As reported by devicemed, the new EU Medical Device Regulation (MDR) has been in force for over 100 days now. It provides a uniform legal basis for manufacturers, importers and distributors in the EU member states and tightens requirements such as those governing the purchase, storage, logistics, distribution and marketing of medical devices. Such requirements include the following, for instance:
- Information on CE marking
- EU conformity declaration
- Information accompanying the product in accordance with Article 10 (11) (e.g. separate labelling; instructions for use in the respective language of the EU member state in which the product is marketed).
- Name of the importer (for manufacturers outside the EU) or
- the name of the manufacturer(s) on the product
- Serial / unique device identifier (UDI) number.
In addition, medical devices must be tested for compliance as well as patient safety and product performance.
Notification of the BfArM
If the inspection reveals deviations, these must be clarified with the supplier (importer, manufacturer). If it is to be assumed that products are counterfeit or not in conformity with the law, the manufacturer, importer, EU authorised representative and the supervisory authority (Federal Institute for Drugs and Medical Devices, BfArm) must be notified accordingly.
No changes to products or introduce quality management
Each change to the product requires a new assessment of product conformity. This changes the role of dealer to manufacturer. The product must therefore not be modified in any way.
If a dealer makes any changes as contemplated by Article 16 (2), then a quality management system (QMS) must be introduced, which includes e.g. product packaging, information / documents, translations into the respective national language, testing for product conformity, manufacturer communication and an authority notification system.
Medical Device Law Implementation Act (MPDG)
The German Medical Device Law Implementation Act (MPDG, as reported by rade-e-bility) implements and/or specifies the requirements of the Medical Device Regulation 2017/745 with greater precision. According to Section 92 (1), the act of storing, offering, placing on the market or putting into service counterfeit medical devices may be liable to prison sentences; this may also apply if the products are already on the market.
Free initial consultation
trade-e-bility offers you cost-efficient, risk-oriented quality management for your medical equipment. The trade-e-bility consultants will be pleased to assist you. Please call +49/40/75068730-0 or send an e-mail to beratung@trade-e-bility.de if you have any questions.
