Medical Device Regulation
Here you will find all Instructions For Use and Declarations of Conformity. You will also find all our Technical Templates which can be used for your own compliancy in your workshop
Here you will find all Instructions For Use and Declarations of Conformity. You will also find all our Technical Templates which can be used for your own compliancy in your workshop
MDR Suite – A source of information for Prosthetic & Orthotic Professionals
The aim of the new EU-wide and uniform regulations is to ensure patient safety and to enhance the quality of medical devices on the European market for the benefit of all. Manufacturers in particular are facing major challenges, as the implementation of the new requirements involves high effort and costs. The extent to which the changes arising from those regulatory replacement affects your business depends on the role you hold.
This website focuses on the new Medical Device Regulation 2017/745 (MDR) for manufacturers of custom-made devices. This new Medical Device Regulation 2017/745 (MDR) will play a significant role of patient care providers that create products like prosthetics, orthotics or wheelchairs. Creating prosthesis or orthosis is patient specific and therefore requires special documents which this website can help provide as information or as a template. This website will not take over your responsibility or liability, but we can offer support to be compliant to the Medical Device Regulation 2017/745 (MDR).
Relevant economic operators
For an overview of the different roles and responsibilities, the corresponding definitions, subcategories and further information are found here. The person responsible for regulatory compliance (PRRC) in particular is examined in detail.
PRRC
The new Medical Device Regulation (MDR) requires the appointment of a "person responsible for regulatory compliance" (PRRC).
The following must appoint a PRRC
Manufacturers (of serial and custom-made devices)
Authorised representatives
Importers, distributors or other persons, if the obligations of the manufacturer apply to them
Note: Importers and distributors are not required to appoint a PRRC, if no obligations of a manufacturer apply to them.
Responsibilities
The PRRC shall at least be responsible for ensuring that:
the conformity of the devices is appropriately verified in accordance with the quality management system under which the devices are manufactured before a device is released;
the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
the post-market surveillance obligations are complied with;
the reporting obligations (reporting of serious incidents and field safety corrective actions, trend reporting, analysis of serious incidents and field safety corrective actions, analysis of vigilance data) are fulfilled;
in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV applies.
Internal or external PRRC?
Manufacturers, including manufacturers of custom-made medical devices, shall have available within their organisation "at least one person responsible for regulatory compliance." This means it should be an internal PRRC.
Note: Micro and small enterprises “shall have such a person permanently and continuously at their disposal”. This exemption allows the appointment of an external PRRC for micro and small enterprises.
The MDR defines micro and small enterprises as follows:
Micro enterprise: fewer than 10 employees and annual revenue less than € 2 million.
Small enterprise: fewer than 50 employees and annual revenue less than € 10 million.
Qualification of the PRRC
The PRRC must possess the requisite expertise in the field of medical devices, which shall be demonstrated as follows:
Either | Or |
|---|---|
a diploma, certificate or other evidence of formal qualification in law, medicine, pharmacy, engineering or another relevant scientific discipline | four years of professional experience in regulatory affairs or in quality management systems relating to medical devices. |
and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; | Note: Manufacturers of custom-made devices may demonstrate the requisite expertise by having at least two years of professional experience within a relevant field of manufacturing. |
Authorised representative
Authorised representative means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.
Distributor
Distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up to the point of putting it into service."
As distributor, you have to check the devices for the following aspects:
CE marking is applied
Declaration of conformity is available
Necessary information is supplied with the device (e.g. instructions for use)
Unique device identifier (UDI) is available (relevant by 2025)
Furthermore, your responsibilities include:
Follow storage or transport conditions outlined by the manufacturer.
Record information regarding complaints, non-compliance and incidents and forward them to the manufacturer.
Work together with competent authorities if requested.
Document which devices were bought and sold (traceability of the device).
Note: Patient names do not need to be traced, but other economic operators do.
Health institution
Health institution means an organisation whose primary purpose is the care or treatment of patients or the promotion of public health." [EU-MDR Article 2 (36)]
Based on this definition, patient care providers could be considered a health institution.
If products are used in a health institution, they are considered as being "placed on the market".
Importer
Importer means any natural or legal person established within the Union that places a device from a third country on the Union market."
Manufacturer
Manufacturer means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.
