Any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

• diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
• diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
• investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
• providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,

The post-market surveillance system shall be suited: to actively and systematically gathering, recording and analysing relevant data on the quality, performance and safety of a device throughout its entire lifetime, and to drawing the necessary conclusions and to determining, implementing and monitoring any preventive and corrective actions. 

Data gathered by the manufacturer’s post-market surveillance system shall, in particular, be used:

• (a) to update the benefit-risk determination and to improve the risk management as referred to in Chapter I of Annex I;
• (b) to update the design and manufacturing information, the instructions for use and the labelling;
• (c) to update the clinical evaluation,
• (d) to update the summary of safety and clinical performance referred to in Article 32,
• (e) for the identification of needs for preventive, corrective or field safety corrective action,
• (f) for the identification of options to improve the usability, performance and safety of the device,
• (g) when relevant, to contribute to the post-market surveillance of other devices; and
• (h) to detect and report trends in accordance with Article 88. The technical documentation shall be updated accordingly.  

If in the course of the post-market surveillance, a need for preventive or corrective action or both is identified, the manufacturer shall implement the appropriate measures and inform the competent authorities concerned and, where applicable, the notified body. Where a serious incident is identified or a field safety corrective action is implemented, it shall be reported in accordance with Article 87.

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Risk management shall be understood as a continuous iterative process throughout the entire lifecycle of a device, requiring regular, systematic updating. In carrying out risk management, manufacturers shall:

• (a) establish and document a risk management plan for each device,
• (b) identify and analyse the known and foreseeable hazards associated with each device,

• (c) estimate and evaluate the risks associated with, and occurring during, the intended use and during reasonably foreseeable misuse,
• (d) eliminate or control the risks referred to in point (c) in accordance with the requirements of Section 4;  
• (e) evaluate the impact of information from the production phase and, in particular, from the post-market surveillance system, on hazards and the frequency of occurrence thereof, on estimates of their associated risks, as well as on the overall risk, benefit-risk ratio and risk acceptability; and  
• (f) based on the evaluation of the impact of the information referred to in point (e), if necessary, amend control measures in line with the requirements of Section 4.

Manufacturers shall establish, implement, document and maintain a risk management system.

Is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI. It is created following a request from the European Commission to one of these organisations. Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation. = Voluntary application, a means of demonstrating compliance with the regulations.

Shall cover all parts and elements of a manufacturer’s organisation dealing with the quality of processes, procedures and devices. It shall govern the structure, responsibilities, procedures, processes and management resources required to implement the principles and actions necessary to achieve compliance with the provisions of this Regulation. The quality management system shall address at least the following aspects:

• a strategy for regulatory compliance, including compliance with conformity assessment procedures and procedures for management of modifications to the devices covered by the system;
• identification of applicable general safety and performance requirements and exploration of options to address those requirements;
• responsibility of the management;
• resource management, including selection and control of suppliers and sub-contractors;
• risk management as set out in in Section 3 of Annex I;
• clinical evaluation in accordance with Article 61 and Annex XIV, including PMCF;
• product realisation, including planning, design, development, production and service provision;
• verification of the UDI assignments made in accordance with Article 27(3) to all relevant devices and ensuring consistency and validity of information provided in accordance with Article 29;
• setting-up, implementation and maintenance of a post-market surveillance system, in accordance with Article 83;
• handling communication with competent authorities, notified bodies, other economic operators, customers and/or other stakeholders;
• processes for reporting of serious incidents and field safety corrective actions in the context of vigilance;
• management of corrective and preventive actions and verification of their effectiveness;
• processes for monitoring and measurement of output, data analysis and product improvement.

All measures designed to ensure that the quality of orthopedic devices is maintained during storage and distribution. Quality assurance includes, in particular, good distribution practices.

GDPs are part of quality assurance which ensures that the quality of technical orthopedic devices is maintained in all phases of the distribution chain, from manufacture to delivery.

Corrective and preventive measures.

All products in stock that are sensitive to temperature, light, humidity or parasites.

All private individuals, end-users and distributors to whom the orthopaedic devices are sold or delivered.

A counterfeit product is a product that is deliberately mislabeled as to its identity and/or source. Counterfeiting can relate to either the brand or the products and can involve products that include original components or components that deviate from the originals, thereby distorting the end-users expectations of the original/authentic products.

In vitro diagnostic medical device means a medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, device or system used singly or in combination and intended by the manufacturer for in vitro testing of samples taken from the human body, including blood and donor tissue, solely or principally for the purpose of providing information:

• a physiological or pathological condition, or
• about a congenital malformation, or
• determine the security and degree of compatibility with potential recipients, or
• to test the effect of therapeutic measures

Any active medical device designed to be implanted, wholly or partially, surgically or orthopedically into the human body or through orthopaedic intervention in a natural opening and intended to remain in the body after such procedure.

Any natural or legal person in the supply chain, other than the manufacturer or importer, who makes a product available on the EU market.

Making a medical device available for payment or free of charge with a view to its distribution and/or use on the Belgian market, in the Member States of the European Union or in the States that are part of the European Economic Area on Belgian territory, whether it is a new or refurbished device.

A natural or legal person who manufactures or refurbishes a device or has a device designed, manufactured or refurbished and markets it under his name or trademark.

• any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or instructions for use which could lead or have led to the death or serious deterioration in the state of health of a patient or user,
• any reason of a technical or orthopaedic technical nature relating to the characteristics or performance of a device which, because of the abovementioned circumstances, has led to the systematic recall by the manufacturer of devices of the same type

A document which describes the way in which an operation is carried out and the means necessary to carry it out. Instructions differ from procedures in that, in general, they generally concern only a specific operation, service, machine or person.

A specific quantity of technical orthopedic products manufactured in a single process or in a single series of processes in such a way that they are assumed to be homogeneous.

The study and monitoring of incidents that may result from the use of orthopedic technical aids. It enables the withdrawal of dangerous devices from the market and the identification and elimination of defects in orthopedic devices with a view to improving the quality level of the devices and increasing the safety of patients and users.

A measure to prevent a problem from recurring in the future by addressing the cause of the problem.

Any natural or legal person, other than a distributor, who uses a medical device in the course of his professional activities.

Any natural or legal person established in the European Union and authorised in writing by a manufacturer to act on his behalf and in relation to the specific tasks set out in the legislation on orthopaedic devices.

Is a measure that is taken to eliminate the causes of a defect or other unwanted situation and to prevent their occurrence.

A non-compliant medical device is a medical device that does not meet the legal requirements for medical devices laid down in European and national legislation.

Any natural person who acquires or uses medical devices solely for non-professional purposes.

Description according to a logical, coherent and detailed plan, of the operations to be carried out, the measures to be taken, the technical means and the documentation to be used in order to ensure reproducible performance of an operation or series of operations. As far as possible, these procedures are expressed in the form of documents.

The extent to which a set of properties and characteristics meet requirements (standards).

The status of orthopaedic technical devices isolated physically or by other effective means pending a subsequent decision on their release, destruction or re-compliance (reprocessing).

The withdrawal of a medical device from the market by a recall organised by the distributor or manufacturer or at the request of the competent authorities.

The process of collecting and recording data to enable the history, implementation or location of what is being sought to be quickly retrieved.

Are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market.