March 18, 2021 Regulatory Updates
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Medical Devices – Regulatory Updates- March Volume 2

EUROPE

1. Announcement of the President of the Office of 1 March 2021 on the registration of business entities in the European database on medical devices Eudamed

In connection with the launched module for the registration of entrepreneurs in the European database on medical devices Eudamed, every entity with a place of residence or registered office in the territory of the Republic of Poland, which, in accordance with art. 31 sec. 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council or art. 28 sec. 1 of Regulation (EU) 2017/746 of the European Parliament and of the Council, submitted the required information for registration in the Eudamed system, should submit a letter to the President of the Office confirming the submission of the above-mentioned entry for a unique registration number.

The manufacturer and the authorized representative must also submit a declaration that the persons responsible for regulatory compliance listed in section 4 of the Eudamed database meet the requirements of Art. 15 of Regulation 2017/745 or Art. 15 of Regulation 2017/746.

Moreover, the authorized representative shall attach a copy of the document confirming the appointment by the manufacturer as an authorized representative. Pursuant to Art. 2 clause 32 of Regulation 2017/745 or art. 2 clause 25 of Regulation 2017/746, an authorized representative means a natural or legal person established in the Union who has received and received a written mandate from a manufacturer established outside the Union to act on behalf of the manufacturer in relation to specific tasks with regard to the manufacturer’s obligations under of this Regulation. Based on Article. 11 sec. 2 of Regulation 2017/745 or art. 11 sec. 2 of Regulation 2017/746, the appointment of an authorized representative by a non-EU manufacturer is valid only if accepted in writing by an authorized representative.

Pursuant to Art. 31 (2) of Regulation 2017/745 or Art. 28 sec. 1 of Regulation 2017/746, after verifying the entered data, the competent authority obtains a unique registration number (SRN) from the electronic system and issues it to the manufacturer, authorized representative or importer.

In connection with the above, please provide the originals or certified copies of the above-mentioned documents in writing or via the ePUAP platform to the address of the Electronic Mailbox: / URPLWMiPB / SkrytkaESP. The documents should be signed by a person authorized to represent the entity in accordance with the entry in the relevant register. In the case of certified copies, the authentication of the documents means that they are confirmed to be true to the original by a notary public or by an attorney-at-law, legal advisor, patent attorney or tax advisor or by an authorized employee of the authority. If a copy of the document has been made in the form of an electronic document, its compliance with the original is certified using a qualified electronic signature.

2. Newsletter on the new EU regulation (MDR) which enters into force on 26 May 2021

With this and future newsletters, the Danish Medicines Agency will equip the Danish players for the new EU regulation on medical devices.

In this newsletter you can read about the latest developments with MDR, the background for the new regulation, and then the Danish Medicines Agency has collected links to all relevant information channels where you can follow the implementation.

In future, the newsletters will therefore give you an overview of the new rules that come with the regulation so that you as an actor know what you have to deal with.

The first thing the Danish Medicines Agency will inform about is the new executive orders on medical devices, etc., which the Ministry of Health has sent out for consultation on 2 March. Read the draft on the Consultation Portal.

The Danish Medicines Agency is also in the process of updating 17 guidelines for medical devices and the draft of the first four guidelines has been sent for consultation on 5 March. You can find the draft guidelines on the Consultation Portal.

3. MDCG addresses custom devices under MDR

This Q&A is a high-level document aimed at addressing the most pertinent questions relating to custom-made devices falling under Regulation (EU) 2017/745 on medical devices (MDR). Further guidance on this subject may be elaborated by the MDCG, as appropriate.

In accordance with Recital 5 of the MDR, certain references to International Medical Device Regulatory Forum (IMDRF) guidance documents and terminology included therein have been taken into account under this Q&A. Specifically, the MDR regulatory status of adaptable medical devices and patient-matched medical devices (introduced by IMDRF PMD WG/N49 FINAL: 2018) is clarified in this Q&A.

One of the major issues addressed in the Q&A document has to do with the use of parts, components or materials specifically intended to be used in a CMD, adaptable device or patient-matched device and the implications of whether those parts, components or materials are CE-marked or placed on the market under MDR.

“The intended purpose of a medical device can be achieved either alone or in combination with other devices or products. Certain parts, components or materials may carry a medical intended purpose and can thus fulfill the definition of a medical device. By analogy, parts, components or materials of custom-made devices, adaptable medical devices or patient-matched devices may be CE-marked medical devices,” MDCG writes.

MDCG also clarifies that such “intermediate products” may be placed on the market on their own. “Instructions for use provided by the manufacturer of these CE marked devices should be followed when performing further preparatory processing, preparation, configuration, installation, assembly, adaptation or fitting in order to meet the needs of the user or patient prior to their use,” MDCG adds.

The document also clarifies some of the obligations of CMD manufacturers under MDR.

4. Guidance on harmonised administrative practices and alternative technical solutions until EUDAMED is fully functiona

This document provides guidance to Member States and other relevant parties on the application of certain MDR provisions during the absence of EUDAMED. To that end, this guidance intends to describe harmonised administrative practices and alternative technical solutions for the exchange of information until EUDAMED becomes fully functional.

“Until Eudamed is fully functional, the MDR stipulates that the corresponding provisions of Directives 90/385/EEC and 93/42/EEC shall continue to apply for the purpose of meeting the obligations laid down in the provisions of Article 123(3)(d) regarding the exchange of information,” MDCG writes. Article 123(3)(e) also specifies that requirements obligations and requirements set out in Articles 29(4) and Article 56(5) of MDR apply 24 months after the notice.