As a patient care provider, you can provide your patients either with a serial medical device or a custom-made medical device that has been individually manufactured for that particular patient. It is necessary to distinguish between these two types of products in order to know which requirements of the MDR apply to you.
The effort required to be a manufacturer of serial medical devices is much greater than for custom-made medical devices.
Manufacturers of serial medical devices
The MDR specifies the following obligations for manufacturers of serial medical devices:
A full quality management system according to Article 10 must be implemented.
There must be a written declaration of conformity as well as a technical documentation.
The devices must be marked with the CE marking of conformity.
There must be a person responsible for regulatory compliance (PRRC).
Economic operators that devices were received from or supplied to must be identified.
Manufacturers of custom-made medical devices
The MDR specifies the following obligations for manufacturers of custom-made medical devices:
A statement according to Annex XIII must be drawn up for the custom-made device and according to Article 22 for the patient solution.
Devices must be marked as "custom-made device".
There must be a person responsible for regulatory compliance (PRRC).
Economic operators that devices were received from or supplied to must be identified.
The following processes must be implemented:
Risk management
Clinical evaluation
Post-market surveillance (PMS)
Vigilance
Notified body
Notified body means a conformity assessment body designated in accordance with this Regulation.
Notified bodies are state-authorised bodies that – depending on the product and its risk class – carry out tests and assessments within the framework of the conformity assessment to be carried out by the manufacturer and certify its correctness according to uniform assessment standards.
Appointment of the PRRC
The appointment of the PRRC must be made in writing. Depending on your role as economic operator, you can select the respective template for the appointment letter here.
Letter of appointment for Authorised Representatives
Letter of appointment for Manufacturers
Letter of appointment for Manufacturers of custom-made devices
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Find out your role!
The prerequisite for implementing the MDR requirements is the correct understanding of the economic operators. It is therefore necessary that you can assign yourself and your patient care activities to one or more roles described by MDR. This decision tree will help you to do so. You need only answer a few questions to see the appropriate role or the economic operator to which you are assigned.
Download the decision tree here!
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Are you already well prepared?
At some point you will reach the moment where you say:
"We have revised all necessary existing processes or even introduced new processes and are now well established."
In order to remove the last uncertainties you may still have, we provide you with a compliance checklist that you can use to check whether you have really thought of everything. It is easy for something, even a small detail, to be forgotten. And that would be very unfortunate, considering the work you and your team have put into implementing this project.
Select your role to find out the respective requirements
Distributors
Distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up to the point of putting it into service.
MDR article | MDR requirement | Comment |
|---|---|---|
Article 14 (1) | When making a device available on the market, distributors shall, in the context of their activities, act with due diligence in relation to the applicable requirements. | Compliant if all requirements of article 14 are fulfilled. |
Article 14 (2) | Before making a device available on the market, distributors shall verify that all of the following requirements are met: | Compliant if either the factors are checked directly or there is a contract with the manufacturer of purchased devices that outlines the competences of each side. |
Article 14 (2) | In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph, the distributor may apply a sampling method that is representative of the devices supplied by that distributor. | If devices are checked, the use of a known and scientific sampling method for compliance is allowed. |
Article 14 (2) | Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the member state in which it is established. | If you are aware that you are not allowed to sell unchecked devices, this is compliant. |
Article 14 (3) | Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer. | Compliant if either the factors are checked directly or there is a contract with the manufacturer of purchased devices that outlines the competences of each side. |
Article 14 (4) | Distributors that consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufacturer's authorised representative and the importer. Distributors shall co-operate with the manufacturer and, where applicable, the manufacturer's authorised representative and the importer and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as appropriate, is taken. Where the distributor considers or has reason to believe that the device presents a serious risk, it shall also immediately inform the competent authorities of the member states in which it made the device available, giving details, in particular, of the non-compliance and of any corrective action taken. | Be able to get in contact with manufacturers about complaints and non-conformities. |
Article 14 (5) | Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available shall immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative and the importer. They shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request. | Be able to get in contact with manufacturers about complaints and non-conformities. |
Article 14 (6) | Distributors shall, upon request by a competent authority, provide it with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device. | You need to work with your competent authority and provide necessary documents on request. |
Article 14 (6) | Distributors shall be considered to have fulfilled the obligation referred to in the first subparagraph when the manufacturer or, where applicable, the authorised representative for the device in question provides the required information. Distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market. Distributors, upon request by a competent authority, shall provide free samples of the device or, where that is impracticable, grant access to the device. | You need to work with your competent authority and provide necessary documents on request. |
Manufacturers
Manufacturer means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark. As a patient care provider, you can provide your patients either with a serial medical device or a custom-made medical device that has been individually manufactured for that particular patient. It is necessary to distinguish between these two types of products in order to know which requirements of the MDR apply to you.The effort required to be a manufacturer of serial medical devices is much greater than for custom-made medical devices.
