February Newsletter: EU REGULATIONS

MDCG 2022-4 – Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR | 16 February 2022 (February Newsletter 2022)

Article 120(2) and 120(3) of the Medical Device Regulation (EU) 2017/745 (MDR) state[A1] s that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD), or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of application of the MDR and no later than 26 May 2024 under certain conditions.

The mentioned conditions require that the notified body that issued the certificate under the MDD or the AIMDD continues carrying out appropriate surveillance with respect to all the applicable requirements relating to the devices it has certified.

Therefore, it is important for manufacturers, notified bodies and national authorities to get clarity on activities to be part of the appropriate surveillance referred to in Article 120(3) of the MDR.

MDCG 2022-3 – Verification of manufactured class D IVDs by notified bodies | 15 February 2022 (February Newsletter 2022)

Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices [A2] (IVDR) establishes the requirements for notified bodies involved in the conformity assessment of applicable classes IVDs.

Manufacturers must demonstrate that the devices conform to relevant requirements based upon objective evidence and analysis.

This document aims to provide guidance to notified bodies to clarify their role and responsibilities in relation to samples of manufactured class D devices or batches of devices in accordance with Annexes IX and XI of the IVDR.

This guidance also describes best practices for notified bodies in performing conformity assessment procedures relating to the verification of manufactured class D IVDs. It also includes guidance on:

• relevant information to be included within the notified body’s procedures,
• the content of the required pre-agreed conditions and detailed arrangements between the notified body and the manufacturer,
• guidance on the frequency of samples of devices or batches of devices to be sent to the EURL.

Update – MDCG 2021-21 Rev.1 – Guidance on performance evaluation of SARS-CoV-2 In Vitro Diagnostic Medical Devices | 15 February 2022 (February Newsletter 2022)

The guidance document concerns performance evaluation of SARS-CoV-2 In Vitro Diagnostic Medical Devices (IVDs) in the context of conformity assessment under either Directive 98/79/EC or Regulation (EU) 2017/746.

It covers devices for detection or quantification of SARS-CoV-2 nucleic acid, antigens, and detection or quantification of antibodies against SARS-CoV-2. These devices are collectively referred to as SARS-CoV2 IVDs.

The guidance is addressed to all interested parties, including the manufacturers, as well as notified bodies and competent authorities, authorised representatives, other market operators, professional and patient associations.

The content of this guidance document is envisaged to form the basis for common specifications to be adopted according to Article 9 of Regulation (EU) 2017/746 in the coming months.

The content may be adapted to take account of changing circumstances and increasing scientific and technical knowledge, as the COVID-19 pandemic continues to evolve.

Joint implementation Plan on actions considered necessary to ensure the sound functioning of the new framework for medical devices under the IVDR | 07 February 2022 (February Newsletter 2022)

A new legislative framework on medical devices, comprising Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) was adopted by the Council and the European Parliament in April 2017.

This new framework sets high standards of quality and safety for medical devices and aims at ensuring the smooth functioning of the internal market. The MDR was envisaged to apply from 26 May 2020.

In contrast, the IVDR has a date of application of 26 May 2022. In March 2020, the Medical Device Coordination Group (MDCG), composed of experts appointed by Member States, endorsed a joint implementation plan on the implementation of the MDR.

The plan listed priority actions for the Member States and Commission services, to be monitored at the level of the MDCG. The MDR joint implementation plan recognised the need to carry out a similar exercise for the IVDR. The present document therefore proposes a draft joint implementation plan for the IVDR.

IRELAND

Guide to Classification of a Medical Device | 16 February 2022 (February Newsletter 2022)

This document is a guide for classifying medical devices covered by the European Directive 93/42/EEC, as amended and the related Irish regulation, S.I. No. 252 of 1994, (‘the Regulation’).

It outlines the process for classifying medical devices and explains how to seek clarification on classification of a medical device. This guide sets out, inter alia, the reasons for classification and the routes to correctly qualify or classify a product under the Medical Device Regulation 2017/745 (MDR).

