium-sized supermarkets, home healthcare provider …
- The exhaustive list of references and batches or serial numbers targeted by the field safety corrective measure (unless all the batches are targeted).
FINLAND
Medical device distributors not required to submit device notifications until further notice | 06 June 2023
The Finnish Medicines Agency (Fimea) has temporarily waived the requirement for medical device distributors to submit device notifications in accordance with the Medical Devices Act. This decision aims to simplify the process and reduce the burden on distributors.
Fimea has introduced an electronic submission service for operator details, but it currently does not include device data. The suspension of device notifications seeks to balance regulatory compliance and practicality.
IRELAND
HPRA notification on new case management system for medical devices | 06 June 2023
HPRA will implement a new case management system for medical devices from 6th June, resulting in changes to communication methods regarding cases.
Please read the information below carefully to ensure this transition does not impact your correspondence with us relating to your case.
- Change of case reference number (CRN)
Previously, the HPRA market surveillance or vigilance case reference numbers were displayed as VXXXXX or MSXXXXX.
Case numbers will now be alphanumerical for example CRN00011X. HPRA will still be able to identify any closed or ongoing cases using the old reference numbers.
- Changes to email communications
New cases will be assigned a dedicated e-mail address for example Case [email protected].
This will enable sending of case-specific communications directly to the allocated team.
E-mail correspondence sent to manufacturers from the HPRA that is relevant to the case will come from this dedicated e-mail address.
Please consult with IT departments within the organisation to ensure that e-mails of this nature are not blocked.
Please note that vigilance reports should continue to be submitted through devicesafety@hpra.ie
ITALY
Clinical investigation on medical devices: four decrees published in Official Gazette | 16 June 2023
Two ministerial decrees were recently published in the Official Gazette on June 13, 2023, in relation to administrative procedures for clinical investigations of medical devices. The first decree focuses on applications for clinical investigation of devices that are either not CE marked or are CE marked but used outside their intended purpose.
The second decree pertains to communications regarding clinical investigations on CE-marked devices used within their intended purpose. These decrees are in accordance with legislative decree n. 137/2022, which aligns national legislation with regulation (EU) 2017/745.
Effective from July 13, 2023, the decrees share a similar structure and aim to:
- Identify the eligible entities to submit applications and communications for clinical investigations.
- Clarify the procedures for submitting requests and communications related to clinical investigations.
- Define the methods and timelines for obtaining the national-level opinion from an Ethics Committee.
- Establish the means for communicating the initiation of investigations.
Additionally, two other ministerial decrees were published in the Official Gazette on June 14, 2023. The first decree focuses on ensuring the independence, transparency, and impartiality of the parties involved in handling clinical investigation requests.
It aims to prevent conflicts of interest and undue influence, mandating specific declarations and requiring abstention in cases of conflicts of interest.
The decree also allows for the involvement of experts with scientific and professional qualifications from research institutions, healthcare providers, or universities to evaluate survey questions.
The second decree addresses the requirements of suitable facilities for conducting clinical investigations aimed at demonstrating medical device conformity. It establishes that the assessment of facility suitability will be based on declarations submitted by the facilities’ legal representatives.
Moreover, the decree permits remote testing of devices using digital technologies under specified conditions. Both decrees also implement provisions outlined in legislative decree n. 137/2022 (paragraphs 5 and 8 of article 16).
Initiation of SMEMDN project to update EMDN | 19 June 2023
TThe SMEMDN project, funded by the EU4Health 2022 Work Program, has officially begun. It aims to support and maintain the European Medical Device Nomenclature (EMDN) required by EU regulations for medical devices.
The EMDN is based on the Italian classification system, the National Classification of Medical Devices (CND), which was adopted by the European Commission in 2019.
The project will last for 36 months and involves the Italian Ministry of Health and the Friuli Venezia Giulia Region. Its main objectives are to assist the European Commission in updating the EMDN, facilitate communication with member states and stakeholders regarding the nomenclature, provide tools to support the use of the EMDN, and collaborate with the World Health Organization.
The project follows a participatory approach, involving international stakeholders in maintaining and improving the EMDN. It considers technological advancements and evolving markets for medical devices. The EMDN has been used for medical device registrations in the European database for medical devices since October 2021.
UNITED KINGDOM (UK)
Updated Guidance on Borderline Products | 20 June 2023
Certain products can be challenging to categorize as they may share similarities with medicines, such as medical devices, cosmetics, food supplements, or biocidal products. These products are referred to as borderline products until their classification is determined.
