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Medical Device Class IIa

Medical devices in the European Union are classified into four classes according to their risk profile. Classification as a Class IIa medical device corresponds to a comparatively lower risk profile within the EU risk classification system. It requires an external conformity assessment by a Notified Body. Classification is not merely a formal requirement; it is a verifiable indication that the product meets the applicable safety and performance requirements of the EU Medical Device Regulation (MDR).

Risk Classes under the EU MDR: Class I to III.

The EU Medical Device Regulation (EU) 2017/745 distinguishes between Classes I, IIa, IIb, and III. As the classification increases, the potential risk associated with the product generally increases, and the requirements for demonstrating safety and performance become correspondingly more stringent.

Class I: Low-risk products, e.g. simple wound dressings or walking aids. The manufacturer can generally self-declare conformity.
Class IIa: Medium-risk products. The involvement of a Notified Body in the conformity assessment procedure is mandatory.
Class IIb: Higher-risk products, e.g. ventilators or certain diagnostic imaging devices.
Class III: Products with the highest risk potential, e.g. heart valves or absorbable implants involving contact with the body.

Physician documenting a wound assessment, the clinical basis for MDR conformity assessment — Clinical documentation forms the basis of the technical documentation that the manufacturer must provide as part of the conformity assessment procedure under the MDR.

PLASMO®HEAL PRO is classified as a Class IIa medical device under Annex VIII of the EU MDR.

The Notified Body and its Identification Number.

A Notified Body is a conformity assessment body designated by the competent national authority and notified to the European Commission. Based on the manufacturer's technical documentation and clinical evaluation, it assesses whether the product meets the applicable requirements of the MDR. If the assessment is successful, the Notified Body issues the relevant certificate, enabling the manufacturer to affix the CE marking. Each Notified Body has a unique identification number, which is published in the EU's NANDO database and appears alongside the CE marking on certified products.

Nursing staff applying a sterile wound dressing, using a medical device certified as Class IIa under the EU MDR — The Class IIa certification provides the regulatory basis for the use of a medical device such as PLASMO®HEAL PRO in routine clinical practice.

PLASMO®HEAL PRO has been certified by TÜV SÜD as a Notified Body. In addition, WK-MedTec GmbH operates a quality management system in accordance with ISO 13485:2016, covering the development and distribution of medical devices for cold plasma applications.

Significance of the Class IIa Classification for Clinical Practice.

For users and healthcare decision-makers, the Class IIa classification of a medical device provides a reliable regulatory reference point. It indicates that an independent conformity assessment body has reviewed the safety- and performance-related documentation. As a certified medical device, PLASMO®HEAL PRO meets the applicable requirements of the European Union Medical Device Regulation (EU MDR).