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Medical Devices - Regulatory Updates - September Volume 2

Medical Devices - Regulatory Updates - September Volume 2

September 17, 2020 Regulatory Updates

EUROPE

1.

MHRA: Regulating medical devices from 1 January 2021

The UK has left the EU, and the transition period after Brexit comes to an end this year. Stakeholders need to get ready for new rules from 1 January 2021.

From 1 January 2021 the Medicines and Healthcare products Regulatory Agency (MHRA) will take on the responsibilities for the UK medical devices market that are currently undertaken through the EU system.

This guidance provides information on how the UK system will operate, including for:

  • Getting your device certified
  • Conformity marking your device
  • Registering your device with the  MHRA

Summary of key requirements for placing a device on the Great Britain market

  • CE marking will continue to be used and recognized until 30 June 2023
  • Certificates issued by European Economic Area (EEA)-based Notified Bodies will continue to be valid for the Great Britain market until 30 June 2023
  • A new route to market and product marking will be available for manufacturers wishing to place a device on the Great Britain market from 1 January 2021
  • From 1 January 2021, all medical devices and in vitro diagnostic medical devices (IVDs) placed on the UK market will need to be registered with the MHRA. There will be a grace period for registering:
    • 4 months for Class IIIs and Class IIb implantable, and all active implantable medical devices
    • 8 months for other Class IIb and all Class IIa devices
    • 12 months for Class I devices
  • The above 12-month grace period will not apply to manufacturers of Class I devices and general IVDs that are currently required to register with the MHRA.
  • If you are a manufacturer based outside the UK and wish to place a device on the UK market, you will need to establish a UK Responsible Person who will take responsibility for the product in the UK.

The proposals outlined in this guidance notice will take effect through legislative changes that will be introduced later in 2020. They are still therefore subject to parliamentary approval.

2.

RZPRO: Extension of the validity of registered activities

With regard to the multiplying cases where registered persons do not file a notice of extension of activity pursuant to Section 30, Paragraph 2 of the Medical Devices Act within the time limit, i.e., until the expiry of the registration, the Institute asks registered persons to verify the validity of the registered activities. In the event that the activity is not extended in due time, it is necessary to register with RZPRO anew and submit a declaration of the person and activities performed by the company, i.e., to submit the notification as a new person. If only some of the activities have not been extended, it is necessary to log in to RZPRO in the standard procedure and submit a report of activities in RZPRO in the module of persons by clicking on the "activity report" icon. It is possible to use Manual No. 1 available to submit a person's report. The procedure for submitting an extension of activity / person is described in Manual No. 8 available.

3.

ANMDMR: For the attention of Romanian medical device manufacturers / authorized representatives / importers

The responsibility to assign SRN to economic operators rests with NAMMD, as the competent authority. To this end, Article 31 (2) provides that, after verification and validation of the data entered into EUDAMED by an economic operator, the competent authority of a Member State must obtain an SRN from the actors' registration module and approve its release to the manufacturer, his authorized representative or the importer who so requested.

On 30 October 2019, the Commission published a report concluding that the full functionality of EUDAMED requires the full availability and operation of all six modules and confirmation by an audit. The information envisages the launch of a fully operational EUDAMED by May 2022. However, at its meeting on 12 March 2020, the MDCG agreed that each EUDAMED module could be made available gradually as soon as it is operational. The Commission has confirmed its readiness to launch the actor registration module from 1 December 2020. MDCG members strongly encourage the use of the actor registration module by all relevant actors in their territories, including the use of SRN by actors, as stipulated in MDR (for example, SRN indication ANMDMR on certificates).

ANMDMR has announced its intention to participate in the voluntary registration in EUDAMED, as soon as the actors' registration module will be functional.

US FDA

4.

FDA Reminds Users about the Importance of Following Instructions for the Cold-Therapy Mode of Water-Circulating Hot/Cold Therapy Devices

The FDA monitors reports of adverse events and other problems with medical devices and alerts the public when needed to ensure proper use of devices and protect the health and safety of patients and users. The FDA is issuing this safety communication to inform patients and health care providers about the importance of following the instructions for the cold-therapy mode of water-circulating hot/cold therapy devices. This information is timely as patients may be recovering from surgery or an injury at home during the COVID-19 pandemic.

5.

Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Exemption (IDE) Applications, Premarket Notifications (510(k)s), and De Novo requests for medical devices that come into direct contact or indirect contact with the human body in order to determine the potential for an unacceptable adverse biological response resulting from contact of the component materials of the device with the body. The purpose of this guidance is to provide further clarification and updated information on the use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" to support applications to FDA. This guidance replaces Office of Device Evaluation (ODE) Blue Book Memorandum #G95-1 (1995), entitled “Use of International Standard ISO-10993, ‘Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing.’” This guidance document also incorporates several new considerations, including the use of risk-based approaches to determine if biocompatibility testing is needed, chemical assessment recommendations, and recommendations for biocompatibility test article preparation for devices with submicron or nanotechnology components and for devices made from in situ polymerizing and/or absorbable materials, which were not previously discussed in G95-1.

6.

FDA planning to harmonize adverse event reporting with eMDR updates

A new element indicating the Exemption Number associated with the MDR (if any) will be added to eMDR and eSubmitter, so that submitters will not need to report this information in Section H10 (Additional Manufacturer Narrative) with precise text formatting. The FDA expects submitters to cease reporting exemption numbers in H10, and instead use this new Exemption Number field, on or before February 28, 2021.

7.

Post-market review of face masks

Due to a rapid increase in demand for the manufacturing, importation and sale of face masks, there has been an increase in medical device inclusions in the ARTG, with many manufactured and imported from overseas.

Concerns have been raised about the quality and effectiveness of some products, particularly face masks, including that they:

  • are included in the ARTG but do not meet the legislative requirements for medical devices; or
  • may not, or do not, perform as intended (including the face-fit of respirators, especially those with ear-loops, and fraudulent or counterfeit products.

The TGA post-market review of face masks will validate if the devices included in the ARTG through the Class I inclusion process meet all the regulatory requirements and perform as intended.

India (DGFT)

8.

Notice regarding classification of non-notified medical devices

In accordance to MDR-2017 Chapter II, Rule 4 (3) the central licensing Authority needs to classify such medical devices as per risk based approach. In order facilitate the process to classify all such medical device, the devices are divided into 24 categories and examined as per the classification followed internationally and first schedule of MDR-2017.

All concerned associations/ stakeholder are requested to forward their comments at e-mail ID This email address is being protected from spambots. You need JavaScript enabled to view it. within 30 days from the date of issue.

9.

Online Application for Free Sale certificate Market standing certificate and Non-conviction certificate of Notified Medical Devices

In Order to streamline the regulatory submission procedure, the submission of application for issuance of Free sale certificate, Market standing certificate and Non—convention certificate of notified Medial devices is now functional an online system of Medical Devices portal (https://cdscomdonline.gov.in). The applicants seeking for such certificates may now apply through online portal as per the checklist.

The offline submission (hard copy) for such applications will not be accepted after 30-Sep-2020.

Malaysia (MDA)

10.

Conformity Assessment Body (CAB) - Requirements for Registration

This Guidance Document specifies the requirements for registration of CAB with the Authority as prescribed in Fourth Schedule of MDR 2012 to conduct conformity assessment as prescribed in Third Schedule of MDR 2012 as well as Conformity Assessment by way of Verification described in Circular Letter of the Medical Device Authority No. 2 Year 2014.