The MHRA plays a crucial role in assessing the nature of these products. It determines whether a product meets the criteria for classification as a medicinal product and provides guidance on its status. Additionally, the MHRA evaluates whether a product should be classified as a medical device or falls under a different category. The guidance was updated on 20th June 2023.
Software and AI as a Medical Device Change Programme | 14 June 2023
Software (and AI in particular) plays an increasingly prominent role in health systems, having a wide set of applications across health and social care. Many of these applications will be regulated as medical devices. It is increasingly important then that medical device regulation be fit for purpose, to ensure patients, public, and healthcare professionals are empowered with the best medical technology available.
This work programme will deliver bold change to provide a regulatory framework that provides a high degree of protection for patients and public, but also make sure that the UK is the home of responsible innovation for medical device software.
MHRA / HRA Coordinated Pathway | 20 June 2023
The MHRA and HRA have collaborated to establish a coordinated assessment pathway that simplifies the review process for clinical investigations with medical devices. This pathway enables parallel reviews by the MHRA and Research Ethics Committee (REC), ensuring efficient sharing of information and benefiting applicants
Regulating Medical Devices in UK | 20 June 2023
The UK medical device market is governed by the Medicines and Healthcare products Regulatory Agency (MHRA). 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.
Extended acceptance of CE marked medical devices on the Great Britain market | 01 July 2023
An extended timeframe for the acceptance of CE-marked medical devices on the British market is now implemented. This means that medical devices with the CE mark will be accepted on the British market after the current deadline of 30 June 2023.
As a result, CE marked medical devices may be placed on the Great Britain market to the following timelines:
- General medical devices (MDs) compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028
- In vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner expiry of the certificate or 30 June 2030, and
- General medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until 30 June 2030.
SWITZERLAND
Medicinal Products with a Medical Device Component | 13 June 2023
Combination products are medicinal products with a medical device component. In the case of non-separable combinations (“integral” and “copackaged”), the combination product is not subject to the Medical Devices Ordinance. However, the medical device component must meet the basic safety and performance requirements according to Annex I EU-MDR.
For combination products (“integral” and “co-packaged”) currently authorized in Switzerland whose medical device component documentation also includes EU conformity certificates (CE certificates) for medical devices, the regulations on the validity of certificates set out in the changes to the EU-MDR will also apply.
If a new certificate is issued in accordance with EU-MDR, a separate application for variation does not have to be submitted. These certificates can be submitted together with another quality variation as an editorial change. If no other quality variations are planned in the near future, these certificates can also be submitted as a B.IV.1.z, type IA variation.
However, if the variation or new issuance of a certificate is the result of a significant change to the medical device component which affects/may affect the design or intended purpose or the quality, efficacy or safety of the combination product under medicinal product legislation, a separate application for variation must be submitted.
UNITED STATES OF AMERICA (USA)
Guidance on Premarket submission for Device Software Functions | 10 April 2023
FDA has released a new guidance document on the Content of Premarket Submissions for Device Software Functions. This guidance document is intended to provide information regarding the recommended documentation for premarket submissions for FDA’s evaluation of the safety and effectiveness of device software functions, which are software functions that meet the definition of a device under section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
AUSTRALIA
New guidance published on manufacturer evidence for IVD medical devices | 20 June 2023
TGA no longer accepts ISO 13485 certificates to support applications for new In Vitro Diagnostic (IVD) medical devices, except if the manufacturer made a Declaration of Conformity under the EU IVD Directive before 26 May 2022.
IVD medical devices that are already approved for supply based on ISO 13485 certificates will need to transition to another form of acceptable manufacturer evidence once the certificate expires, to continue to supply in Australia.
This guidance helps sponsors identify the actions they must take to transition to new manufacturer evidence and ensure ongoing regulatory compliance.
SINGAPORE
HSA’s SRA status for in vitro diagnostic medical devices (IVD)| 16 June 2023
The Health Sciences Authority (HSA) has been recognized by the WHO as the Strict Regulatory Authority (SRA) for high-risk In Vitro Diagnostic Devices (IVD).
This recognition allows HSA-registered IVDs to undergo an abbreviated WHO prequalification assessment, facilitating rapid access to international markets. HSA’s SRA status reflects its commitment to maintaining quality standards and improving public health.
MALAYSIA
Transition period for the use of electronic medical device certificates | 22 May 2023
The Medical Device Authority (MDA) will implement the use of electronic medical device registration certificates starting May 2, 2023 . The establishment can download the medical device registration certificate from the [email protected]+ system once the application is complete (status complete ) and the registration fee has been paid.
