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The clinical trial world and the medical device industry are laden with acronyms. Even experienced practioners can have trouble keeping up, and if you’re new to the sector it can get a little confusing. We’ve put together a simple glossary to help if you’ve come across a term or acronym you’re not familiar with. We hope it helps!
Term |
Definition |
| 21 CFR 814 | Code of Federal Regulations Title 21 part 814 – Premarket Approval of Medical Devices |
| 21CFR 807 | Code of Federal Regulations Title 21 part 807 – Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices |
| ADE | Adverse Device Effect: adverse event related to the use of an investigational medical device. – This includes any adverse event resulting from insufficiencies or inadequacies in the instructions for use, the deployment, the implantation, the installation, the operation, or any malfunction of the investigational medical device – This includes any event that is a result of a use error or intentional misuse. |
| AE | Adverse Event: 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 |
| AIMD | Active Implantable Medical Device – all AIMDs are class III medical devices in the EU |
| Basic UDI-DI | MDR and IVDR define Basic UDI-DI as the primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity |
| Benefit-risk determination | 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 |
| BS EN ISO 14155:2020 | The international standard that sets out good clinical practice for conducting medical device clinical investigations using people. BS EN ISO 14155:2020 establishes the processes and methodologies to protect people’s rights, safety and well-being, and to ensure the credibility of results. Clinical Investigations that comply with MDR and IVDR will need to comform to this standard |
| CDRH | Center for Devices and Radiological Health: is the FDA center responsible for overseeing the medical device program. |
| CE Marking of Conformity (CE Marking) | The marking by which a manufacturer indicates that a device is in conformity with the applicable requirements set out in the MDR and other applicable EU harmonisation legislation. See MDR Chapter II |
| Clinical Evaluation | 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 |
| CEP | Clinical Evaluation Plan. For minimal requirements for an MDR-compliant CEP see Annexe XIV, Part A, section 1 of MDR |
| CIP | Clinical Investigations Plan. See MDR Chapter 1, Article 2 (47) for a full description of the key elements of the CIP as required under MDR. The CIP must be defined in such a way as to confirm or refute the manufacturer’s claims regarding the safety, performance and aspects relating to benefit-risk of devices as referred to in Article 62(1) of MDR |
| Class I |
Medical devices are Class I devices under MDR IF they are: a) Non-invasive devices which come into contact with injured skin or mucous membrane and if they are intended to be used as a mechanical barrier, for compression or for absorption of exudates The US FDA defines Class I devices as devices which are “not intended for use in supporting or sustaining life or of substantial importance in preventing impairment to human health, and they may not present a potential unreasonable risk of illness or injury |
| Class IIa | See MDR Annexe X Chapter III for the complete device classifcation rules for MDR. Class IIa covers a wide range of devices, including most invasive devices and most software. |
| Class IIb | Usually more complex than Class IIa devices, Class IIb devices are generally medium to high risk and will often be devices installed within the body for periods of 30 days or longer. Examples include ventilators and intensive care monitoring equipment. See MDR Annexe X Chapter III for the complete device classifcation rules for MDR |
| Class III | Devices that usually sustain or support life, are implanted, or present potential unreasonable risk of illness or injury. Examples of Class III devices include implantable pacemakers and breast implants. 10% of medical devices fall under this category. See MDR Annexe X Chapter III for the complete device classifcation rules for MDR |
| Common specifications |
MDR allows manufacturers to make use of harmonized standards for evidence. Where harmonized standards do not exist or are insufficient, or specific criteria are lacking, Common Specifications shall be applied. The Medical Device Coordination Group (MDCG)is tasked to develop such common standards alongside designated expert panels and expert laboratories (Article 106) |
| Conformity Assessment | The assessment process by which a medical device obtains a CE Mark; See MDR Chapter V, Section 2 and Appendices IX to XI |
| DoA |
Required dates of application under the regulations: Date of Application of the MDR – 26 May 2021. Date of Application of the IDVR – 26 May 2022 |
| Economic operator | Manufacturer, Authorised Representative, Importer or Distributor of the medical device |
| eCONSENT | The process by which patients record consent via the use of interactive, multimedia technologies |
| eCRF | Electronic Case Report Form |
| EDC | Electronic Data Capture |
| eDIARY | Electronic Diary used by patients for the recording and collection of Patient Reported Outcomes (PROs). Many studies have shown conclusively that compliance with protocols for PROs is much higher than with traditional paper diaries |
| ePRO | Electronic Patient Reported Outcome. ePRO includes the use of eDiaries (see above) but also includes site based gathering of data with questionnaires completed in a supervised environment when patients come in for their scheduled visits. |
| eTMF | Electronic Trial Master File |
| EUDAMED |
Eudamed is the European Databank on Medical Devices. It’s a secure, web-based portal that acts as a central hive for the exchange of information between national competent authorities and the European Commission. EUDAMED is structured around 6 interconnected modules and a public website: The module on Actor registration has been available since December 2020 |
| FDA | In the USA the Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation |
| GSPR | General Safety & Performance Requirements; see Annexe 1 of MDR, section 1 states: “Devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way that, during normal conditions of use, they are suitable for their intended purpose. They shall be safe and effective and shall not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety, taking into account the generally acknowledged state of the art.” |
| IVDR | The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is the new EU legislation applicable to in vitro diagnostic (IVD) and will be applicable from May 26 2022 |
| Market surveillance | Market surveillance is the prevention and investigation of abusive, manipulative or illegal trading practices in the securities markets. Market surveillance helps to ensure orderly markets, where buyers and sellers are willing to participate because they feel confident in the fairness and accuracy of transactions. With respect to market surveillance in the context of MDR, read MDR Section 3, article 93. |
| MDCG | Medical Devices Coordination Group, established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.The purpose of this group is to advise on regulatory development and to provide guidance on legislation |
| MDD | Medical Device Directive. Council directive 93/42/EEC. The current legislation regulating medical devices in the EU. |
| MEDDEV | MEDDEV stands for MEDical DEVices Documents. The MEDDEV Guidance Documents are developed by various working groups on behalf of the European Commission to assist stakeholders in implementing directives related to medical devices. |
| MDR | The coming legislation for medivcal devices in the EU that comes in to effect (Date of Application) on 26 May 2021. The full title is: REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC |
| MedDRA | A subscription-based product of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), MedDRA or Medical Dictionary for Regulatory Activities is a clinically validated international medical terminology dictionary-thesaurus used by regulatory authorities and the biopharmaceutical industry during the regulatory process, from pre-marketing (clinical research phase 0 to phase 3) to post-marketing activities (pharmacovigilance or clinical research phase 4), and for safety information data entry, retrieval, evaluation, and presentation.[1] Also, it is the adverse event classification dictionary |
| Notified body | The organisations mandated by the regulator to provide rigorous regulatory and quality management reviews and product certifications for medical device manufacturers. A list of EU notfied bodies can be found here: https://ec.europa.eu/growth/tools-databases/nando/index.cfm?fuseaction=directive.notifiedbody&dir_id=34 |
| PMCF | Post Market Clinical Follow-up. See MDR Annexe 14 Part b: “PMCF shall be understood to be a continuous process that updates the clinical evaluation referred to in Article 61 and Part A of this Annex and shall be addressed in the manufacturer’s post-market surveillance plan. When conducting PMCF, the manufacturer shall proactively collect and evaluate clinical data from the use in or on humans of a device which bears the CE marking and is placed on the market or put into service within its intended purpose as referred to in the relevant conformity assessment procedure, with the aim of confirming the safety and performance throughout the expected lifetime of the device, of ensuring the continued acceptability of identified risks and of detecting emerging risks on the basis of factual evidence.” |
| PMS | Post Market Surveillance. PMS is carried out systematically and proactively by manufacturers to collect and review the experiences had by users of their devices. The purpose of PMS is to identify any need for corrective action. PMS is undertaken in accordance with a PMS plan, in cooperation with authorised representatives and distributors. Other economic operators may also need to contribute to PMS. Article 83 of MDR and Article 78 of the IVDR set out the requirements for PMS. A key change in MDR is that the PMS MUST be integral to the manufacturer’s quality management system (QMS). PMCF or Post-market Performance Follow-up (PMPF – for IVDs), are elements of the overall PMS system proposed by the manufacturer. |
| QMS | Quality Management System is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization’s purpose and strategic direction. The internationally recognizesd standard for QMS for medical device manufacturers is: ISO 13485:2016; it is FDA QSR and MDR EU 2017/745 Compliant |
| SADE | Serious Adverse Device Effect: Adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event (SAE). See MEDDEV 2.7/3 revision 3 |
| SAE | Serious Adverse Event: Adverse event that: a) led to a death, injury or permanent impairment to a body structure or a body function. b) led to a serious deterioration in health of the subject, that either resulted in: – a life-threatening illness or injury, or – a permanent impairment of a body structure or a body function, or – in-patient hospitalization or prolongation of existing hospitalization, or – in medical or surgical intervention to prevent life threatening illness c) led to foetal distress, foetal death or a congenital abnormality or birth defect. See MEDDEV 2.7/3 revision 3 |
| SOP | Standard Operating Procedure, a critical part of the QMS and refers to a document that sets out the critical policies, processes and activities that comprise the clinical investigation process |
| Sponsor | In MDR Article 2(49), the Sponsor is defined as: ‘any individual, company, institution or organisation which takes responsibility for the initiation, for the management and setting up of the financing of the clinical investigation. |
| TR 20416:2020 | Documented process guidance for post-market surveillance, intended for use by medical device manufacturers. TR 20416:2020 is consistent with relevant international standards, in particular ISO 13485 and ISO 14971 |
| UDI | Unique Device Identifier (UDI) means 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 |
| USADE | Unanticipated Serious Adverse Device Effect |
| Vigilance | The reporting of serious incidents and field safety corrective actions; see MDR Chapter VII, Section2, Article 87 |
