April 7, 2022 Regulatory Updates

Medical Devices – USA/Europe Regulatory Updates Roundup, Mar 2022


SIQ Ljubljana became a notified body under the Decree on Medical Devices

Following the successful completion of the appointment and notification procedure under the Medical Devices Regulation (EU) 2017/745 (MDR Regulation), SIQ Ljubljana became a notified body for medical devices on 31 March 2022 and was entered into the European Commission’s NANDO database. It has thus become one of the 28 notified bodies under the new MDR regulation.
The scope of appointment of SIQ Ljubljana includes a wide range of groups of medical devices (active, inactive, devices containing software, sterile), special knowledge and technologies of medical devices.

Protective masks declared as personal protective equipment

Protective masks declared as personal protective equipment must comply with the Personal Protective Equipment Regulation:

In the process of determining the conformity of protective equipment, the equipment is divided into 3 categories, where III is the most stringent. Category III includes hazards that can have very serious consequences, such as death or permanent damage to health in relation to (among the listed) substances and mixtures that are hazardous to health.
Due to the assigned Category III , masks for sale in the EU must be verified and certified by a Notified Body.

Guidance update – MDCG 2019-9 – Rev.1 – Summary of safety and clinical performance

The main purpose of this document is to provide guidance on the presentation, content and validation of the SSCP (Summary of safety and clinical performance). The SSCP is intended to provide public access to an updated summary of clinical data and other information about the safety and clinical performance of the medical device.


Certain Ophthalmic Products: Policy Regarding Compliance With 21 CFR Part 4 Guidance for Industry

This guidance is intended to provide information to applicants and manufacturers regarding compliance with the requirements in part 4 (21 CFR part 4) for ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers. This guidance applies to products with pending applications, approved products, and products marketed pursuant to section 505G of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355h) without an approved application under section 505 of the FD&C Act (21 U.S.C. 355).

21 CFR Part 822:Medical Devices; Technical Amendments

The Food and Drug Administration is amending its medical device regulations to update mailing address information and to reduce the number of copies of certain documents that need to be submitted to FDA. The rule does not impose any new regulatory requirements on affected parties. This action is editorial in nature and is intended to improve the accuracy of the Agency’s regulations, and to remove a submission requirement that is no longer necessary.


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