AUSTRIA

Clinical investigations with medical devices | 04 February 2022 (February Newsletter 2022)

As of 28 January 2022,[A3]  a new fee regulation of the BASG was put into force. From this date new fees apply for:

• clinical investigations of medical devices according to Regulation (EU) 2017/745
• performance evaluation studies of in-vitro diagnostics according to Directive 98/79/EC and
• amendments of clinical investigations of medical devices according to Directives 90/385/EEC and 93/42/EEC.

The electronic registration form is mandatory for a proper initial application for clinical testing of a medical device or performance assessment of an in vitro diagnostic medical device.

The following situations could potentially block [A4] the processing of an initial application or amendment and will result in an immediate e-mail response to the applicant that the procedure cannot be further processed:

• Missing or corrupted BASG application form (PDF and XML[A5] )
• No final positive ethics vote available for the overall study
• Clinical investigation plan, investigator’s brochure or patient information(s) are missing or do not comply with the versions in the final ethics committee opinion

The applicant is then also granted a period of 10 days for correction or submission of documents. In justified cases an extension can be requested for up to 20 days.

ITALY

Expenses for promotional activities of medical devices | 24 February 2022 (February Newsletter 2022)

All companies that produce or market medical devices, must send the declaration relating to the total amount of expenditure incurred in the year 2021 to the Ministry of Health, for promotional activities by 30 April 2022.

Information about the declaration and payment is available here.

In Vitro Diagnostic Medical Devices Regulation (EU) 2022/112 | 03 February 2022 (February Newsletter 2022)

The Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022 amending Regulation (EU) 2017/746 in relation to the transitional provisions for certain medical-diagnostic devices has been published in the Official Journal of the European Union vitro and the deferred application of conditions concerning in-house manufactured devices.

With this document we are moving towards a progressive introduction of the Regulation (EU) 2017/746 relating to in vitro diagnostic medical devices.

Regulation (EU) 2022/112 does not modify the requirements of Regulation (EU) 2017/746 in substance, but modifies its transitional provisions (Article 110).

No changes are foreseen for CE marked devices that do not require the intervention of a notified body or for “new” devices, i.e., those which have neither a certificate from a notified body nor a declaration of conformity pursuant to current directive 98/79 / EC.

For these types of devices, Regulation (EU) 2017/746 will apply from May 26, 2022, as envisaged. There is also a delay in application of the requirements for in-house devices.

Regulation (EU) 2017/746 introduced a set of common rules for such devices, which include requirements for the justification of their use and rules to ensure their safety and performance, such as an adequate quality management system.

CZECH REPUBLIC

Modification of the KZ module in RZPRO | 25 February 2022 (February Newsletter 2022)

The KZ module in Registry for Medical Devices (RZPRO) was modified so that in the case of submitting an application for permission to change KZRO and applications for the continuation of KZ, separate file marks were generated.

Therefore, the mentioned proceedings will no longer be conducted under the file number that was assigned to the KZ permit application. In the field of clinical trials, it is necessary to distinguish between individual procedures and therefore a separate file must be kept for each. A manual of the changes can be found here.

BELGIUM

Derogation for sponsors of non-commercial clinical trials to adapt packaging/labelling of an investigational medicinal product that is on the market | 24 February 2022 (February Newsletter 2022)

The European Regulation 536/2014 (Clinical Trial Regulation, CTR) came into force on 31 January 2022 and allows the packaging/labelling of investigational medicinal products already on the market not to be adapted for the clinical trial, except under special circumstances. 

LATVIA

Information about Clinical Trials Information System (CTIS) | 17 January 2022 (February Newsletter 2022)

Based on the new Clinical Trials Regulation, an informative presentation on Clinical Trials Information System (CTIS) has been prepared, and can be accessed here.

UNITED KINGDOM

Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland | 07 February 2022 (February Newsletter 2022)

The guidance explains about obtaining a Written Confirmation for each shipment of Active Substances manufactured in Great Britain (England, Wales and Scotland) that is exported to the EEA or Northern Ireland.

