September Newsletter

September Newsletter

EU REGULATIONS

The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 03 September 2021

Regulations EU MDR 2017/745 on Medical Devices and EU IVDR 2017/746 on In Vitro Diagnostic Medical Devices contain important improvements among which stricter control for high-risk devices is implemented via a new pre-market scrutiny mechanism, reinforcement of the rules on clinical evidence and increased transparency. To this end, they require the establishment of scientific bodies, namely expert panels, expert laboratories, and EU Reference Laboratories (EURLs). Their roles, described in Article 106 of the MDR and Article 100 of the IVDR, are to provide the European Commission, Member States, notified bodies and manufactures with scientific and technical advice, contribute to guidance and other relevant documents, and to identify emerging issues of concern regarding medical devices and in vitro diagnostic medical devices.

Helsinki Procedure for borderline and classification under MDR & IVDR| September 2021

The document is an updated version of the system agreed at the Medical Device Competent Authorities Meeting in Helsinki in October 2002. The purpose of the system is:
• to allow consultation among competent authorities (CAs) on borderline and classification issues concerning medical devices
• to ensure that appropriate guidance is published in the Manual on Borderline & Classification for Medical Devices (hereafter referred to as the Manual)
The system was revised following the entry into application of the Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) by the Borderline & Classification Working Group (BCWG)1 of the Medical Devices Coordination Group (MDCG)
in 2021.

AUSTRIA

New Regulation on the Administrative Fee Tariff | 21 September 2021

A new fee regulation of The Federal Office for Safety in Health Care (BASG) was put into force from 1 August 2021 for clinical investigations of medical devices as per the EU Regulation 2017/745. The fee reduction applies to performance evaluation reviews and amendment requests for studies according to the Medical Devices Act, BGBl. I No. 46/2021 (tariff point XII.1.a-b) but doesn’t apply for initial and amendment applications (tariff points XII.2.a-g) for commercial studies. Tariffs for academic clinical investigations of medical devices according to Regulation (EU) 2017/745 are not reduced.

BELGIUM

New version of Belgian directive for management of clinical trials during coronavirus pandemic | 02 September 2021

The available new version of the national directive is the Addendum to the Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic. These new guidelines should help sponsors of clinical trials to manage:
• clinical trials for the prevention or treatment of COVID-19
• clinical trials underway in Belgium
This directive also provides answers to frequently asked questions and will be updated depending on how the pandemic further develops.

FINLAND

Piloting of the EU Regulation on Clinical Trials ends in Finland | 17 September 2021

Finnish Medicines Agency (FIMEA) and the National Committee on Medical Research Ethics (TUKIJA) started the piloting of the new clinical trials assessment process in accordance with the EU Regulation in November 2020. Now the project has reached the final stage. The project has reached the final stage and 27 September 2021 is the deadline for submission of applications regarding new clinical trials and substantial modifications in the pilot project.

SLOVENIA

Procedure for entering a test intended for self-testing in the central database of medicinal products (CBZ) | 14 September 2021

With a question on the procedure for the entry of rapid tests determining the presence of SARS-CoV-2 antigen in the Central Database of Medicinal Products (CBZ), Public Agency for Medicinal Products and Medical Devices (JAZMP) mandated submission of following documents for the registration:
• EC declaration of conformity showing that the test is for self-testing (risk class: IVD – self-testing, indicating the CE number of the certificate)
• CE certificate of notified body established in the EU (with reference to Directive 98/79/EC or Regulation (EU) 2017/746)
• Original package leaflet
• Instructions for use in Slovenian (Translation must be the same as the original instruction with all indications)
In accordance with the legislation in the field of medical devices, the business entity carrying out the marketing of the medical device or in vitro diagnostic medical device to the JAZMP must be properly registered.

