Below are five examples to illustrate the importance of re-evaluating the corresponding agreements. We have also defined some practical steps to comply with the rules that can be taken: for example, distributors must certify that a device is labelled CE and that it contains an EU compliance declaration and an IDU. A sampling method can be used to confirm compliance. If in doubt, a distributor is required not to put the device on the market and to inform the manufacturer and importer that the device must be brought into compliance. If the distributor has “reason to believe” that there is a serious risk, he is obliged to inform the appropriate authority. 7 QMS quality repair management action system on non-compliant hardware in order to make acceptable as the planned use of post-processing action on non-compliant equipment, in order to meet the requirements of RMS risk management scrap system action on hardware not compliant with its originally intended supplier use The supplier provides product to the customer. The term supplier includes, under its guidance, contractors, consultants, sister organizations and higher organizations. Reference Papers 21 CFR Part 820 Quality SystemVerordnung GHTF/SG3/N15R8 Implementation of Risk Management Principles and Activities within a GHTF/SG3/N Quality Management System17:2008 Quality Management System Medical Devices Guide for Control of Products and Services Provided by Suppliers iso 9001:2008 Quality Systems Quality Requirements For Medical Devices Presentation Page 5 of 17. The MDR requires a contract between the manufacturer and the device manufacturer to access the technical documentation of this device. The contract must expressly give the manufacturer of the new device unlimited access to the technical documentation of the existing long-term device. One of the most seismic changes is the general concept of “economic actors” and the regulatory function assigned to them under the MDR.
Manufacturers, LES, importers and distributors are all considered economic operators under the MDR. The three directives on medical devices, which were implemented in the 1990s when the EU began regulating medical devices, do not include explicit obligations for distributors. This does not mean that distributors have not had an important role to play in complying with the legislation since then. Additional provisions for economic operators were incorporated in 2008 into the new legal framework (NLF), which consists of Regulation (EC) 765/2008, Decision 768/2008/EC and Blue Guide, and have been incorporated into recent transpositions of medical device legislation in most EU Member States. But let`s start at the beginning. In general, Article 14 does not provide for a legal obligation for merchants to introduce a QMS if they do not make specific adjustments to a medical device (e.g.B. reconditioning or making available and translation of the legal information covered in Schedule I of the MDR, Section 23 on demetic and instructions for use). In the latter case, the distributor assumes responsibility for changes to a medical device and not only needs a QMS, but also has it certified by a notified body (Article 16 of MDR). To achieve the equivalence of existing products on the market, manufacturers must demonstrate that they are technically, biologically and clinically equivalent. In itself, this is not a departure from the existing system.
However, as a new requirement, a manufacturer must also be able to demonstrate equivalence by having access to equivalent data.