June 17, 2020 Regulatory Updates

Medical Devices – Regulatory Updates – June Volume 2

1.MDCG issues guidance on transitioning devices with ancillary substances to MDR

The European Commission’s Medical Device Coordination Group (MDCG) issued guidance explaining the process for transitioning CE certificates for devices containing an ancillary substance that could be considered a medicinal product or those manufactured using animal tissues under the Medical Devices Regulation (MDR).
The document also explains some of the differences in requirements and consultations from previous legislation.

2.European Commission updates on MDR, IVDR implementing measures rolling plan

The European Commission this week updated its “rolling plan” for adopting implementing acts and other measures ahead of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

The update follows the move to delay the implementation of MDR by one year due to the coronavirus disease (COVID-19) pandemic and the decision to delay Eudamed’s rollout by two years last December.

Implementing acts and other activities

The rolling plan lists several upcoming implementing acts concerning

  • the reprocessing of single-use devices – is anticipated in Q3 2020
  • specifications for devices without a medical purpose – expected to be adopted in Q4 2020
  • the designation of expert laboratories – expected in Q3 2020
  • designations and rules pertaining to EU reference laboratories for in vitro diagnostics (IVDs) – adoption in Q1 2021&expected in Q3 2020 respectively
  • Eudamed Live- that notice is expected to be published in 2022
  • common specifications for high risk (Class D) diagnostics – Q3 2020

3.Spain: AEMPS reports on the usual procedure for the importation of medical devices

According to the usual procedure, a series of requirements must be met to authorize the import. The products must have the CE marking, have followed the corresponding conformity assessment procedure and that the importer has a previous operating license.

However, the AEMPS, for justified reasons, may authorize the importation of medical devices that do not meet any of these requirements. In this sense, the Agency issues extraordinary import authorizations in exceptional situations, after evaluating the conditions in which the products are going to be imported, in order to guarantee safety in their use.

4.UK: Medical devices: software applications (apps)

MHRA issued Guidance on what a software application medical device is and how to comply with the legal requirements.

5.Belgium FAMHP: Web portal – updates to the “My company” and “My activities” applications

In anticipation of the European regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), the FAMHP has updated the “My company” and “My activities” applications in its web portal.

What are the main changes?

  • The addition of risk classes from Regulations (EU) 2017/745 and (EU) 2017/746.
  • Subject to the establishment of a legal basis, healthcare facilities will be able to register and report their “in-house” manufacturing and reprocessing of single-use medical devices activities.
  • Activities that were previously listed under a single table will now appear in two separate tables:
    • One table containing activities that will also be registered in the Eudamed European web portal in the future: manufacturing, authorised representative, importer and system/package producer activities.
    • One table containing activities that will also be registered in the Eudamed European web portal in the future: manufacturing, authorised representative, importer and system/package producer activities.

6.Slovenia: Safety notices for Medical devices

Safety notices for medical devices received by JAZMP from manufacturers or manufacturers’ representatives in April 2020 are available on the JAZMP website. Safety notices are available at the following link.

The manufacturer of the medical device or the manufacturer’s representative must inform both the JAZMP and the users of the medical device in writing of the safety corrective measures, and the manufacturer must ensure that all users are properly informed.

In addition to the safety notification, the manufacturer of medical devices or the manufacturer’s representative must also submit to the JAZMP a report on safety corrective measures in accordance with Article 15 of the Rules on Vigilance of Medical Devices (Official Gazette of the RS, No. 61/10).


7Federal Register: Medical Device User Fee Cover Sheet and Device Facility User Fee Cover Sheet

The Food and Drug Administration (FDA or 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 revision of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments revising the information collection by adding Form FDA 3601a, entitled “Device Facility User Fee Cover Sheet,” which is submitted along with registration and listing fee payments.

8.Evaluation of Automatic Class III Designation (De Novo) Summaries

The Food and Drug Administration Modernization Act of 1997 (FDAMA) added the De Novo classification option as an alternate pathway to classify novel medical devices that had automatically been placed in Class III after receiving a “not substantially equivalent” (NSE) determination in response to a premarket notification [510(k)] submission.

Australia (TGA)

9.Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG

Information for sponsors regarding the supply of COVID-19 tests, including advice for those sponsors new to therapeutic goods regulation in Australia.

India (CDSCO)

10.Latest Public notifications have been released



11.Extension of the validity period of registration certificate and license

It is hereby noticed that, after reassessing the prevailing situation in the country due to COVID 19pandemic, the National Medicines Regulatory Authority has decided to extend the validity of certificates of registration and import licenses pertaining to Medicines, Medical Devices, Borderline Products and Cosmetics up to 31st July 2020. The extension is applicable for certificates and licenses expiring after 30th of June 2019.
The decision was taken in order to minimize the movement of people. The decision would be reassessed again on or before 31st July 2020.
As such you are kindly requested to refrain from coming to NMRA premises except for an urgent matter.

12.Notification: A grace Period for submission deadline

Due to Covid 19 emergency, manufacturers/importers/distributors may not have been able to submit the dossiers/extensions before the submission deadline to NMRA. A grace period up to 30.06.2020 is hereby granted to submission deadlines that fall between 15.03.2020 and 03.06.2020. NMRA will not consider them as new dossiers for the respective products.

Malaysia (MDA)

13.Guidance Document on Medical Gas System-Requirements for Registration

New guidelines established, this guidance document specifies requirement for registration of medical gas system “placed in market” as defined in Medical Device Act 2012.

14 Guidance document on Distribution Records

This guidance document specifies the requirements on distribution records that are to be established and maintained for all medical devices. This document is applicable to establishments including exporters dealing with medical devices.

RUSSIA (Federal Service for Surveillance in Healthcare (Roszdravnadzor)

15.Guidelines for the examination of the quality, effectiveness and safety of medical device (in terms of software) for state registration within the national system

The Federal Service for Supervision in Healthcare announces the introduction of Methodological Recommendations on the procedure for examining the quality, effectiveness and safety of medical devices (in terms of software) for state registration within the national system (hereinafter referred to as the Methodical Recommendations), approved on 09.06.2020, instead document approved on 08.24.2018. An updated version of the Guidelines is posted in the section “Medical Products” → “Regulatory Documentation”.

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