MDCG guideline 2021-23 (Article 16 of EU regulation 2017/745) is installed by distributors, importers and notified bodies| 02 September 2021

The guidance intends to help notified bodies to implement requirements established by MDR and IVDR about certification activities to be carried out according to Article 16(4), attesting that the quality management system of the distributor or importer carrying out any of the activities mentioned in points (a) and (b) of Article 16(2) complies with the relevant requirements. It also addresses distributors and importers in respect to their quality management system to be certified by a notified body.

ITALY

Guidelines for the certification of quality systems of importers and distributors operating in parallel trade | 14 September 2021

The guide aims to aid notified bodies under Regulations (EU) 2017/745 and 2017/746 regarding the certification activities of the quality management system of importers and distributors, who operate as re-packagers and re-labelers (parallel traders) pursuant to Art. 16 (2) of the two Regulations. This guidance also addresses distributors and importers in respect to their quality management system to be certified by a notified body.

SPAIN

Extension of the deadline for adaptation of labelling and instructions for use of medical devices as a result of the EU-Switzerland MRA | 16 September 2021

The Spanish Agency of Medicines and Medical Devices AEMPS extends the deadline until 30 September 2022 for the adequacy of the labelling and instructions for use of medical devices because of the status of the EU-Switzerland Mutual Recognition Agreement (MRA) for medical devices.

The AEMPS publishes the Spanish translation of the guide for manufacturers of class I medical devices | 02 September 2021

The translation of the document “MDCG 2019-15 rev.1 – Guide for manufacturers of class I medical devices” aims to help Spanish manufacturers of such devices to comply with the provisions of Regulation 2017/745 on medical devices and apply to situations where an importer, distributor or any other legal person assumes the obligations mandatory for manufacturers.

CZECH REPUBLIC

Q&A for labelling | 24 September 2021

The Rules Governing Medicinal Products in the European Union Volume 4 guideline highlights the requirements for labelling of Investigational medicinal products regarding which questions and answers are published.

The Rules Governing Medicinal Products in the European Union Volume 4 guideline highlights the requirements for labelling of Investigational medicinal products regarding which questions and answers are published.

IRELAND

Public consultation on proposed clinical trial fees for 2022 | 10 September 2021

A new Clinical Trial Regulation (CTR) (Regulation No 536/2014) was adopted on 16 April 2014 and becomes applicable on 31 January 2022. The CTR is designed to benefit patients and medical research in Europe by streamlining the approval of clinical trials across the Member States. The document provides details of the fees intended to be charged for clinical trial applications under the Clinical Trial Regulation (CTR), and background information.

New Clinical Trial Fees

Clinical Trial Fees

Substantial Modifications

Substantial Modifications

SWITZERLAND

Update: Obligations for authorized representatives, importers and distributors | 27 September 2021

The following timelines apply to manufacturers or authorized representative established in an EU/EEA state:
• High-risk devices (Class III, IIb implantable and AIMD): 31 December 2021
• Moderate-risk devices (non-implantable Class IIb, Class IIa): 31 March 2022
• Low-risk devices (Class I): 31 July 2022
• Systems and procedure packs: 31 July 2022
EEA states are the member states of the EU, Iceland, Norway, and Liechtenstein but the timelines apply only to EU states, Norway and Iceland as Liechtenstein and Switzerland has the customs treaty between, due to which manufacturer in Liechtenstein is not obliged to designate an authorized representative in Switzerland.

All other foreign manufacturers are required to appoint a Swiss Authorized Representative with effect from 26 May 2021 and the labelling is linked to the designation of the Authorized Representative. These provisions apply both to MDD / AIMDD and MDR devices.

Unique identification no. in accordance with Art. 55 MedDO (CHRN – Swiss Single Registration Number) | 27 September 2021

The Swiss Single Registration Number (CHRN) is a unique identification number that Swissmedic assigns to Swiss manufacturers, authorized representatives, and importers upon request to unambiguously identify a manufacturer, authorized representative, or importer. It is necessary for economic operators domiciled in Switzerland to register once with Swissmedic within three months of placing their first product on the Swiss market. This rule also applies to persons who assemble systems and treatment units in accordance with Art. 11 MedDO. Questions and Answers are published as the updates on Swissmedic website.

