With our glossary you have quick access to the most important topics and explanations of technical terms and keywords.
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Accreditation
Issued to individuals that have been formally recognised as qualified to carry out certain tests or types of test under the EN 45011 standard. The accreditations issued to testing laboratories are particularly important in relation to products above Class I.
Active device
any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices. Software is also considered to be an active device.
Audit
An audit is the internal or external inspection of a system with a view to assessing compliance with set processes, instructions and requirements. Such inspections are a key component of certification processes, particularly in connection with quality management systems.
Accompanying product information
The information accompanying a medical device comprises:
• labelling
• user manuals
• any other relevant product information
Audit
An audit is the internal or external inspection of a system with a view to assessing compliance with set processes, instructions and requirements. Such inspections are a key component of certification processes, particularly in connection with quality management systems.
Adverse event
An adverse event is any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device
Authorised Representative
An Authorised Representative is 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.
Accessory for a medical device
An accessory for a medical device is 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).
Benefit-risk determination
A benefit-risk determination is the analysis of all assessments of benefit and risk of possible relevance for the use of the device for the intended purpose, when used in accordance with the intended purpose given by the manufacturer.
Biocompatibility
It must be demonstrated that the materials used in medical devices do not represent any biological hazards for the user or third parties when used for their intended purpose (EN ISO 10993-1).
Contract Research Organisations (also known as Clinical Research Organisations) – CROs
“CROs are service providers for the pharmaceutical and medical device manufacturing sectors.They support the pharmaceutical industry in planning, carrying out, and monitoring clinical (Phase I-IV) and non-interventional studies (NIS), including observational studies. They may assume full responsibility for these studies and clinical trials.
CE
Communautés Européennes (European Communities)
CE mark
The CE Mark was conceived primarily to ensure the safety of products designed for end users in the 30 member countries of the European Economic Area, including the members of what was then the European Community (EC) and later became the European Union (EU). The CE marking is frequently described as a ‘passport‘ for access to the EU’s internal market.
CE marking of conformity
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.
Case studies
Case studies are a type of (clinical) study. The evidence they provide is classified at Level 4. They are generally carried out without a written design document.
Common specifications (CS)
Common Specifications are a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to a device, process or system.
Classification
The categorisation of a medical device on the basis of the potential risks associated with it, in accordance with established classification procedures.
Clinical evaluation
Clinical evaluation is a systematic and planned process to continuously generate, collect, analyse and assess the clinical data pertaining to a device in order to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.
Clinical data
information concerning safety or performance that is generated from the use of a device and is sourced from the following:
clinical investigation(s) of the device concerned,
—clinical investigation(s) or other studies reported in scientific literature, of a device for which equivalence to the device in question can be demonstrated,
— reports published in peer reviewed scientific literature on other clinical experience of either the device in question or a device for which equivalence to the device in question can be demonstrated,
— clinically relevant information coming from post-market surveillance, in particular the post-market clinical follow-up;
Clinical performance
Clinical performance is the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer.
Clinical investigation
Any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device.
Clinical evidence
Clinical evidence is clinical data and clinical evaluation results pertaining to a device of a sufficient amount and quality to allow a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer.
Clinical benefit
Clinical benefit is the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health.
Clinical investigation plan
A document that describes the rationale, objectives, design, methodology, monitoring, statistical considerations, organisation and conduct of a clinical investigation.
Compatibility
Compatibility is the ability of a device, including software, when used together with one or more other devices in accordance with its intended purpose, to:
(a) perform without losing or compromising the ability to perform as intended, and/or;
(b) integrate and/or operate without the need for modification or adaption of any part of the combined devices, and/or
(c) be used together without conflict/interference or adverse reaction
Conformity
The extent to which product meets a requirement.
Conformity assessment
A conformity assessment is the process demonstrating whether the requirements of this Regulation relating to a device have been fulfilled.
Conformity assessment procedure
The conformity assessment procedure refers to the procedure used to determine whether a given product complies with the requirements of applicable legislation.
Conformity assessment body
A conformity assessment body is a body that performs third-party conformity assessment activities including calibration, testing, certification and inspection.
Custom-made device
A custom-made device is 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, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-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.
Corrective action
A corrective action is an action taken to eliminate the cause of a potential or actual non-conformity or other undesirable situation.
