Regulatory Affairs Updates | CW16| qtec-group

Regulatory Affairs Updates 16/20

Medical Devices - Guidelines and Regulations Worldwide

MDR – Breaking News

As per our last RA news update, the proposal for the MDR postponement is for vote today in the EU parliament.

In addition, the proposal was published with comments from Commission and Presidency. Those information provide more in depth understanding on the impact of the postponement. Here you can find the link to the updated proposal:



The TGA provided rules for the 3-D printing and exhorts that even though the fight against the pandemic, some components might meet the definition of a medical device and must be treated like that.
Depending on the class of the device, TGA provides a good overview what requirements and steps must be fulfilled to legally place a device on the market.

Depending on the class of the device, TGA provides a good overview what requirements and steps must be fulfilled to legally place a device on the market:

In addition, TGA grants an expedited way to market for domestic ventilator manufacturers if the following conditions are met:

  • be manufactured domestically in Australia;
  • be supplied to Australian healthcare facilities only; and
  • meet the specifications and testing requirements published in Ventilator for COVID-19 use in Australia.

United States

The FDA updates Question-and-Answer Appendix in Guidance on “Conduct of Clinical Trials of Medical Products During the COVID-19 Public Health Emergency”.
The guidance also includes new content on conducting remote clinician-reported outcome or performance outcome assessments or remote site monitoring.


The Malaysian authority has issued an overview for a clarification when Personal Protection Equipment (PPE) is meant to be a medical device as well and when not. For PPE that is a medical device as well, the approval of the authority is required prior to marketing of the devices.

Simultaneously the authority released a guidance called “SPECIAL ACCESS – REQUIREMENTS FOR VENTILATOR DURING EMERGENCY SITUATION” and clarifies within the procedure to be followed in order to make use of the special and expedited market access.

Further EU / MDCG Updates

The MDCG provided updates for two new guidances:
The guidance for “Interpretation of Article 54(2)b - Consultation Clinical Evaluation for Class III implantable and IIb active and medicine administering” clarifies the circumstances what the expression “device already marketed” means and states it cannot be intended to refer to a device already marketed uniquely under the new Regulation.

The second guidance titled “Temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions” relates to auditing in the times of the Corona pandemic.
As a specialty this guidance relates to the Medical Device Directives (MDD, IVDD, AIMDD) only, but will apply as well to MDR and IVDR should the availability of devices be affected by the virus. It states that as alternatives for current on-site audits measures like the following are foreseen:

  • Postponement of on-site surveillance audits
  • Replacement of on-site audits by remote audits using the most advanced available Information and Communication Technologies
  • Assessment of all relevant and required documents/records off-site
  • Taking into account existing recent results from MDSAP audits (or other appropriate audits)

However, initial certification or scope expansion audits are out of scope for the guidance.

China – standard updates

The NMPA has published an update of YY standards this month. The update introduces 12 standards for medical devices and IvD products.

  • YY 0336-2020 - Disposable sterile vaginal dilator
  • YY/T 0286.6-2020 - Dedicated infusion set Part 6: Disposable scale infusion set
  • YY/T 0681.18-2020 - Sterile medical device packaging test methods Part 18: Non-destructive inspection of packaging leaks by vacuum attenuation method
  • YY/T 0771.1-2020 - Medical devices of animal origin Part 1: Application of risk management
  • YY/T 0771.2-2020 - Medical devices of animal origin Part 2: Control of source, collection and disposal
  • YY/T 1477.5-2020 Standard test model for evaluating the performance of contact wound dressings. Part 5: In vitro model for evaluating hemostatic properties
  • YY/T 1667-2020 - Chlamydia pneumoniae IgG antibody detection kit (enzyme-linked immunosorbent assay)
  • YY/T 1676-2020 - Ultrasound Endoscope
  • YY/T 1684-2020 - Dentistry apex locator
  • YY/T 1695-2020 - Method for detecting amino acids in culture solution for human assisted reproductive technology
  • YY/T 1717-2020 - Nucleic acid extraction kit (magnetic bead method)
  • YY/T 1718-2020 - Medical Devices for Human Extracorporeal Reproductive Technology Embryo Transfer Catheter


Health Canada revised the guidance “How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device”.

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All updates compiled in one PDF file:

You can download all Regulatory Affairs Updates compiled for you as a PDF under the following link.

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