BAHRAIN

Phase 2 of Permit to use of Medical Devices | 05 August 2021

NHRA is initiating the second phase of the national program of permit to use based on circular dated 19/3/2018 regarding the National Registry of Medical Devices and the Resolution No. (48) of 2020 on Medical Devices and Products’ Quality Control, article (8) which includes providing the quality assurance certificates for the previously listed devices on Phase one of the program which reached the total of 21,631 medical devices by sending the required documents to the medical device’s regulation team mail. This project would be completed by the end of 2025 where all previously approved and registered medical device details will be uploaded on NHRA website.

Tracing of Implantable medical devices | 28 June 2021

As per the National Health Regulatory Authority (NHRA), written policies and procedures should be implemented to:
• trace the implantable medical devices
• take the necessary corrective action if needed
• ensure the safety of patients from exposure to side or adverse effects which may be caused by the
devices
Following documents should be documented in a hardcopy or softcopy/software system format:
• Patient’s name
• CPR No.
• Contact No. / e-mail address
• Device Type
• Device Serial No.
• Manufacturer name and country of origin
• Bahrain authorized representative

Change of the appointment booking program | 15 June 2021

NHRA informs all the importers about the changing of appointment booking program for Medical devices regulations services from Appointy program to Microsoft Bookings as additional services are included. The appointment registration process will have an effective role in facilitating the procedures. Point to note is that pre-booked appointments were not affected.

Transforming the regulation of software and artificial intelligence as a medical device | 16 September 2021

Applications of AI to be regulated as medical devices can range from screening to diagnosis, to treatment, and to management of chronic conditions. MHRA has developed an extensive work program to inform regulatory changes including key reforms across the software as a medical device lifecycle, from qualification to classification, to requirements that apply pre- and post-market considering challenges and opportunities posed by AI as a medical device, ensuring these devices are appropriately evidenced and address issues of human interpretability and adaptivity. MHRA received a grant of £194,000 from the Regulatory Pioneers Fund for carrying out further research into how adaptive AI algorithms in medical devices change and how to regulate their decisions.

MHRA launches public consultation on future of medical device regulation | 16 September 2021 

10-week consultation launched by MHRA gives everyone the opportunity to draw on their own experiences and contribute to the improvement of the regulatory framework and therefore patient safety in the future. This consultation is comprehensive covering a broad range of regulatory issues from requirements for running clinical investigations, to how devices are assessed before being placed on the market through to importer and distributor obligations and post-market surveillance to transparency and the role of patients. The consultation is held here and it ends on 25 November 2021 at 11.45pm.

Long-term continual use of topical steroids linked to skin withdrawal side effects | 15 September 2021 

Topical corticosteroids are medicines applied directly to the skin to treat conditions such as eczema or psoriasis. Patients can experience topical steroid withdrawal reactions after using these products at least daily for long periods of time. A severe type of topical steroid withdrawal reaction can occur, which may also be known as red skin syndrome or topical steroid addiction for which the Medicines and Healthcare products Regulatory Agency (MHRA) advises anyone experiencing skin redness or burning sensations after they have stopped using these creams or ointments to seek advice from their health professional before using these products again.

Updated guidance on Managing clinical trials during Coronavirus (COVID-19) | 08 September 2021 

The guidance assists:
• those involved in clinical trials disrupted because of COVID-19
• those involved with ongoing studies, wishing to restart trials that have been paused or temporarily halted
• those wishing to start new studies

USA

Device Registration and Listing | 30 September 2021 

Owners or operators of establishments that are involved in the production and distribution of medical devices intended for use in the U.S. are required to register annually with the FDA. Congress has authorized FDA to collect an annual establishment registration fee for device establishments. The establishment registration fee is not eligible for a reduced small business fee. The annual registration user fee for fiscal year 2022 follows:

YEARFY2022
FEE$5,672

Electronic Submission Template for Medical Device 510(k) Submissions | 28 September 2021

This draft guidance document introduces submitters of premarket notification (510(k)) submissions to the Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER) to the current resources and associated content developed and made publicly available to support 510(k) electronic submissions to FDA.