Importation of active substances into Great Britain (England, Wales and Scotland) without a Written Confirmation is accepted from the following list of countries:

• European Economic Area (EEA) countries
• USA
• Japan
• Republic of Korea
• Brazil
• Australia
• Israel
• Switzerland
• Northern Ireland

AUSTRALIA

Discussion paper on potential for mandatory reporting of medical device adverse events by healthcare facilities in Australia | 22 February 2022 (February Newsletter 2022)

The Australian Government is undertaking a significant program of reform to improve the safety, performance, and quality of medical devices in Australia and improve health outcomes for patients who require medical devices.

TGA released this Discussion Paper seeking feedback on potential changes to mandatory reporting of medical device adverse events – as part of the reform program.

The discussion paper can be found here.

Special Access Scheme (SAS)| 18 February 2022 (February Newsletter 2022)

The Special Access Scheme (SAS) allows certain health practitioners to access therapeutic goods (such as medicines, medical devices or biologicals) that are not included in the Australian Register of Therapeutic Goods (ARTG) for a single patient.

Therapeutic goods that are not included in the ARTG (and are not otherwise exempt from being in the ARTG) are described as ‘unapproved’. SAS applications and notifications can only be submitted by certain registered health practitioners.

Notifying or submitting an application: SAS Online System

Consultation on potential regulatory options for ‘export only’ biologicals| 15 February 2022 (February Newsletter 2022)

The Therapeutic Goods Administration (TGA) conducted a public consultation on potential options for the regulation of biologicals manufactured in Australia for export only (and not for supply in Australia).

Currently, biologicals included in the Australian Register of Therapeutic Goods (ARTG) can be exported, but they are not permitted to vary from the product supplied in Australia.

This means that ‘export only’ biologicals cannot have different indications, release specifications, or labels to the product approved by the TGA, even if the importing country has assessed and approved the product independently.

• Opening date: 15 November 2021
• Closing date: 22 December 2021

Importing COVID-19 Rapid Antigen Tests (RATs) | 11 February 2022 (February Newsletter 2022)

Only the approved supplier (sponsor) or their agent, as entered on the Australia Register of Therapeutic Goods (ARTG), can import rapid antigen tests (RATs) into Australia for commercial supply.

The RATs must be on the ARTG, under the name of the supplier, prior to importation. Any RATs imported for commercial supply must be the version manufactured and approved for the Australian market and not a parallel import.

Many therapeutic goods, including RATs, are available both in Australia and overseas.

When a legitimate version of an overseas product is imported with the goal of being marketed in the Australian market, this is known as parallel import. These goods may be genuine and made by the firm listed on the packaging, but they are not the version of the product that has been assessed for the Australian market and entered into the ARTG.

Parallel imports may or may not satisfy the same quality and safety criteria as Australian counterparts, and the TGA has not inspected them. Parallel imports are unapproved items that should not be imported for commercial purposes into Australia.

ACMD meeting statement, Meeting 65| 10 February 2022 (February Newsletter 2022)

The Therapeutic Goods Regulations of 1990 established the Advisory Council on Medical Devices (ACMD), which is a statutory advisory committee.

The TGA’s decision-making and other regulatory processes are aided by the committee’s independent expert input on specific scientific and technical matters.

Synthetic ligament applications for Achilles Tendon, Anterior Cruciate Ligament, and Rotator Cuff injuries, which were considered at ACMD 53, were withdrawn, and there were no other decisions made for these items.

At the 65th ACMD meeting, whether the benefits outweighed the risks for the devices and whether adequate evidence had been provided to demonstrate safety and performance through compliance with the Essential Principles, the committee considered Personalised Medical Devices and the following devices for discussion:

• an application for a bone and soft tissue filler that can be used with infections
• an application for a revision knee replacement system.

USA

About Manufacturer and User facility Device Experience (MAUDE) | 18 February 2022 (February Newsletter 2022)

Manufacturer and User Facility Device Experience (MAUDE) database represents reports of adverse events involving medical devices. The searchable database data contains the Medical Device Report [A6] [A7] (MDR) data of last 10 years.

MAUDE may not include reports made according to exemptions, variances, or alternative reporting requirements granted under 21 CFR 803.19.