Digital healthcare applications (DiGA)
“A digital healthcare application is defined [by regulations] as a medical device that demonstrates the following characteristics:
– It is a medical device falling into Risk Class I or IIa (either according to the Medical Devices Regulation – MDR – or under the Medical Devices Directive –MDD – transitional regulations)
– The primary function of a digital healthcare application must be based on digital technologies.
– The medical purpose of the application must be achieved primarily by means of its principal digital function.
– The digital application must support the detection, monitoring, treatment or alleviation of illness, or the detection, treatment or alleviation of injuries, or be designed to compensate for injuries or disabilities.
– The digital application must be used by the patient, or jointly by the patient and a service provider.”
Distributor
A distributor is 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 until the point of putting into service.
Declaration of Conformity
By submitting an EC declaration of conformity, the ‘responsible manufacturer ‘or its representative declares that its medical device is compliant with the provisions of the MDD/MDR. The manufacturer takes sole responsibility for this declaration, which is legally binding. No medical device can be marketed in the EU without a Declaration of Conformity.
Device deficiency
A device deficiency is any inadequacy in the identity, quality, durability, reliability, safety or performance of an investigational device, including malfunction, use errors or inadequacy in information supplied by the manufacturer.
EC Declaration of Conformity
By submitting an EC Declaration of Conformity, the ‘responsible manufacturer’ or its representative declares that its medical device is compliant with the provisions of the MDD/MDR. The manufacturer takes sole responsibility for this declaration, which is legally binding. No medical device can be marketed in the EU without a Declaration of Conformity.
Economic operator
A manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3).
EUDAMED
EUDAMED is the EU’s medical devices database (currently in development).
EMA
European Medicines Agency
Electromagnetic compatibility (EMC)
Electromagnetic compatibility must be demonstrated for all electrically powered medical devices. Verification is generally provided in accordance with the EN 60601-1-2 standard. The evidence presented must confirm that the function of the medical device will not be disturbed by the presence of other electrically powered devices within the defined operating environment, and that the device in question will not disrupt the function of these other electrical devices.
EN ISO 13485
The EN ISO 13485 standard sets out the requirements for quality management systems for medical device manufacturers.
Ethics committee
An ethics committee is an independent body established in a Member State in accordance with the law of that Member State and empowered to give opinions for the purposes of this Regulation, taking into account the views of laypersons, in particular patients or patients’ organisations.
Federal Gazette (Bundesanzeiger)
The Federal Gazette is the centralised platform for official statements and announcements in Germany, as well as for legally significant notices to companies. You can find more information about the history and work of the Federal Gazette on the publisher’s website at https://www.bundesanzeiger.de
Federal Communications Industry Association (Bundesverband Industrie Kommunikation e.V. – BVIK)
Federal Association of Industry Communication
FDA - Food and Drug Administration (USA)
The regulator for groceries and medicines in the United States of America.
Failure Mode and Effects Analysis (FMEA)
FMEA is an analytical method for managing risk. The analysis looks for potential sources of errors that may pose a risk to the user or to others, or that may cause damage other equipment and/or property. It also identifies measures with the potential to influence the hazards concerned, the likelihood that a risk will materialise and/or be discovered, and other relevant factors.
Federal Joint Committee (Gemeinsamer Bundesausschuss – G-BA)
The Federal Joint Committee is Germany’s highest decision-making authority for self-regulatory bodies within the German health system, covering doctors, dentists, physiotherapists, hospitals and health insurers. Its guidelines determine the list of services provided by statutory health insurance funds covering over 70 million people and, by extension, which medical care services will be covered under statutory health insurance. The G-BA also regulates quality management measures for in-patient and outpatient care within the health system.
Falsified device
A falsified device is any device with a false presentation of its identity and/or of its source and/or its CE marking certificates or documents relating to CE marking procedures. This definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights.
Full refurbishment
For the purposes of the definition of manufacturer, this means the complete rebuilding of a device already placed on the market or put into service, or the making of a new device from used devices, to bring it into conformity with this Regulation, combined with the assignment of a new lifetime to the refurbished device.
Field safety notice
A communication sent by a manufacturer to users or customers in relation to a field safety corrective action.
