February 18, 2021 Regulatory Updates
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Medical Devices – Regulatory Updates – February Volume 2

EUROPE

1. Guidance on applying human factors to medical devices

MHRA has published guidance on the importance of applying human factors to medical devices, so they are designed and optimised to minimise patient and user safety risks. This guidance reflects mainly the changes to the regulation of medical devices in the UK as a result of the end of the transition period with the EU.

This guidance is primarily aimed at manufacturers of all device classes and developers of medical devices and drug-device combination products, and UK Approved Bodies responsible for assuring the quality of those devices.

It applies to the design of future products and changes in user interfaces of existing products, rather than those already on the market.

The guidance clarifies that usability engineering is an iterative process, involving design, testing and validation of design stages; it also requires attention to the post-market phase, since evidence may come to light while a device is being used in clinical practice that the design requires further improvement.

A usability engineering process can, and should, be applied by device manufacturers in the identification, assessment and mitigation of potential patient and user safety risks; also in the analysis of incidents that have occurred, in order to identify learning and put into place corrective actions to improve device design.

2. European Commission explains management of legacy devices in Eudamed

This document contains the details of how Legacy Devices will be identified in EUDAMED and the way the different Unique Device Identifiers for the Legacy Devices will be generated/assigned.

In general, the Commission says that, “Legacy Devices are subject to the MDR or IVRD registration requirements with some exceptions such as the assignment of a Basic [universal device identification-device identifier] UDI-DI and a UDI-DI.”

However, legacy devices without a Basic UDI-DI or UDI-DI will still be required to have a Eudamed DI, which is equivalent to a Basic UDI-DI, and a Eudamed ID.

“Therefore, a Basic UDI-DI will never be applicable and never be assigned to a Legacy Device, only Eudamed DI. On the other hand, a UDI-DI can be used to identify a Legacy Device in Eudamed,” the document states.

3. Virtual manufacturing of medical devices

Guidance for manufacturers who don’t design or manufacture devices but place their names on the product. All virtual manufacturers must now hold the full technical documentation for any product they place on the market under their name.

What has changed?

Two new product markings, the UKCA mark (which is valid in Great Britain) and the CE UKNI marking (which is required in Northern Ireland where conformity assessment has been conducted by a UK Notified Body) have been introduced for certain goods, including medical devices, being placed on the UK market.

The MHRA can designate UK Approved Bodies to conduct assessments against the relevant requirements for the purpose of the UKCA mark. CE marking will continue to be recognised in Great Britain (England, Scotland, Wales) until 30 June 2023. From 1 July 2023, new devices placed on the Great Britain market will need to conform with UKCA marking requirements. Separate rules exist for Great Britain and Northern Ireland.

For further information, refer to guidance. The text in this document has been updated to reflect these changes.

4. Information for clinical trial sponsors

With effect from Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83 / EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223 / 2009 and repealing Council Directives 90/385 (hereinafter ” EU Regulation 2017/745″) The Department of Medical Devices informs about changes that will be reflected in the agenda of authorization of clinical trials of medical devices.

Impact of the transitional provision in Article 120 (11) of EU Regulation 2017/745

It follows from the above transitional provision that all clinical trials authorized by the Institute under existing legislation must be started before the date of application of EU Regulation 2017/745, i.e., no later than 25 May 2021.

The Department of Medical Devices further points out that a clinical trial may be initiated only after the Decision on Authorization to conduct a clinical trial has become final.

It is recommended to submit an application for a KZ permit according to the ZP Act no later than 28 February 2021 and an application to change the conditions of the clinical trial by 31 March 2021 so that the Institute is able to assess the submitted documentation and the clinical trial can be launched into force by EU Regulation 2017 / 745.

Submission of applications for KZ permits after the effective date of EU Regulation 217/745

Pursuant to the provisions of EU Regulation 2017/745, applications for authorization of a clinical trial are submitted through the European Medical Devices Database (hereinafter “EUDAMED”). Based on the opinion of the European Commission of 30 October 2019, the launch of EUDAMED requires the full functionality of all six modules. The above-mentioned launch of the EUDAMED database is estimated by the European Commission at May 2022. From the effective date of EU Regulation 217/745 until the full functionality of the clinical trials module in EUDAMED , applications for clinical trials under Articles 62, 74 (2) and 82 of the Regulation EU 2017/745 , applications for changes in clinical trials permitted under existing legislation and the reporting of serious adverse events occurring during clinical trials shall be used Register of medical devices established pursuant to the Act on Medical Devices, as amended before the date of entry into force of the new Act on Medical Devices.

From the effective date of EU Regulation 2017/745, applications for a clinical trial will be submitted and assessed in accordance with Articles 70 and 74 and Chapter II of Annex XV to EU Regulation 217/745. Substantial changes to the clinical trial will be submitted and assessed in accordance with Article 75 and Annex XV, Chapter II of EU Regulation 217/745, even in the case of trials permitted under the ZP Act. Similarly, adverse events will be reported in accordance with EU Regulation 2017/745. The deadlines for the assessment of applications will result from EU Regulation 2017/745 and the new law on medical devices.

Thailand (FDA)

5. Ministerial Regulations for permission Notification of details, registration and fees

(a)To submit an application for permission to the licensor with information Documents or evidence as follows:

  • Registration number of a production establishment or Imported medical equipment
  • a letter showing that the applicant is a person appointed or assigned to operate the business
  • From the juristic person in the event that the juristic person is the applicant
  • Documents showing the names and details of the medical device Labels and documents Medical equipment
  • Conclusion about the medical device And medical device production information or product owner details
  • Documents showing the principles of They are important to safety and performance.
  • Of medical devices and methods that demonstrate conformity
  • A summary of the verification and design validation documents.
  • Documents showing risk analysis
  • Documents showing methods for the destruction, destruction or elimination of the resulting waste.
  • Quality system certification
  • Certificate of purpose of use, indication of packaging, certificate of label And how to use the manufacturer or product owner
  • Certificate of conformity for products from the manufacturer or product owner
  • Certificate showing history of the medical device of the manufacturer or product owner.
  • A certificate showing the safety of the manufacturer or product owner.
  • Evidence of permission from the agency having duties and powers to supervise the medical device.
  • In foreign countries Certified by the Food and Drug Administration
  • Power of attorney from the product owner to represent in the case of submitting an import
  • Medical equipment

In case there is a document clarifying the list of registered medical devices that are grouped

Medical equipment to submit the said documents together with Also apply for the application under paragraph one Clause 3.

For updated fees details

https://www.fda.moph.go.th/sites/Medical/News/Forms/AllItems.aspx#

For other process details like the below as follows see the source link-

  • Requiring the applicant to report details of production or import of medical devices without reporting information.
  • Prescribing the applicant for permission to manufacture or import medical device without reporting information
  • Notification of the Ministry of Public Health Re: Medical device that manufacturers or importers must declare (No.2)
  • Notification of the Ministry of Education Re: group of medical devices that manufacturers or importers must get permission.
  • Notification of the Ministry of Education Re: group of medical devices or medical devices that manufacturers or importers must register.

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