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Regulatory Affairs Updates 04/21

Medical Devices - Guidelines and Regulations Worldwide


The Medical Device Coordination Group (MDCG) published another position paper in the final weeks of last year. It clarifies the assignment obligations of Unique Device Identifier (UDI) for manufacturers of spectacle lenses and ready readers as required by the Medical Device Regulation (EU) 2017/745. Do not forget: the MDR finally comes into force on May 26, 2021! If you are still wondering about the details of the proper assignment of the UDI on your optical product, the guidance can give you valuable advice.



Due to the ongoing pandemic, working practices in medical technology are changing. On-site audits are difficult to perform since several countries introduced travel bans and quarantine restrictions. Remote audits are often the only way for Notified Bodies to continue to operate. The European Commission sets out its views on the conduct of remote audits in the actual corona period in this commission notice.

The “failure of notified bodies to carry out on-site audits” shall be limited in duration and “identified and justified on a case-by-case basis”. These “extraordinary” measures shall be monitored by the individual member states.


In response to the community feedback to regulatory approaches to Artificial Intelligence/Machine Learning-based medical software the U.S. Food & Drug Administration has published a five-part Action Plan. It deals with Good Machine Learning Practice (GMLP), Patient-Centered Approach Incorporating Transparency to Users, Regulatory Science Methods Related to Algorithm Bias & Robustness and Real-World Performance (RWP).

The most noteworthy section is probably the announcement of a tailored regulatory framework for AI/ML-based SaMD. Main focus lies on the Predetermined Change Control Plan which already exists in draft status. The Agency intends to publish a draft guidance in 2021. Comments will be considered in the further editing of the plan.


The Australian Therapeutic Goods Administration recently published updated information on the regulation of Software as a Medical Device. This guidance deals with general questions when putting software or apps on the market and combines further information on definitions, QMS or Risk Management.

Due to newly installed regulations by the Australian Governor-General in Council the further implementation of reforms to improve the regulation of medical devices delays.

If you are a manufacturer or sponsor of personalized medical devices in Australia, you should be aware of the TGA’s new framework for regulating personalized medical devices. This new framework will come into effect on February 25, 2021. Maybe you can profit from the transition period, which allows to supply personalized medical devices until November 1, 2024. To access the transition period, a Notification Form must be submitted before August 25, 2021.


Until March 16, 2021, you can participate in the annual update of Medical Device Directorate’s List of Recognized Standards for Medical Devices in Canada. An already available Guidance Document containing the corresponding list is in draft status. The proposed changes as well as contact information can be found under the following link:


In order to help the industry and healthcare professionals comply with the current Medical Device Act (Act 737), the Medical Device Authority of Malaysia published a guidance document on general grouping of Medical Devices. It provides helpful information on the details of grouping as a system, family or set. This document is in draft status and open for comments and feedback.

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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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