The downloadable data files consist of voluntary reports since June 1993, user facility reports since 1991, distributor reports since 1993, and manufacturer reports since August 1996.

The public may search the database information on medical devices which may have malfunctioned or caused a death or serious injury. MAUDE data is current through the end of the previous month.

The FDA seeks to include all reports received prior to the update. However, the inclusion of some reports may be delayed due to technical [A8] or clerical difficulties.

Medical Device Reporting (MDR): How to Report Medical Device Problems | 18 February 2022

The FDA is extending the comment period  on the document published December 23, 2022 (86 FR 72969) by 30 days. Submit either electronic or written comments on the draft guidance by March 24, 2022.

On December 23, 2021, the FDA issued the draft guidance, Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.

This draft guidance will be open for public comments at www.Regulations.gov under docket number FDA-2021-D-0980. The FDA developed this draft guidance document to assist industry and FDA staff in assessing the credibility of Computational Modelling and Simulation (CM&S) used in medical device regulatory submissions.

This draft guidance, when finalized, is intended to help improve the consistency and transparency of the review of CM&S evidence, to increase confidence in the use of this evidence in regulatory submissions, and to facilitate improved interpretation of this evidence submitted in regulatory submissions reviewed by FDA staff. This draft guidance is not for implementation.

Center for Devices and Radiological Health Appeals Processes | 17 February 2022

The Food and Drug Administration (FDA / Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency.

Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice.

This notice solicits comments on information collection associated with certain Center for Devices and Radiological Health (CDRH) appeals processes.

Establishment Registration and Device Listing for Manufacturers and Importers of Devices | 07 February 2022

The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency.

Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice.

This notice solicits comments on information collection associated with establishment registration and device listing for manufacturers and importers of devices.

BRAZIL

ANVISA publishes standard on simplified analysis of clinical research | 23 February 2022

On 16 February 2022, in the Official Gazette (D.O.U), ANVISA published the Resolution of the Collegiate Board (RDC) 601/2022, which provides simplified analysis, on an exceptional and temporary basis, of clinical research petitions. 

The standard deals with a regulatory measure to cope with an emergency, as provided for in item I, art. 39 of Ordinance 162/2021. The measure seeks to quickly release petitions for medical research, provided that these petitions have been authorized by regulatory authorities of remarkable recognition.

ANVISA approves the registration of the first self-test for Covid-19 in Brazil | 17 February 2022

To grant registration, ANVISA analyses several technical requirements, including usability and risk management, which serve to adapt the product to use by lay people, ensuring greater security. Guidelines on usage of the product can be found here.

ANVISA prohibits collection kit for testing and diagnosis of Covid-19 without registration | 16 February 2022

ANVISA clarifies that these products can only be marketed in the country after registration.

Regulating remote inspections| 14 February 2022

ANVISA published a document with questions and answers on the regulation of remote inspections of imported goods and products subject to sanitary surveillance in ports and airports in the country by the modality of the Integrated System of Foreign Trade (SISCOMEX).

The objective is to allow the regulated sector to carry out inspections remotely on goods whose Import Licensing (IL) is under analysis by the Agency.

According to the rules of Resolution of the Collegiate Board (DRC) 597/2022 published in the Official Gazette (D.O.U.), the standard will enter into force on 2 March 2022. 

CANADA

Publication of third Interim Order respecting the importation and sale of medical devices (COVID-19): Notice to manufacturers, purchasers, and users | 21 February 2022

To accelerate access to certain medical equipment in Canada during the pandemic, Health Canada issued two interim rules on the importation and sale of medical devices for use in respect to COVID-19.

On March 18, 2020, the first interim order was issued, and on March 18, 2020, the second interim order was issued. As Interim Order No. 2 was set to expire on 1 March 2022, Health Canada has put in place a third interim order.

The first and second interim orders expedited the regulatory procedure for approving the importation or sale of medical devices used to diagnose, treat, mitigate, or prevent COVID-19 while ensuring that safety, efficacy, and quality requirements were satisfied.