Good Clinical Practice (GCP) Requirements for Data Submitted from Clinical Investigations for In Vitro Diagnostic (IVD) Device Premarket Submissions | 27 September 2021

The FDA has established human subject protection regulations addressing requirements for informed consent and Institutional Review Board (IRB) review that apply to all clinical investigations of devices involving human subjects, including deidentified human specimens.

Medical Device Material Safety Summaries: ECRI Reports | 22 September 2021

The U.S. Food and Drug Administration (FDA) partnered with Emergency Care Research Institute (ECRI), an independent non-profit organization, to perform a comprehensive literature search and systematic review to identify the current state of knowledge about medical device material performance after implantation. FDA and ECRI are publishing these safety summaries for materials that are commonly used in implantable medical devices and the effects of those materials on patients over time. Currently available safety summaries are of:
• Magnesium
• Polypropylene (often used in surgical mesh)
• Polyurethanes
• Siloxanes (often used in breast implants)

Unique Device Identification System (UDI System) | 16 September 2021 

The FDA established the unique device identification system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form, which will ultimately improve patient safety, modernize device post market surveillance, and facilitate medical device innovation.

BRAZIL

Import: pilot project makes migration to Single Portal of Foreign Trade | 20 September 2021

National Health Surveillance Agency (ANVISA) informed the regulated sector about the importation of advanced therapy products is now part of the petition pilot project through the application in the Module Licenses, Permits, Certificates and Other Documents (LPCO) import of the Single Portal of Foreign Trade. According to the publication, the Federal Revenue Service of Brazil (RFB) and the consenting agencies must migrate the import process to the Single Foreign Trade Portal, which should be used as a single window for users to make requests and hold on payments at all public agencies involved in the import process, such as ANVISA for products subject to sanitary surveillance. A step-by-step guide is available for companies in the regulated sector regarding the procedure.

ANVISA approves public consultation on import for scientific research | 15 September 2021

On 15 September 2021, the Collegiate Board of ANVISA approved the opening of a Public Consultation to update RDC 172/2017, which deals with the import of products and medicines for scientific or academic research. The objective is to improve sanitary control in the import of products used in scientific research with human beings and to curb the diversion of purpose for irregular consumption of these products.

Consolidation of standards did not change the merits of RDC 207/2018 | 02 September 2021

On 31 August 2021, ANVISA published the Board Resolution (RDC) 560/2021 standard for the organization of health surveillance actions related to the Operating Authorization, Licensing, Registration, Certification of Good Practices, Inspection, Inspection and Standardization, within the scope of the National Health Surveillance System – SNVS.

Standard updates requirements for producing male condoms | 01 September 2021

On 31 August 2021, the Resolution of the Collegiate Board (RDC) 554/2021 was published in the Official Gazette (D.O.U), which establishes the minimum requirements to produce male condoms of natural rubber latex. Topics covered are regarding the design and dimensions of the products, issues related to the expiration date of condoms, volumetric capacity, and pressure, as well as requirements for packaging and labeling, among other items. In addition to the requirements of RDC 554/2021, male natural rubber latex condoms must also meet compliance certification requirements under the Brazilian Conformity Assessment System (SBAC).

CANADA

Regulations amending certain regulations concerning drugs and medical devices (shortages) | 01 September 2021

On 11 August 2021, the Regulations Amending Certain Regulations Concerning Drugs and Medical Devices (Shortages) were made, amending the Food and Drug Regulations and Medical Devices Regulations, and were published in Canada Gazette, Part II on September 1st, 2021. These new regulations extend and modify certain measures already in place through 2 interim orders (IOs). They have been made to help track, prevent, and mitigate shortages of key health products in Canada, including drugs and medical devices.