MDR article | MDR requirement | Comment |
|---|---|---|
Article 10 (1) | When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation. | If all processes and documents mentioned in the requirements below are available and used, this shall be compliant. |
Article 10 (2) | Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I. | Have a risk management process and documents for all custom-made devices and patient solutions. |
Article 10 (3) | Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF. | Have a clinical evaluation process and documents for all custom-made devices and patient solutions. |
Article 10 (16) | Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law. Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law. | Insurance for damage compensation must be in place to achieve compliance. |
Article 15 (1) | Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications: | If a person responsible for regulatory compliance has been appointed, this requirement is fulfilled. |
Manufacturers of custom-made devices
MDR article | MDR requirement | Comment |
|---|---|---|
Article 10 (1) | When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation. | If all processes and documents mentioned in the requirements below are available and used, this shall be compliant. |
Article 10 (2) | Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I. | Have a risk management process and documents for all custom-made devices and patient solutions. |
Article 10 (3) | Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF. | Have a clinical evaluation process and documents for all custom-made devices and patient solutions. |
Article 10 (16) | Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law. Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law. | Insurance for damage compensation must be in place to achieve compliance. |
Article 15 (1) | Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications: | If a person responsible for regulatory compliance has been appointed, this requirement is fulfilled. |
Annex XIII (1) | For custom-made devices, the manufacturer or its authorised representative shall draw up a statement containing all of the following information: | If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled. |
Annex XIII (1) | '— the name and address of the manufacturer and of all manufacturing sites, | If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled. |
Annex XIII (1) | '— if applicable, the name and address of the authorised representative, | If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled. |
Annex XIII (1) | '— data allowing identification of the device in question, | If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled. |
Annex XIII (1) | '— a statement that the device is intended for exclusive use by a particular patient or user, identified by name, an acronym or a numerical code, | If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled. |
Annex XIII (1) | '— the name of the person who made out the prescription and who is authorised by national law by virtue of their professional qualifications to do so, and, where applicable, the name of the health institution concerned, | If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled. |
Annex XIII (1) | '— the specific characteristics of the product as indicated by the prescription, | If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled. |
Annex XIII (1) | '— a statement that the device in question conforms to the general safety and performance requirements set out in Annex I and, where applicable, indicating which general safety and performance requirements have not been fully met, together with the grounds, | If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled. |
Annex XIII (1) | '— where applicable, an indication that the device contains or incorporates a medicinal substance, including a human blood or plasma derivative, or tissues or cells of human origin or of animal origin as referred to in Regulation (EU) No 722/2012. | If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled. |
Annex XIII (2) | The manufacturer shall undertake to keep available for the competent national authorities documentation that indicates its manufacturing site or sites and allows an understanding to be formed of the design, manufacture and performance of the device, including the expected performance, so as to allow assessment of conformity with the requirements of this Regulation. | Control and document your manufacturing processes |
Annex XIII (3) | The manufacturer shall take all the measures necessary to ensure that the manufacturing process produces devices that are manufactured in accordance with the documentation referred to in Section 2. | Control and document your manufacturing processes. As a minimum, the manufacturing specification should be checked, e.g. record fitting or measurements of geometrical specifications delivered by the PCC. |
Annex XIII (4) | The statement referred to in the introductory part of Section 1 shall be kept for a period of at least 10 years after the device has been placed on the market. In the case of implantable devices, the period shall be at least 15 years. | Compliant if the documentation is planned to be stored for at least 10 years. |
Annex XIII (5) | The manufacturer shall review and document experience gained in the post-production phase, including from PMCF as referred to in Part B of Annex XIV, and implement appropriate means to apply any necessary corrective action. In that context, it shall report in accordance with Article 87(1) to the competent authorities any serious incidents or field safety corrective actions or both as soon as it learns of them. | Have a post-market surveillance (PMS) process and documents for all manufactured custom-made devices and patient solutions. |
Download your compliance checklist here!