The goal of Interim Order No. 3 is to keep the same flexibility that Interim Order No. 2 provided. Unless otherwise specified, all application conditions remain the same as in the second interim order. As a result, all active authorizations and expanded use indications under Interim Order No. 2 will be continued under Interim Order No. 3.

The manufacturer will not be obligated to take any action. Manufacturers of permitted devices under Interim Order No. 2 may continue to import and sell their products in Canada.

Any terms and conditions imposed on an interim order authorisation issued under Interim Order No. 2 remain in effect. Manufacturers must continue to operate under the same conditions as before. Interim Order No. 3 will remain in place for up to 1 year.

Regulations to allow exceptional importation of medical devices to address shortages as of 2 March 2022 | 16 February 2022

Amendments to the Medical Devices Regulations (MDR), published in Canada Gazette, Part II in September 2021, come into force on March 2, 2022, which will allow the exceptional importation and sale of medical devices to help address shortages in Canada.

Current provisions allowing the exceptional importation and sale of devices related to COVID-19 are set out under Interim Order No. 2 which will no longer be in effect after 1 March 2022.

The amendments to the MDR allow medical devices that would not otherwise meet Canada’s regulatory requirements to be imported and sold. However, these devices must meet the following conditions:

• the device is a substitute for one that is in shortage or at risk of being in shortage
• the device is authorized for sale in another jurisdiction
• the device is manufactured to quality standards comparable to those in the MDR
• the importer has a medical device establishment licence (MDEL)
• the importer informs Health Canada at least 5 business days before importing the device

SINGAPORE

Guidance on Medical Device Product Registration | 07 January 2022

The Health Sciences Authority (HSA) has amended the guidance document meant to assist applicants in the registration of medical devices under the Act and Regulations.

This guidance document describes the procedures and general requirements for the submission of an application for a new Product Registration for medical devices. The document can be found here.

Guidance on Grouping of Medical Devices for Product Registration (Revision 2) | 07 January 2022

This version of GN-12 guidance document applies to all medical device registration applications submitted to HSA. The grouping criteria described in the GN-12-1 and GN-12-2 shall be strictly adhered to in submitting your medical devices for registration.

This document is meant to provide guidance on the device specific criteria in determining whether certain models of specific medical devices can be included together and submitted in one product registration application. 

Grouping of medical devices for product registration facilitates the inclusion of multiple devices in one application.

BAHRAIN

Medical devices registration fast-track communication and delivery of services | 06 February 2022

The National Health Regulatory Authority (NHRA) announced a partnership with Adliya Business Center CO. W.L.L (ABC) as a private agency for instant communication and delivery of services for medical device registration, to help applicants who are having trouble preparing the required documents, and to speed up the registration process.

Applying through Adliya Business Center CO. W.L.L (ABC) is optional, as applicants can submit directly to NHRA.

Medical devices registration fast-track communication and delivery of services | 06 February 2022

In accordance with decision (48) of 2020 related to medical devices regulations, The National Health Regulatory Authority (NHRA) notified all the importers and shop owners, especially those who are selling medical and cosmetic lenses, about the necessity of verifying that the lenses are approved by NHRA.

Cases that will not be included in the medical device’s regulation | 06 February 2022

Based on the resolution no. (48) for the year of 2020, NHRA clarified that the following medical devices will not be subjected to registration:

1. Medical device imported for healthcare facilities for:
2. Emergency
3. A single time and not planned to be imported on a regular basis 
4. Medical devices imported for research and educational purposes
5. Personal imported medical devices
6. Custom-made medical devices or order for specific patient 
7. Samples for exhibition and conferences

INDIA

Regulation of sale of medical devices via registration of premises under MDR, 2017 | 09 February 2022

A draft of certain rules further to amend Medical Device Rules 2017, published after consultation with the Drugs Technical Advisory Board for information of all persons likely to be affected thereby, and notice is given that the said draft rules shall be taken into consideration on or after the expiry of a period of forty-five days from the date on which copies of the Gazette of India containing these draft rules are made available to public.

Objections and suggestions which may be received from any person within the period specified above will be considered by the Central Government. The draft rules can be accessed here, page 7.