Accordingly, the MDCG guidance breaks down the Eudamed-related provisions of MDR and provides alternative solutions to fulfill the requirements for submitting or exchanging information.

“The proposed practices and solutions aim to enable member states and other relevant parties to meet their obligations under the MDR effectively while minimising any potential additional burden on the parties concerned. This guidance addresses in particular cases where the exchange of information would be difficult, or even not possible, to achieve based on the corresponding provisions of Directives 90/385/EEC and 93/42/EEC,” MDCG writes.
Specific guidance is provided for administrative practices and alternative technical solutions for Eudamed-related obligations and requirements under MDR Articles 29, 31-33, 40, 42, 43, 46, 53-56, 70, 73-78, 80, 86- 89, 90, 93, 95, 97-99 and 120.

5. Special requirements in Northern Ireland

On March 5, 2021, the MHRA published a new version of their guidance document for placing devices on the Northern Ireland market. Where previous versions of the document were not clear about the role of the importer, there is now clear reference to the Medical Devices Regulation (MDR) and In-vitro Diagnostic Medical Devices Regulation (IVDR): the importer must comply with Article 13, distributors must comply with Article 14 and manufacturers or their AR must comply with Article 15 about the Person Responsible for Regulatory Compliance. These requirements will apply from May 26, 2021 for medical devices and from May 26, 2022 for IVD’s. This implies that EU law will apply to certain UK citizens, who will be subjected to ruling by a non-UK judge. At the same time those citizens will also be subjected to UK law. This dual position is likely to have an impact on the situation in Northern Ireland.

CHINA (CMDE)

6. Notice on matters related to the registration of medical device master files (No. 2 of 2021)

The registration application is further simplified for convenience Medical device manufacturers select raw materials and key components to improve the quality of medical device review and approval. On March 5, 2021, the State Food and Drug Administration issued the “Announcement on the Registration of Medical Device Master Files” (State Drug Administration 2021). In order to facilitate the owner of the master file to handle the registration of the master file, the relevant matters are hereby notified as follows:

  • About the application for the digital certification (CA) certificate of the electronic application of medical device registration information system,
  • Regarding the registration

SINGAPORE (HSA)

7. Consultation on Medical Devices Product Classification Guide

The Medical Devices Branch (MDB) has published a draft document “Medical Devices Product Classification Guide” for comments. This document is intended to assist our stakeholders in determining whether a product is classified as a medical device. We would like to invite our stakeholders to provide feedback on this document:

Medical Devices Product Classification Guide

The Consultation period for this document is from 15 March 2021 to 15 April 2021. Please email your feedback using the prescribed feedback form to HSA_MD_INFO@hsa.gov.sg by 15 April 2021. Please indicate “Medical Devices Product Classification Guide” in the email subject header.

AUSTRALIA (TGA)

8. Custom made medical devices: Information for sponsors, health professionals & manufacturers regulations

From 25 February 2021, a new framework for regulating personalized medical devices has commence. The framework includes a new definition for custom-made medical devices. The impact of the new definition is the majority of devices currently supplied under the exemption for custom-made medical devices will no longer meet the definition of a custom-made medical devices and will need to be included in the Australian Register of Therapeutic Goods (ARTG).

Transition arrangements are available to allow continued supply of your devices until 1 November 2024. To access the transition period, you must submit the following form before 25 August 2021: NOTIFICATION FORM: Transition arrangements for custom-made medical devices.
More information about the new framework, including information about the changes to how custom-made medical devices are regulated, is available on TGA website: Personalized medical devices (including 3D-printed devices).

9. IMDRF consultation: Assessment and Decision Process for the Recognition of a Conformity Assessment Body Conducting Medical Device Regulatory Reviews

The International Medical Device Regulators Forum (IMDRF) working group on Good Regulatory Review Practices seeks to develop guidance that establishes good regulatory review practices for Regulatory Authorities and/or Conformity Assessment Bodies (CABs), and to promote global harmonization in the premarket review processes.

This draft IMDRF document is part of a series that is under development that will help to establish a common set of requirements to be used by Regulatory Authorities for the recognition and monitoring of entities that perform regulatory reviews of medical devices, including IVDs medical devices.

The IMDRF working group is seeking comments from interested parties on the proposed guidance document, which outlines the process used to evaluate CAB performance and the possible outcomes if performance issues are identified.

The TGA, together with all other working group members, invite interested parties to comment on the document.

KAZAKHSTAN (NDDA)

10. On the portals of drugs and medical devices, the standard contract for the examination of medicines and medical devices has been changed

RSE on REM “National Center for Expertise of Medicines and Medical Devices” (hereinafter – NTsELS and MI) informs you that, according to the order of the Minister of Health of the Republic of Kazakhstan No. (the order of the Ministry of Health of the Republic of Kazakhstan No. 736 dated 11/18/2009 was previously in force) on the portals of drugs and medical devices the standard contract for the examination of medicines and medical devices has been changed.

At the same time, according to the draft agreements that are in the work of the NCELS and MI, contracts will be concluded taking into account the new rules.

11. Reference pricing for drugs and medical devices

In order to conclude an agreement on the reference pricing of drugs and medical devices, you must write to the e-mail address dogovor@dari.kz .
After the conclusion and registration of the agreement should send a request for payment (request for account) in the form (a form of drug , form MI ) to the email address support@dari.kz .

Applications must be filled in completely and correctly with the obligatory indication of the cost, including VAT.

After sending an application for payment (application for an account) to support@dari.kz, you will be sent a registration number. Accordingly, your application has been transferred to the accounting department to form an invoice for payment. The invoice will be sent to your email address specified in the application.

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