Field safety corrective action
Corrective action taken by a manufacturer for technical or medical reasons to prevent or reduce the risk of a serious incident in relation to a device made available on the market.
German Federal Ministry of Health (Bundesministerium für Gesundheit – BMG)
Part of the Federal Ministry of Health’s role in the German healthcare system is to develop certain areas of the system (such as care) with a view to ensuring it is fit for the future.
German Medical Technology Association (Bundesverband Medizintechnologie – BVMed)
The German Medical Technology Association (known in Germany as BVMed) is the industry association for over 230 industrial and commercial firms within the medical technology sector. Its members include the 20 biggest manufacturers of consumer medical devices worldwide. You can find full details of our members, committees, services, publications and events here.
German Institute for Medical Documentation and Information (Deutsches Institut für Mendizinische Dokumentation und Information (DIMDI)
On 26 May 2020, the German Federal Institute for Drugs and Medical Devices (BfArM) was merged with the main functional units of the German Institute for Medical Documentation and Information (DIMDI) to create a single authority under the auspices of the BfArM.
German Specialist Association for Medical Devices (Fachvereinigung für Medizinprodukte)
The f.m.p. e.V. brings together associations from the medical devices industry and a range of service provider groups.
The body’s members provide capital goods and consumables to doctors and hospitals. It also supplies people with disabilities and physical limitations with systems designed to support them in their lives, including traditional rehabilitation aids and care equipment.
f.m.p. also plays a political role in representing its members in debates on economic, social and welfare policy.
This work is carried out at regional and national level within Germany, working together with specialist policymakers in parliaments and relevant ministries.
Generic device group
A generic device group is ‘generic device group’ means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics.
German National Association of Statutory Health Insurance Funds (GKV Spitzenverband)
“The German National Association of Statutory Health Insurance Funds is the central representative body for health insurance funds in Germany, both within the EU and internationally. It regulates the conditions for an intense competition in the provision of health and care services, ensuring they are both high quality and economically viable. The health of Germany’s approximately 73 million insurance policy holders is at the centre of everything it does.
Agreements and other decisions made by the German National Association of Statutory Health Insurance Funds apply to all health insurance funds, their regional organisations and, by extension, to virtually all individuals covered by statutory insurance. The German National Association of Statutory Health Insurance Funds supports health insurers and their regional organisations in fulfilling their obligations and asserting their interests.”
Global Medical Devices Nomenclature (GMDN)
GMDN is a system of internationally agreed generic descriptors used to describe all medical devices. The nomenclature is maintained and updated by the GMDN Agency.
Good Manufacturing Practice (GMP)
An international system of designations for medical devices.
General safety and performance requirements
The ‘general safety and performance requirements’ for medical devices are set out in Annex I of the MDR. Medical devices must meet all of these requirements. While some of them are specific in nature, others are open to interpretation. Compliance with these requirements must be evidenced as part of the conformity assessment procedure.
German Act on the Provision of Therapeutic Products and Medical Devices (Heil-und Hilfsmittelversorgungsgesetz – HHVG)
A law designed to improve the provision of therapeutic products and medical devices.
German Medical Technnical Aids Register (Hilfsmittelverzeichnis – HMV)
“Pursuant to Section 139 of Book V of the German Social (Sozialgesetzbuch [SGB] V), the National Association of Statutory Health Insurance Funds draws up a systematic, structured register of medical devices. This register lists all medical devices in respect of which statutory insurance providers are legally required to provide cover.”
German Medical Device Operators Ordinance (Medizinprodukte - Betreiberverordnung – MPBetreibV).
This ordinance describes the obligations operators of medical devices must meet in order to set up and use the medical device concerned in Germany.
German Medical Devices Act (Medizinproduktegesetz – MPG)
The German Medical Devices Act (MPG) of 2 August 1994 (Bundesgesetzblatt [German Legal Gazette] I p. 1963) implements the following legislation in German law:
• Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended by Directive 93/68 EEC
• Council Directive 93/42/EEC concerning medical devices, as amended by Directive 2001/104/EC and
• Regulation 98/79/EC on in-vitro-diagnostics.
German Medical Devices Safety Ordinance (Medizinprodukte-Sicherheitsverordnung– MPSV)
The German Medical Devices Safety Ordinance (MPSV) regulates the procedure to be followed for reporting incidents, among other provisions.
