Medical devices are currently subject to the requirements of the 93/42/EEC Directive and the Medical Devices Act in Germany. As of May 26, 2021, medical devices will be subject to the requirements of Regulation (EU) 2017/745(Medical Devices Regulation, MDR), which replaces Directive 93/42/EEC.
Medical devices are directly affected by the obligation to affix a CE marking and to undergo the CE conformity assessment procedure. It is not possible within the EU to place a product on the market without completing the conformity assessment procedure and affixing the CE marking.
The manufacturer of the medical devices is responsible for the CE marking. If the manufacturer is not located in the European Union, he can appoint an authorized representative in the EU. If he does not do so, the importer is responsible for CE conformity as the person placing the product on the EU market.
Medical devices or not?
First of all, it is necessary to assess which products actually fall under the definition of medical devices in Regulation 2017/745. In addition, a risk class of medical devices has to be defined, since different requirements are sometimes placed on these classes.
Many questions of delimitation make these steps difficult.
Are colored contact lenses covered by the Medical Devices Regulation? To which risk class do the finished reading glasses belong? Which products are subject to transitional provisions for the implementation of the Medical Devices Ordinance?
We at asseso have the answers to these and other questions.
Conformity assessment and involvement of a Notified Body
Before manufacturers place a product on the market, they carry out a conformity assessment procedure. Which procedures can be chosen depends on the classification of the product. If the conformity assessment procedure requires the involvement of a Notified Body, the manufacturer can choose a Notified Body himself. However, the Notified Body must be the one authorized to carry out the conformity assessment activities for the types of products concerned. For Class I products, the intervention of a Notified Body is not required.
In any case, the manufacturer shall perform basic tasks that cannot be performed by an inspection body.
In total, the following steps must always be carried out:
- establishment and application of the quality management system for medical devices
- creation and application of the risk management system for medical devices
- compilation of the technical documentation
- conducting the clinical evaluation
- awarding UDI to products
- creation and application of the vigilance system
- determination of a "responsible person" for medical devices
- involvement of a Notified Body (for risk classes IIa, IIb, III, Is/m/r)
- affixing of the conformity marking and safety information
- preparation of the EU Declaration of Conformity
- registration in EUDAMED
- post-market monitoring and documentation
We at asseso can help you in individual areas or oversee the entire process. We check existing test reports or commission new ones, compile the technical documentation and marking elements and prepare your declaration of conformity.