EC Adds Six New Products to Borderline and Classification Manual

Regulatory NewsRegulatory News | 07 November 2018 |  By 

The European Commission (EC) added six new medical and nonmedical products to its manual on borderline and classification cases based on the regulatory framework for medical devices.
EC’s manual is intended to serve as a tool to help manufacturers achieve time and cost savings by providing regularly updated clarifications. These policy updates clarify whether a product would be considered a medical device consistent with the European Medical Device Vigilance System (MEDDEV).
Out of the six new products in manual Version 1.20, four are considered medical devices under the EU’s current regulations. The remaining two products—the “mattress covers against mites” as well as “lubricants intended for body massages and/or sexual intercourse”—fall outside of the EU’s regulations’ medical device definition, per EC’s borderline and classification manual.
New products in the manual that are considered by EU law to be medical devices include three products in software and mobile applications.
These products are identified in EC’s manual as a “product intended to facilitate conception and enable contraception based on basal body temperature,” the “product intended to facilitate conception based on basal body temperature” and the “stand-alone software application for conception and contraception purposes using data entered by the patient,” as identified by the product manufacturer. The remaining newly added product to EC’s updated manual that has been now categorized as a medical device is the “trial hip prosthesis heads or stems.”
The manual is updated at least once a year and the policy clarifications set forth are based on whether EU member states can reach consensus on the interpretation of the law, though how these interpretations may vary after the implementation of the EU’s new medical device and in vitro diagnostic regulations to be phased-in in 2020 and 2022, respectively, remains to be seen.


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Tags: EU MDR, Europe

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