Health institution
An organisation the primary purpose of which is the care or treatment of patients or the promotion of public health.
Harmonised standard
A harmonised standard is a European standard as defined in point (1)(c) of Article 2 of Regulation (EU) No 1025/2012.
Ifa GmbH
“IFA GmbH is an information service provider for the pharmaceutical market. It provides information services including economic, legal and logistics data concerning goods available in pharmacies throughout Germany.”
Informed consent
Informed consent is a subject’s free and voluntary expression of his or her willingness to participate in a particular clinical investigation, after having been informed of all aspects of the clinical investigation that are relevant to the subject’s decision to participate or, in the case of minors and of incapacitated subjects, an authorisation or agreement from their legally designated representative to include them in the clinical investigation.
Initial importer (FDA)
The initial importer of the product into the United States must register with the US Food and Drug Administration (FDA). Under US law, an initial importer is defined as any importer that supports the marketing of a device not originally manufactured by a US manufacturer, and/or is responsible for the final delivery or sale of the device to the end user.
Importer (MDR)
Under the EU’s MDR, an importer is any natural or legal person established within the Union that places a device from a third country on the Union market.
Many of the general obligations to which importers are subject are set out in Article 13 of the Medical Devices Regulation and/or the In-Vitro Diagnostics Regulation.
In order to introduce a product to the EU market, an importer must check that the product carries the CE mark, that it is accompanied by the required documentation, that it is marked in accordance with the relevant regulations, and that the product has been assigned a UDI where required.
The importer should also check that the product is registered in EUDAMED.
Any importer who believes that a product is not in compliance with regulations must inform the manufacturer and its representative of this view, and must not introduce the product concerned into the market. If the importer has reason to believe that the product is counterfeit, or that it carries a serious health risk, it must also inform the relevant authorities.
Instructions for use
The instructions for use are the information provided by the manufacturer to inform the user of a device’s intended purpose and proper use and of any precautions to be taken.
Implantable device
An implantable device is any device, including those that are partially or wholly absorbed, which is intended:
— to be totally introduced into the human body, or
— to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure.
Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device.
Interoperability
Interoperability is the ability of two or more devices, including software, from the same manufacturer or from different manufacturers, to:
(a) exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or
(b) communicate with each other, and/or
(c) work together as intended.
IVD
In-vitro-Diagnostika
Investigator
An individual responsible for the conduct of a clinical investigation at a clinical investigation site
Investigational device
A device that is assessed in a clinical investigation.
Incident
An incident is any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect.
Intended use
Intended use is the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation
Label
A label is the written, printed or graphic information appearing either on the device itself, or on the packaging of each unit or on the packaging of multiple devices.
Making available on the market
‘Making available on the market’ is 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
MDEL - Medical devices establishment licence listig
The MDEL is the licence required to distribute medical devices in Canada. It is issued by the Canadian health authority Health Canada. An additional-product specific licence (known as an MDL, or medical device licence) is required for medical devices falling into higher categories.
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 trade mark.
Medical device registration number (Hilfsmittelnummer)
A 10-digit number assigned to medical devices included in the German Register of Medical Devices (Hilfsmittelverzeichnis – HMV). The register is administered by the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband).
Market surveillance
Market surveillance is the activities carried out and measures taken by competent authorities to check and ensure that devices comply with the requirements set out in the relevant Union harmonisation legislation and do not endanger health, safety or any other aspect of public interest protection.
MDR
MDR is the acronym for Regulation (EU) 2017/745 of the European Parliament and the Council regarding medical devices (the Medical Devices Regulation). The Regulation is designed to minimise any friction within the EU Single Market for medical devices. It sets out the requirements that manufacturers and their medical devices must meet in order to operate on the EU market.
Medical Devices (MEDDEV) documents
MEDDEV documents set out guidance from the European Commission on the implementation of applicable Directives and Regulations.
Medical aids
According to the definition given in German medical aids guidelines, medical aids are specific medical services provided by approved service providers. They include items designed to compensate for or replace impaired physical function, e.g. sight and hearing aids, prosthetics and orthopaedic equipment. All medical aids that can be provided under statutory health insurance in Germany (i.e. that are on the National Association of Statutory Insurance Funds list), are listed in the Register of Medical Devices (HMV).