The use of electronic medical device registration certificates will be fully implemented from 1 January 2024 and no more physical medical device registration certificates will be issued by MDA.
BRAZIL
Anvisa publishes new medical device import manual | 22 June 2023
The new Manual for Importing Medical Devices is available on Anvisa’s portal . The document aims to guide importers on the rules for submission and procedures for analyzing import processes .
The subjects are organized into topics , which help consultation on the regularization of companies and products, procedural instruction and analysis and inspection procedures . The specific legislation and situations applicable to each topic are also indicated.
This publication is not intended to replace the guidelines on petitioning for the import process already published by the Agency or the manual available on the Siscomex Portal . The idea is to complement this information on specific aspects of consent to import medical devices in the context of Anvisa.
Users will be able to evaluate requests for medical devices | 20 June 2023
Those who use the medical device application service will be able to evaluate the process with Anvisa. The implementation of the evaluation will start from this Wednesday ( 21/6). The functionality is being gradually expanded to all requests made through the Solicita system , with the sanitizing area being the pioneer in implementing the service.
At the end of each request process, a link is provided for the user to send their opinion about the service request in the Request. The purpose of the assessment is to improve the provision of services offered by the Agency .
Another improvement that will be implemented is the categorization of services, to facilitate the location of the desired subjects, in addition to the other filters already available. The system will display only the subjects available for the selected process, reducing the possibility of errors in the petitions.
In addition, it will be possible to consult which service is associated with each subject and which other services are related (list of parent and child services) in the consultation tool available at https://consultas.anvisa.gov.br/#/consultadeassuntos/.
If the user identifies any lack of subject or service, he is requested to contact the appropriate area and describe the problem.
COSMETICS
EUROPEAN UNION
EU Proposes Amendments to Use Restrictions on D4, D5, D6 in Cosmetics | 27 June 2023
On June 22, 2023, the EU introduced new amendments to Annex XVII to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) through a draft regulation notified to WTO.
This draft proposes to further restrict the use of Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5), and Dodecamethylcyclohexasiloxane (D6) in cosmetics as well as other consumer and professional products. It is currently open for comment until August 21, 2023.
EU to Implement a Union-wide Ban on PFHxA in Cosmetics | 21 June 2023
On June 19, 2023, the EU notified WTO of a draft regulation aiming at amending the Annex XVII to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
This draft proposes to prohibit the use of Undecafluorohexanoic Acid (PFHxA), its salts, and related substances in various applications, including cosmetics. It is currently open for comment until August 18, 2023.
EU to Adopt Changes to Use Requirements for cosmetic ingredients | 14 June 2023
The EU introduced 11 changes to the ingredient lists in Cosmetics Regulation, including:
1) Adding one prohibited ingredient, and eight restricted ingredients;
2) Amending the use requirements for two permitted preservatives.
On June 8, 2023, EU notified WTO of a draft regulation that aims at revising the ingredient lists in Regulation (EC) No 1223/2009 (Cosmetics Regulation). The draft proposes to prohibit and restrict the use of certain cosmetic ingredients respectively, following the opinions from the Scientific Committee on Consumer Safety (SCCS), and is open for comments until August 7, 2023.
CANADA
Canada Bans Cosmetic Animal Testing | 27 June 2023
On 27th June 2023 , the Honourable Jean-Yves Duclos, Minister of Health, announced that the Government of Canada has banned the cruel and unnecessary testing of cosmetic products on animals in Canada, representing a major step forward in supporting animal welfare by reducing our reliance on animal testing, while ensuring health and safety.
With the passing of Bill C-47, Budget Implementation Act, 2023, No. 1, the Food and Drugs Act (FDA) has been amended to ban cosmetic animal testing. The new legislative changes mean that in Canada, companies will no longer be allowed to test cosmetic products on animals or sell their cosmetics that rely on animal testing data to establish safety.
The practice of testing cosmetics on animals has significantly decreased worldwide and was rarely conducted in Canada. By implementing these changes, Canada is aligning with the global shift toward ethical cosmetic testing by joining other countries, including all European Union countries, Australia, the United Kingdom, and South Korea, that have already taken measures to prohibit cosmetic animal testing.
Beyond cosmetics, Health Canada is working with the international scientific and regulatory community to develop, validate and implement effective alternatives to animal testing.
