Eu Mdr Definition of Legal Manufacturerngocthanh
1 – A distributor, importer or other natural or legal person shall assume the obligations of manufacturers when it takes any of the following measures: Economic operator – means a manufacturer, authorised representative, importer or distributor. A manufacturer might think of itself as a “private controller” who simply puts someone else`s medical device on the market under its name. This is not synonymous with delegation of the design and development of the device. In this case, the supplier of the final product is the “legal producer” and the “private controller” must carefully consider which aspects of Article 16 of the EU MDR apply to its activities. See: Are you a medical device manufacturer according to EU-MDR if you sell “only” medical items? If you purchase a device or IVD from an OEM and change the directions for use and labelling, including the company name on the label, you are considered a legal manufacturer under the MDR or IVDR. If you place the device on the market and your company name appears on the labelling/packaging, you are considered a “legal manufacturer” and must therefore have constant access to all technical documentation. Most OEMs won`t allow this, so MDR and IVDR will likely significantly limit this business model. Read our obituary on OBL/PBL in Europe. Q: When we say “distributor,” do we just mean the direct distributor or all distributors in the supply chain until it reaches patients? Does the manufacturer have to enter into quality agreements with all distributors in the supply chain? Guidance document MDCG 2019-15 (Guidance for Class I Medical Device Manufacturers) provides detailed information on the implementation of the requirements. These guidelines also apply to importers/distributors who would carry out activities that comply with the obligations of the “legal manufacturer”, as described in the section Is anyone selling “only” simple medical items a manufacturer of medical devices? (26) `interoperability` means the capability of two or more devices, including software, from the same or different manufacturers, A: The manufacturer and the Netherlands are responsible for inclusion in the SSCP in EUDAMED. The merchant is not responsible according to the regulations. A: The importer and distributor may be the same physical unit, but they must comply with the regulations outlined in the EU MDR for the regulatory roles of the importer and distributor.
The legal manufacturer can make the business decision to have as many importers and distributors as they want, but this is inefficient. The MDR obliges importers to include information in EUDAMED. The relationship between the contract manufacturer and the manufacturer (specification holder) under the EU MDR and IVDR will be much more participatory and engaged than under previous regulations. The EU`s MDR and IVDR will require a partnership based on trust, cooperation and enhanced communication. A: There is no “MDR certification process” for economic operators. The economic operator may be checked by the notified body as a critical supplier or participate in an unannounced inspection by the competent authority. A certified quality system adds a level of control when a Canadian organization conducts an audit. Note that all critical subcontractors, not just economic operators, are eligible for NB visits if the legal manufacturer is ISO 13485 certified. The most important part of the Regulation is addressed to the manufacturer with obligations defined in Chapters II (supply of MD), III (identification and traceability) and V (conformity assessment). The Annex is complementary. Economic operator – a manufacturer, authorised representative, importer, distributor or the person referred to in Article 22, systems and process batches, requirements (1) and 3).
Traceability is essential for all raw materials and components used in the manufacture of regulated medical devices. Manufacturing materials such as mold releases, cutting oils and fluids, and tumbling media must be registered and subject to change control, as regulatory evaluation by the manufacturer (specification holder) is required. A robust traceability program will help prevent fraudulent or counterfeit raw materials and components from entering systems and facilitate complaint investigations, field corrections and recalls. A: An essential contractor/manufacturer is not an economic operator. The legal manufacturer is the party that puts the device on the market. The responsibilities of a manufacturer`s subcontractor should be defined in a quality or other legal agreement. It is for the legal producer to determine, where appropriate, the role of the economic operator. A: The importer and the manufacturer are the only economic operators who place the product on the market.
The distributor supplies the product. As a manufacturer, you have the option to use the same entity to assume the regulatory role of importer and distributor, but this is not mandatory. For example, you may have one importer in the EU, but many distributors in the EU. Also note that according to Article 31, the manufacturer and importer (and authorised representative) must have a unique registration number (SRN). The change control processes used by contract manufacturers shall ensure that at least one communication and feedback mechanism is in place to enable the manufacturer (contract holder) to assess all changes for their possible regulatory impact on the status of the marketing authorisation.