Here you find three lists that can be used for self assessment. Please note that if you are acting in the role of different economic operators, several checklists are relevant for you.
MDR – Compliance Checklist Manufacturer of custom-made medical devices
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Requirements towards patient care providers
When you fabricate and provide a custom-made device for a patient, you are a manufacturer of custom-made devices and must comply with the following requirements:
Draw up a statement according to Annex XIII for the custom-made device and Article 22 for the patient solution.
Mark devices as „custom-made device“.
Have a person responsible for regulatory compliance (PRRC).
Economic operators that devices were received from or supplied to must be identified.
In addition to that, you must implement the following processes:
Risk management
Clinical evaluation
Post-market surveillance (PMS)
Vigilance
Risk Management
The risk management process requests the creation of a risk management file per patient solution group.
The risk management system is a regulatory requirement.
The main aspect is to identify hazards with the products and to identify measures for risk control.
A risk management file consists of:
RM plan
Risk analysis and control
RM report
Risk Management
The risk management process requests the creation of a risk management file per patient solution group.
The risk management system is a regulatory requirement.
The main aspect is to identify hazards with the products and to identify measures for risk control.
A risk management file consists of:
RM plan
Risk analysis and control
RM report
Clinical evolution
The clinical evaluation is generally applicable to the patient solution.
The clinical benefit of a device must be shown based on clinical data.
This is a regulatory requirement for each product.
Systematic and methodical approach
Reproducibility of search and conclusions is very important.
PMS
PMS requires to plan and document post-production activities.
PMS has to be conducted for each product.
The activities should follow proactive and reactive approaches.
Information from the market has to be collected, evaluated and processed.
Continuous safety and performance of products must be ensured.
Vigliance
Vigilance ensures that problems are identified and communicated as soon as possible.
Potential problems with the products must be identified.
If necessary, a report to authorities must be issued.
Report template has changed (new coding system).
Reporting timelines have changed (shortened).
It must be investigated whether required field action must be taken (e.g. recall or safety notice).
Documentation Effort
The documentation effort depends on the activity that is performed and thus on the role that you as a patient care provider currently hold. We have compared the documentation effort for three selected economic operators.
Manufacturer of serial-produced medical device | Manufacturer of custom-made medical device | System-Producer |
|---|---|---|
Obligations for manufacturers of MD | Obligations for manufacturers of CMD | Documentation acc. Article 22 (2) |
Documentation acc. Annex II & III | Documentation acc. Annex XIII Section 2 | Statement acc. Article 22 |
Declarations of Conformity | Statement acc. Annex XIII | |
CE marking of conformity | ||
Determine Basic UDI-DI | ||
Register in EUDAMED |
Frequently Asked Questions
We take the questions of the affected patient care providers seriously and compile them here. Do you have any other questions? Find the answer you are looking for here!
The appointment is made by letter of appointment from the company. This letter must be signed by a person sufficiently authorised to represent the company, preferably by the company’s managing directors. The letter of appointment must be countersigned by the PRRC. A template “Letter of Appointment” is available.
Yes. A manufacturer must have available at least one PRRC within its organisation. This means that an internal PRRC needs to be appointed. This also applies to manufacturers of custom-made devices. Exceptions are made for micro and small enterprises. They may appoint an external service provider to act as their PRRC. The authorized representative may also appoint an external PRRC.
The following supporting documents can be used for this purpose:
Employment contract evidencing that the person works in the area of regulatory affairs or in quality management and also since when he or she has done so.
Organisation chart evidencing the function
Evidence of training completed on topics such as quality management, medical device law, market surveillance, risk management, reporting
Records such as audit reports and approval of documents
If the company concerned is a German company and the person has already acted as a safety officer under Section 30 German Medical Devices Act (MPG), thus performing some of the tasks of a PRRC, the registration of this person with the German Institute of Medical Documentation and Information (DIMDI) as a safety officer can also be used as evidence of the relevant professional experience.
