Quality assurance agreement for manufacturers of medical products

The companies, which intend to manufacture medical products, using the other enterprise’s capacities, need to adjust relations with a contract manufacturer. The Quality assurance agreement is the most efficient instrument for regulating similar relations in legal contemplation.

The practice in application of the present allocation model for manufacturing processes is quite popular among the global producers. It allocates the manufacturing processes between a brand owner (OBL – Own Brand Labeling) and an actual manufacturer of the complete product (OEM – original equipment manufacturer).

The term of “Own Brand Labeling” (OBL) refers to the specific procedure, which is to be followed by the medical products’ manufacturer, when he is engaged into marketing and sale of devices with labeling in form of a national conformance mark under the proper trade mark.

! The industry-specific technical regulations for the medical products: Decrees by Ukraine’s Cabinet of Ministers №753, 754, 755 designate the manufacturer of OBL as a legal manufacturer, even if he doesn’t take part in actual manufacture of the medical products or technical equipment. 

In such a way, the relations between the company, which manufactures a device and makes marking in the form of the national conformance mark, known as the original equipment manufacturer (OEM), and the company intending to sell it OBL, should be governed by the agreement. This agreement must specifity the roles of the parties, along with the ways of communication and techniques of gaining access to the confidential information for a manufactured product.

The prevailing legislation provides no specific requirements towards the quality assurance agreement, and it doesn’t contain the very definition of the present agreement as well.

The legislator also doesn’t establish well-defined quality criteria, which the performed work under the quality assurance agreement must comply with, therefore the legal relations are to be entirely governed by the agreement. In the meantime, the quality assurance agreement provides for the possibility of resort to some kind of well-established practice by the parties. The said practice must regard the imposition of requirements towards the products’ quality on the contract manufacturer.

Therefore, the European practice of law and market practice need to be addressed, so that the quality assurance agreement and it’s prime criteria could be defined in a complete and comprehensive way.

According to European practice, the quality assurance agreement – is a treaty for control and evaluation of any aspects in respect of the project, manufacturing process of the medical products and equipment. The control, specified in the treaty, may be extended to the kind of services as well. The purpose of the specified control – is the increase of probability for implementation of the established minimum quality standards for the medical products. The other purpose is – the preservation of these characteristics in the context of storage, transportation and administration of the medical products by the similar manufacture’s order giver.

In such a way, the quality assurance agreement contains data-sheets for the basic technical parameters, along with organizational parameters and processes between them, defined by the agreement’s parties. It sets out minimal requirements, which will be employed for administering quality system of the medical products’ actual manufacturer’s (OEM). And the agreement also prescribes rights and duties for quality assurance in respect of the medical products, supplied by the manufacturing company (OEM) to the Brand Owner company of OBL. It gets attributed the brand (trading mark) of the aforementioned company before being supplied.

The present agreement’s scope if the quality assurance, that is – determination of all the quality assurance operations, envisaged between the agreement’s parties. This includes the due measures, assumed by the actual manufacturer (OEM) for assurance of quality standards in respect of the medical products, coordinated in the present agreement.

The precedent condition of the quality assurance agreement is compliance with the requirements of the quality management system in coherence with ISO 13485 or/and of the quality standards, which get employed in the course of production.

The quality assurance agreement governs the following important aspects:

  • The right of ownership to a trading mark, an industrial pattern and a patent;
  • Duties of warning on part of the OEM of any changes in the production process;
  • Procedure for handling claims and complaint letters;
  • Procedure for conducting mutual control;
  • Requirements for the Quality management system of the actual ОЕМmanufacturer;
  • Procedure for accomplishment of manufacturing stages, such as:
    • engineering and development;
    • production sector
    • labeling;
  • Procedures of quality control in respect of the medical products, carried-out subject to compliance with the established quality standards.

The present agreement may also encompass:

  • A notification about changing the status of the OEM products’ certification;
  • The ways of gaining access to the technical documentation, data-sheets for the medical products, production reports, bacterial purification records and testing records;
  • A notification about alterations in the commodity’s data-sheet;
  • Procedure for decision-making in respect of the medical products, which doesn’t conform to the quality requirements;
  • Observation methods of OBL over the activities, conducted by the actual OEM manufacturer;
  • Procedure for responding to the consumers’ complaint letters by the parties. These complaint letters tackle the quality of manufactured medical products, they were submitted by OEM or OBL. And they address the topics of defaults, touch upon the subject of adequacy, quality, durability, fail-safety, occupational safety and efficiency;
  • Procedure of warranted relations and service relations;
  • Procedure for alteration of the design documentation and technical documentation;
  • Monitoring of the labeling process of products;
  • Oversight of the commodities delivery and dispatch;
  • Requirements for transportation and storage of finished goods;
  • Implementation of risk management philosophy.

The quality assurance agreement may serve as an independent agreement, so too an exhibit to the supply agreement between the brand owner and an actual manufacturer.

“Archimed” company possesses the necessary experience and the proper practice, which matured over the years and it furnishes legal services for the competent execution of the quality assurance agreements between the aforementioned entities.

This is what we offer to the order givers:

  • the necessary counseling services;
  • we investigate all the nuances and the problem points, which emerge or may emerge during entry into them (the agreements);
  • we draw up the agreements according to the order giver’s conditions;
  • we carry-out a preliminary analysis and an inspection of conformance to the prevailing legislation’s requirements, of the agreement’s editions, offered to the trademark owner by the contract manufacturers;
  • we establish legal counselling in the course of negotiations and entry into quality assurance agreements at all the stages, jointly with the Order Giver.

Get more detailed consultation by sending us a brief request or calling the number below.