This includes providing continued leadership and contributions to the work of various committees and organizations, such as the Organisation for Economic Co-operation and Development (OECD) and the International Cooperation on Alternative Test Methods (ICATM).
CHINA
China NIFDC Consults on Updates to Prohibited Ingredients and Toxicological Test Methods for Cosmetics | 14 June 2023
On June 12, 2023, China’s National Institutes for Food and Drug Control (NIFDC) initiated a public consultation on proposed updates to the Inventory of Prohibited Ingredients for Cosmetics, along with the introduction of test methods for cosmetic ingredients. Interested parties are invited to provide their feedback and suggestions until July 15, 2023, by submitting the Feedback Form via email to [email protected].
Additionally, the consultation highlights the introduction of seven draft test methods for the toxicological test of cosmetic ingredients, which are developed according to Organization for Economic Co-operation and Development (OECD) guidelines. Notably, the draft U937 Cell Line Activation Test is a new animal testing alternative specifically for skin sensitization. It complements the existing skin sensitization test method in the Safety and Technical Standards for Cosmetics 2015 and aligns with the global movement towards cruelty-free practices.
China NIFDC Clarifies Detailed Registration Requirements for Special Cosmetics and New Cosmetic Ingredients | 26 June 2023
On June 5, 2023, China National Institutes for Food and Drug Control (NIFDC) released nine guidelines pertaining to the registration of Chinese domestic and imported special cosmetics, as well as high-risk new cosmetic ingredients (NCIs). 1 These guidelines provide clear details and time limits for the first registration, registration change, registration renewal and registration cancellation applications, which are highly informative for enterprises seeking guidance.
The latest guidelines are titled as follows:
- Guidelines for the Approval of Registration of New Cosmetic Ingredients with High Risks
- Guidelines for the Approval of Registration Change of Chinese Domestic Special Cosmetics
- Guidelines for the Approval of Initial Registration of Chinese Domestic Special Cosmetics
- Guidelines for the Approval of Registration Renewal of Chinese Domestic Special Cosmetics
- Guidelines for the Approval of Registration Cancellation of Chinese Domestic Special Cosmetics (Cancellation upon Application)
- Guidelines for the Approval of Registration Change of Imported Special Cosmetics
- Guidelines for the Approval of Initial Registration of Imported Special Cosmetics
- Guidelines for the Approval of Registration Renewal of Imported Special Cosmetics
- Guidelines for the Approval of Registration Cancellation of Imported Special Cosmetics (Cancellation upon Application)
The main content of these guidelines include:
- Administrative licensing item name and code
- Sub-item name and code of administrative licensing
- Business items that need to be handled
- Competent authority
- The Guidelines’ establishment and implementation basis
- Executive agency
- Approval levels
- Types of administrative licensing items
- Licensing conditions
- Application documents
- Intermediary services
- Approval procedures
- Acceptance and approval time limit
- Fees
- Administrative license
INDIA
India Proposes Amendments to Cosmetics Rules 2020 | 05 June 2023
The proposed changes cover terminology modifications, the introduction of new rules, the relaxation of certain regulatory requirements, and various other adjustments.
On May 17, 2023, the Ministry of Health and Family Welfare of India initiated a public consultation on proposed amendments to the Cosmetics Rules 2020, with the goal of improving the regulation and quality control of cosmetics in India.
The consultation period lasts 45 days, during which stakeholders are encouraged to provide feedback and suggestions to the Ministry, either by mail (see Notes at the end of the article for detailed address) or by email to [email protected].
THAILAND
Thailand Cosmetics Regulation Update: Release of Prohibited ingredient list | 30 June 2023
Thailand has recently implemented changes in the cosmetics regulations, introducing a new list of prohibited ingredients and updating the requirements for permitted preservatives. The latest updates now align Thailand’s regulations with the latest ASEAN Cosmetic Directive revisions.
On June 22, 2023, the Ministry of Public Health of Thailand (MOPH) issued three notices through the 140th Government Gazette of 2023, detailing the regulatory revisions pertaining to prohibited ingredients and permitted preservatives in cosmetics.
These notices officially came into effect on June 23, with a transition period applying to some rules.
ISO STANDARDS
List of Updated ISO standards for June 2023
- BS EN ISO 19979:2023 Ophthalmic optics. Contact lenses. Hygienic management of multi-patient use trial contact lenses (ISO 19979:2018)
- BS EN IEC 61676:2023 Medical electrical equipment. Dosimetric instruments used for non-invasive measurement of X-ray tube voltage in diagnostic radiology.