AUSTRALIA

Export of therapeutic goods from Australia | 25 September 2021 

To export therapeutic goods from Australia, you must meet requirements set out in the therapeutic goods legislation, in addition to other Commonwealth and State or Territory legislation. Export regulation supports the development and manufacture of Australian therapeutic goods and ensures that goods leaving Australia meet appropriate safety and quality standards to support public health. Medical devices, including in-vitro diagnostic medical devices (IVDs) and Other Therapeutic Goods (OTGs) must be included in the Australian Register of Therapeutic Goods (ARTG) before you can legally export them, unless they are the subject of an exemption or exclusion. To facilitate export, the TGA issues export certification for medical devices that are included in the ARTG under section 58 of the Therapeutic Goods Act 1989. If certification is required by the importing country, the TGA can issue a Certificate of Free Sale or Export Certificate.

Reclassification of spinal implantable medical devices | 22 September 2021

The purpose of the provided guidance is to assist sponsors and manufacturers of spinal implantable medical devices to understand and comply with new regulatory requirements. From 25 November 2021, some spinal implantable medical devices will be required to be reclassified. The new regulatory requirements will also include:
• more detailed assessment of the manufacturer’s quality management systems and technical documentation related to each device
• conformity assessment documents demonstrating procedures appropriate for their classification
• a mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence

Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems | 22 September 2021

The provided guidance aims to assist sponsors of medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) with meeting their obligations and outlines transitional arrangements to help comply with new regulations. From 25
November 2021 medical devices intended to be used in direct contact with the heart, central circulatory system (CCS) or the central nervous system (CNS) will be required to meet regulatory requirements demonstrating the safety and performance for Class III medical devices.

The requirements include:
• more detailed assessment of the manufacturer’s quality management systems and technical documentation related to each device
• conformity assessment documents demonstrating procedures appropriate for a Class III device
• mandatory audit assessment by the TGA for device inclusion applications, including assessment of clinical evidence

Software for use with COVID-19 rapid antigen self-tests | 20 September 2021

The guidance includes information about the Therapeutic Goods Administration’s (TGA) requirements for software and apps designed for use with COVID-19 rapid antigen self-tests. Purpose of this document is to provide manufacturers and sponsors with guidance on the Therapeutic Goods Administration’s expectations concerning software or apps for use with COVID-19 rapid antigen self-tests that are intended to analyse and enable the interpretation of the test results. COVID-19 rapid antigen self-tests are tests that allow individuals to collect a specimen, conduct a test and interpret the results by themselves. These tests can be performed in the home, without the involvement of a health professional and are most accurate when used in a symptomatic person within the first few days of showing symptoms.

Conformity assessment certificates, changes to requirements for certain medical devices | 17 September 2021

On 23 July 2021 the Government repealed Regulation 4.1 and amended Regulation 5.3 of the Therapeutic Goods (Medical Devices) Regulations 2020. From 28 July 2021, medical devices that contain medicines or materials of animal, microbial, recombinant, or human origin and Class 4 in vitro diagnostic (IVD) medical devices no longer require mandatory TGA conformity assessment certification. Australia has some different regulatory requirements to Europe (e.g.: biologicals) and therefore, the amendment to Regulation 5.3 provides the TGA to audit applications to ensure the information provided meets the Australian regulatory requirements. This ensures that safety and performance is demonstrated prior to approving the device for supply in Australia.

Essential principles checklist (medical devices) | 15 September 2021 

Manufacturers are responsible to demonstrate compliance with the essential principles for their medical devices. Access to checklist

SINGAPORE

Cybersecurity vulnerabilities (BRAKTOOTH) affecting medical devices utilizing Bluetooth Classic | 01 September 2021