Medical benefit
Pursuant to Section 139 SGB V, proof of medical benefit must be provided before a product can be listed in the register of medical devices.
The type and manner of verification required is described in the application form for the relevant product group, as is the documentation that must be submitted as part of this process.
Medical device
A medical device is 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.
The following products are also classed as medical devices:
– Devices for the control or support of conception;
— Products specifically intended for the cleaning, disinfection or sterilisation of devices as referred to in Article 1(4) and of those referred to in the first paragraph of this point.
Medical Devices Adviser (Medizinprodukteberater)
Under the German Medical Devices Act (Medizinproduktegesetz), all companies that brief specialist audiences on medical devices, and/or provide instructions on the correct use of medical devices, are required to nominate a Medical Devices Adviser, and to delegate certain tasks to this adviser (see Sections 32 and 33). This requirement only applies in Germany.
Medical Devices Directive (93/42/EEC)
Directive 93/42/EEC sets out the legal basis for introducing a medical device into the European Economic Area. Individual Member States are responsible for implementing this Directive in relevant national legislation. In Germany, its provisions have been incorporated into the Medical Devices Act (MPG). The Directive’s validity has been extended until May 2021.
MPSV - Medizinprodukte-Sicherheitsverordnung
Medizinprodukte – Sicherheitsplanverordnung MPSV regelt u.a. die Meldepflichten von Vorkommnissen.
Mehr dazu unter: www.bfarm.de
Notified body
European Union notified bodies are conformity assessment bodies designated in accordance with this Regulation. They work on behalf of the state to guide and monitor conformity assessments for various types of industrial products. In doing so, they act as ‘indirect public administration‘ bodies. As far as medical devices are concerned, notified bodies must be consulted on conformity assessments for products above class I.
Non-viable
Something having no potential for metabolism or multiplication.
Original Equipment Manufacturer (OEM)
An OEM is an original equipment manufacturer that produces the medical device in question, but does not market it under its own name.
Processing
Reprocessing is a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device
Procedure pack
A combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.
Putting into service
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.
Placing on the market
Placing on the market is the first making available of a device, other than an investigational device, on the Union market
Performance
Performance is the ability of a device to achieve its intended purpose as stated by the manufacturer.
Pre-qualification
“Pre-qualification represents a pre-competitive suitability test.
This phase was introduced in 2011 as a replacement for the previous ‘insurer approval’ (Kassenzulassung)issued to service providers in the medical devices sector. It is now a mandatory requirement for all companies who wish to have their product covered by statutory health insurance [in Germany].”
Pharmaceutical registration number (Pharmazentralnummer – PZN)
This is a supplier number similar to an ISBN. It is required for all pharmacies in Germany. Each individual product and quantity sold is assigned its own number.
Post-market surveillance
Post-market surveillance is all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions
Person Responsible for Regulatroy Compliance (PRRC)
Person responsible for regulatory compliance according to Article 15 of the EU MDR
QM logs
Logs are documents that can no longer be edited once they have been created. They are generally based on documents that have gone through multiple revisions, such as editable or regularly updated records within a management system.
REHADAT
“REHADAT is a project by the German Economic Institute in Cologne, funded by the Federal Ministry of Labour and Social Affairs via Germany’s Compensation Fund Ausgleichsfonds. “The REHADAT-portals provide quick access for disabled people and other interested parties to reliable information on all issues affecting the participation of disabled people in the labour market. Topics covered include medical aids, case studies, legal information, contact details, relevant literature, research, statistics, workshops, compensation payments and continued professional development.”
Responsible authority
In Germany, this is the relevant authority in the Federal State where the manufacturer is based. This authority serves as the first point of contact for all issues relating to the medical device.
Risk
The risk is the combination of the probability of occurrence of harm and the severity of that harm
Risk analysis
Risk analysis includes a systematic evaluation of all available information regarding the product, its manufacture, and the way in which it is used and disposed of, in order to identify potential hazards and assess any risks associated with it. A risk analysis in accordance with EN ISO 14971 must be included in the Technical Documentation.
