Manufacturer

General information

Manufacturer means any natural or legal person who is responsible for the design, manufacture, packaging and labelling of a medical device and places it on the market under his own name.

Borderline and Classification

The manufacturer defines the intended purpose and describes the principal mode of action of the medical device. On the basis of the intended purpose and the principal mode of action, the manufacturer must prove that the device fulfils the definition of a medical device in accordance with § 2 (1) MPG.

The classification of medical devices is carried out according to the rules in the respective directive:

Essential requirements

Safety and performance must be demonstrated on the basis of the essential requirements. The essential requirements are defined in Annex I of the relevant directives. The European Commission has published a directive-specific list of harmonised standards. Compliance with a harmonised standard gives presumption of conformity. The relationship between the harmonised standard and the essential requirements it satisfies can in principle be found in Annex Z of the harmonised standard. If the manufacturer does not (fully) comply with the harmonised standards, he must demonstrate that at least the level of protection defined in the standard is met.

Risk management

In accordance with the essential requirements, medical devices must be designed and manufactured in such a way that their use, does not compromise the clinical condition and safety of patients, the safety and health of users or, where appropriate, third parties. The solutions adopted by the manufacturer in the design and construction of the devices must be based on the principles of integrated safety, taking into account the generally recognised state of the art. In selecting the most appropriate solutions, the manufacturer shall apply the following principles, in the order given:

  1. eliminate or reduce risks as far as possible (inherently safe design and construction),
  2. where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated,
  3. inform users of the residual risks due to any shortcomings of the protection measures adopted.

Conformity assessment

As part of the conformity assessment, the manufacturer proves that the medical device is technically and clinically suitable and safe for the intended purpose. The manufacturer is responsible for carrying out the conformity assessment.

The conformity assessment procedure shall be chosen by the manufacturer depending on the class of the medical device, taking into account the requirements of the Conformity Assessment Regulation (or the applicable directive). For Class I medical devices, the manufacturer shall carry out the procedure laid down in Annex VII to Directive 93/42/EEC on his own responsibility; for in vitro diagnostic medical devices of the general class, the procedure laid down in Annex III to Directive 98/79/EC shall be carried out on his own responsibility. For all other medical devices, a notified body must be involved to carry out the apprpriate conformity assessment procedure based on the class of the medical device.

Clinical evaluation

For all medical devices (including Class I medical devices or general IVD), performance and safety must be demonstrated on the basis of clinical data. MEDDEV 2.7/1 rev.4 provides a guideline for the preparation of a clinical evaluation.

Reporting obligation

The manufacturer must establish and maintain a systematic procedure to evaluate experience with the medical device in the post-manufacturing phase. If the manufacturer becomes aware of a serious incident involving a medical device, he must report this immediately to the competent authority. The responsible authority for incidents in Austria is the BASG.

If the manufacturer determines that a medical device may present an unacceptable safety risk, appropriate risk reduction measures must be taken. Corrective action may be necessary both on the basis of incident reports and on the basis of other evidence. Every Field Safety Corrective Action (FSCA) must be reported.

 

Registration:

If the manufacturer is legally established in Austria, he shall register in the medical device register.

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