A recently discovered suite of cybersecurity vulnerabilities called “BrakTooth” are affecting various IOT devices, including medical devices that utilize specific Bluetooth Link Manager Protocols. If a medical device is affected by any of these vulnerabilities, it may allow an attacker in the radio range to trigger deadlocks, crashes or execute arbitrary code, which will lead to failure of critical device functions. To
address these vulnerabilities, security patches developed by the respective Bluetooth chip developers, will have to be applied to the affected devices. Industry Stakeholders are required to work with manufacturers to carry out the following:
• Identify the medical devices affected by the vulnerabilities
• Report to HSA at [email protected] once identified affected medical devices
• Perform a risk assessment of the vulnerabilities and the impact in the context of medical devices with reference to their intended use
• Develop risk mitigation plans, including interim work-around (e.g. segregation controls) to manage the risk until they can be patched
• Ensure that the necessary security patches are rolled out to all affected devices locally in a timely manner
• Communicate with the healthcare institutions and the end users of the medical devices proactively and recommend necessary actions to reduce the risk and potential harm to the patients and users.

RUSSIA

Information about the medical organization and employed medical workers in the relevant Federal Registers. | 01 September 2021

From 1 September 2021, the Decree of the Government of the Russian Federation dated 01.06.2021 No. 852 came into force, establishing licensing requirements for the implementation of medical activities. This decree includes new requirements for the license applicant to place in the Unified State Information System. in the field of health care information about a medical organization in the Federal Register of Medical Organizations and about medical workers in the Federal Register of Medical Workers.

INDIA

Guidance Document for Manufacturers / Importers for voluntary/ mandatory registration of Medical Devices | 21 September 2021

The document highlights list of details and documents required for registration of medical devices by the Manufacturers and Importers along with steps to be followed by the manufacturers/ importers for registration of non-notified medical devices.
• The registration of Class A, B, C & D devices has been kept voluntary for a period of 18 months with effect from 1 April 2020 i.e. till 30 September 2021
• Voluntary Registration of Class A & B devices shall be followed by mandatory registration for 12 months after 18 months of voluntary registration period is over i.e. up to 30 September 2022
• From 01 October 2022 Class A & B devices will fall under licensing regime.
• Voluntary Registration of Class C & D devices shall be followed by mandatory registration for 24 months after 18 months’ Voluntary registration period is over i.e. 01 October 2021 to 30 September 2023
• From 01 October 2023 Class C & D devices will fall under licensing regime

PAKISTAN

Conduct of clinical trials guidelines (v2.0) | 02 September 2021

The guideline, drawn in conformity with the legal requirements of the Bio-Study Rules 2017, Drug Act 1976 and DRAP Act, 2012 and the rules framed under, describes the requirements, procedure for submission, review, evaluation, and approval of applications for the conduct of clinical trial. It is required that all the therapeutic goods and health products used in Pakistan are registered with the Drug Regulatory Authority of Pakistan (DRAP) and any clinical trial using such registered or unregistered products must receive written approval (i.e. license for Clinical Trial Site & Clinical Studies) from DRAP, under the Bio-Study Rules 2017 for that purpose. The guidelines set out the procedures that should be followed by applicants who wish to conduct clinical trials in Pakistan and the steps that DRAP will take to review, evaluate, and permit the conduct of such trials.

INTERNATIONAL STANDARDS

BS EN ISO 13485:2016: 2021 Amendments| 09 September 2021

EN ISO 13485:2016+A11:2021, was published by the European standards bodies, CEN and CENELEC featuring new annexes ZA and ZB that link the requirements of the MDR and IVDR, respectively, to specific clauses of the standard.

IMDRF DOCUMENTS

Assessment and decision process for the recognition of conformity assessment body conducting medical device regulatory reviews | 24 June 2021

The document intends to:
• improve the efficiency and effectiveness of the review process for marketing of medical devices
• explain the assessment process and outcomes, including the method to “grade and manage”
nonconformities resulting from a recognizing Regulatory Authority’s assessment of a CAB
• document the decision process for recognizing a CAB or cessation of recognition


The document defines:
• the process and lifecycle for recognizing, maintaining, or ceasing recognition of a CAB
• the process of managing, grading, and closure of assessment nonconformities issued to a CAB
• the outcomes of an initial, surveillance, or re-recognition assessment of a CAB

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