Risk assessment
A risk assessment includes an assessment of the safety of the product on the basis of a risk analysis. A risk assessment in accordance with EN ISO 14971 must be included in the Technical Documentation as an evidential document.
Risk management
Involves the description and implementation of a management process for dealing with known and unknown hazards in accordance with EN ISO 14971.
Recall
A recall means any measure aimed at achieving the return of a device that has already been made available to the end user.
Registration system
The entirety of the statutory provisions governing registration requirements, along with all the institutions involved in registration.
HMV Representative
A service provided by BEO BERLIN®
Request for official statement (Anhörungsschreiben)
A request for an official statement (known in Germany as an Anhörungsschreiben), may be issued by the National Association of Statutory Health Insurance Funds (GKV Spitzenverband) as part of an application to be listed in the German Register of Medical Technical Aids (Hilfsmittelverzeichnis – HMV), for example. The request provides the applicant with the opportunity to state its position on any outstanding issues or other points requiring clarification before a final decision is taken on the application.
Single-use device
‘Single-use device’ means a device that is intended to be used on one individual during a single procedure;
Suitability for use
In relation to medical devices, suitability for use refers to whether the product can be used safely and reliably following appropriate briefing and/or training. All medical devices must be shown to be suitable for use as part of the conformity assessment procedure under the MDR.
Swiss Devices and Items List (Mittel und Gegenständeliste) – MiGEL
Switzerland’s Devices and Items List (MiGeL) regulates the medical devices and items covered by mandatory health insurance in Switzerland. The list covers medical devices and items used directly by the insured party or by any other individual who is involved in a medical examination in a non-professional capacity.
Subject
An individual who participates in a clinical investigation.
Serious public health threat
A serious public health threat is an event which could result in imminent risk of death, serious deterioration in a person’s state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time
Serious adverse event
A serious adverse event is any adverse event that led to any of the following:
(a) death,
(b) serious deterioration in the health of the subject, that resulted in any of the following:
(i) life-threatening illness or injury,
(ii) permanent impairment of a body structure or a body function,
(iii) hospitalisation or prolongation of patient hospitalisation,
(iv) medical or surgical intervention to prevent life-threatening illness or injury or
permanent impairment to a body structure or a body function,
(v) chronic disease,
(c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect.
Serious incident
A serious incident is any incident that directly or indirectly led, might have led or might lead to any of the following:
(a) the death of a patient, user or other person,
(b) the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health,
(c) a serious public health threat.
Software validation (SV)
The suitability test is carried out on the basis of a previously established requirements profile, and can be conducted from both a technical and staffing point of view.
Sponsor
A sponsor is individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation
Standard operating procedure (SOP)
A (standardised) operating procedure/process description.
Summary TEchnical Documentation (STED)
Summary technical documentation intended to demonstrate compliance with the fundamental principles of safety and performance as they apply to medical devices.
System
A system is a combination of products, either packaged together or not, which are intended to be inter-connected or combined to achieve a specific medical purpose
The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, – BfArM)
The Federal Institute for Drugs and Medical Devices (known by its German acronym BfArM), is an independent high-level Federal authority overseen by the German Federal Ministry of Health. Its remit is defined by the German Medical Devices Act (Medizinproduktegesetz – MPG) and the German Medical Devices Safety Plan Ordinance (Medizinprodukte-Sicherheitsplanverordnung – (MPSV).
Traceability
A product must be traceable with regard to:
• the origin of parts and materials;
• the way in which materials are processed;
• the positioning and distribution of the product following dispatch from the factory.
Technical Documentation
The Technical Documentation includes the verification documents required to ensure compliance with the general safety and performance requirements set out in Annex I of the MDR. Such documentation should be retained by the manufacturer or its representative in relation to all medical devices, and provided to the appropriate authorities on request.
User
A user is any healthcare professional or lay person who uses a device.
Unique device identifier (UDI)
A unique device identifier is a series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market.
Update
In this specific context, this term refers to updates to product groups within the German Register of Medical Devices (Hilfsmittelverzeichnis – HMV).
UMDNS - Universal Medical Device Nomenclature System
This system of nomenclature or for medical devices has been developed for the purposes of encoding medical devices.
Withdrawal
A withdrawal is any measure aimed at preventing a device in the supply chain from being further made available on the market.