If other Member States have hitherto had in place statutory provisions in accordance with national medical device law which required a responsible person who performed some of the tasks of a PRRC, proof of this function can also be used as evidence of the relevant professional experience.
Yes, the PRRC has comprehensive documentation obligations. Where possible, templates will be made available to keep the administrative effort to a minimum and support the PRRCs in the performance of their duties.
Yes, according to the Medical Device Regulation, a number of persons may be jointly responsible for regulatory compliance. In this case, their respective areas of responsibility must be stipulated in writing.
However, this option will not be made use of during the introductory phase. If necessary, we will decide at a later date whether more than one person should be appointed in light of the comprehensive duties and responsibilities.
Micro and small manufacturers are not required to appoint a PRRC within their organization but shall have such a person permanently and continuously at their disposal. Therefore, the appointment of an external PRRC is an option. An agreement must be concluded with the external service provider. This agreement should stipulate that the person assuming the task of the PRRC has the qualifications required by the Medical Device Regulation (MDR). It must also me agreed that the manufacturer will have this person permanently and continuously at their disposal.
In addition, the person that assumes the role of PRRC should sign the letterhead to confirm that he/she accepts the office and duties and he/she has the qualifications required. Annexes 1 and 2 must also be completed. Deviating from the template the letterhead should indicate that the PRRC is an external PRRC: “ We herewith appoint [title, first and last name], [function], employee of [external service provider] as External Person responsible for regulatory compliance (PRRC) according to Article 15 REGULATION (EU) 2017/745 …”.?This provides a document that can be presented to the authorities if required.
Yes, under certain conditions. According to article 15(1) every manufacturer (including manufacturers of custom-made devices) shall have available at least one PRRC within their organisation. Only micro and small businesses (>50 employees, >10 Mio. € Revenue) are allowed to not have such a person within their organisation, as long as they have one permanently at their disposal.
This is not defined in the MDR. Please refer to the national regulations in the respective countries.
Yes, the MDR requires a prescription, so that the device can be categorised as a custom-made device. Please note that based on national provisions even CPO may be allowed to issue such prescription.
Yes, paperwork is still ok as long as all required contents is available. The MDR does not mention any format.
Yes. The PRRC must be registered in the electronic EUDAMED database. Even though the EU Commission has now given notice that the setting up of EUDAMED with all its new functions will probably not be completed before May 2022, the appointment of the PRRC must be carried out in due time, by 26 May 2020.
Glossary
The glossary provides definitions of the most important terms specified in the MDR. It is not necessary to look up terms in the legal text of the MDR – find the definitions and explanations you need here.
Accessory for a medical device means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s).
[EU-MDR Article 2 (2)]
CE marking of conformity or CE marking means a marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in this Regulation and other applicable Union harmonisation legislation providing for its affixing.
[EU-MDR Article 2 (43)]
Custom-made device means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person's professional qualifications which gives, under that person's responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.
However, serial-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are serial-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised person shall not be considered to be custom-made devices. [see EU-MDR Article 2 (3)]
Custom Made devices are a special type of medical device
All requirements for medical devices therefore apply to custom-made devices as well
Exemptions are clearly highlighted by „except for custom-made devices“
Custom-made devices are only the parts that are individually manufactured for a specific patient with specific specifications
Medical device means 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, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease
diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability
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
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means […].
[EU-MDR Aricle 2 (1)]
System means a combination of products, either packaged together or not, which are intended to be inter- connected or combined to achieve a specific medical purpose.
[EU-MDR Article 2 (11)]
Procedure pack means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.
[EU-MDR Article 2 (10)]
Find detailed explanations about the following roles here :
Authorised representative
Distributor
Health institution
Importer
Manufacturer
Notified body
Person responsible for regulatory compliance (PRRC)
Making available on the market means any supply of a device, other than an investigational device, for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.
[EU-MDR Article 2 (27)]
Placing on the market means the first making available of a device, other than an investigational device, on the Union market.
[EU-MDR Article 2 (28)]
Putting into service means the stage at which a device, other than an investigational device, has been made available to the final user as being ready for use on the Union market for the first time for its intended purpose.
[EU-MDR Article 2 (29)]
Compotent advice on MDR
