The European Union (EU) is approaching its deadline to implement the Medical Device Regulation (EU MDR). As the transition period ends on May 26, 2020, a wider and clearer regulatory scope for medical devices is just around the corner.
The EU MDR establishes requirements for manufacturers and Notified Bodies, including expanded clinical evidence requirements, more regulatory oversight, additional requirements for in-vitro device (IVD) manufacturers, and stricter supervision of Notified Bodies (NB).
To help Medical Devices manufacturers and other companies within the industry with this challenging process, SoftGroup prepared a set with the core terminology regarding the EU MDR and IVDR you should known navigating the new regulation demands, terms, and acronyms.
Active Implantable Medical Device Directive – AIMDD (90/385/EEC)
Any active medical device that is intended to be introduced into the human body for diagnostic or therapeutic purposes, and which is intended to remain in place e.g. pacemakers or defibrillators. The MDR replaces the AIMDD to specify the Essential Requirements manufacturers and importers must meet to apply the CE Mark to AIMDs in the EU.
Clinical data is information on the safety and performance of a medical device that is generated from and during its use.
Clinical Evaluation Plan – (CEP)
A procedure that allows companies to collect clinical data and clinical evaluation results with an aim to demonstrate safety and performance as well as the overall positive benefit-to-risk-ratio for a medical device through critical evaluation of the collected elements.
Clinical Evaluation Report – (CER)
A document that collates all data proving the intended purpose of a device, its target groups, its clinical benefits along with the indications and contraindications.
Information that provides conclusive proof of the safety, performance, and efficacy of a medical device in the context of its intended use. Clinical evidence can be generated through clinical investigations conducted on the medical device in question, or a demonstration of safety and performance-based scientific literature, or based on data for comparable devices i.e. equivalence. The MDR has set a more stringent bar of equivalency for medical devices, especially of a higher risk class, to obtain the CE Mark.
Competent Authority – (CA)
A body within the government of the Member States of the European Union that transposes the requirements of the MDR into national law.
Conformité Européenne – (CE Mark)
Products sold with the CE mark within the extended European Single Market have been assessed to meet high safety, health, and environmental protection requirements.
Corrective and Preventive Actions – (CAPA)
This term refers to improvements to an organization’s processes taken to eliminate the causes of non-conformities or other undesirable situations. The MDR requires manufacturers of medical devices to have clearly documented procedures for corrective and preventive action as part of their overall Quality Management System (QMS).
Declaration of Conformity – (DoC)
Confirms the CE-marked products’ compliance with the applicable legislation. According to the MDR, a DoC will now omit references to the MDD completely. Each DoC will now mention the Unique Device Identifier (UDI) and any reclassification of the product.
Device Risk Class
Classification of a medical device by the MDR references four classes (I, IIa, IIb, and III) considering the intended purpose of the device, its inherent risks relative to the duration of use, and invasiveness.
European Authorized Representative – (EC REP)
Serves as a liaison between the manufacturer and the National Competent Authorities (CA’s). Responsibilities include assistance with device registrations, submission of Technical Documentation and Declaration of Conformity to the CA when required, and assistance with Field Safety and Corrective Action (FSCA) reporting. The EC REP must be identified on all product labeling throughout Europe.
European Databank on Medical Devices – (EUDAMED)
A secure, central, web-based portal for the exchange of information between national CAs and the European Commission. Under the MDR, this will be interoperable and publicly accessible. The new database is designed to be multifunctional, i.e. a registration, collaboration, and notification system.
A procedure to analyze a manufacturer’s current level of compliance by examining their products’ Technical Documentation (TD) and processes. A thorough gap assessment will generate a task list for updating their procedures and documentation to facilitate the compliance transition from MDD to MDR.
A ‘grandfathered’ or legacy medical device is one that was already on the market before an applicable directive or regulation. Under the MDD, some devices were grandfathered and allowed to be marketed without formal approval. The MDR excludes all grandfathering of products, so even if a device has been on the market for more than 20 years, a new CE mark will now be required after going through all standard compliance procedures.
The MDR requires all implantable devices to incorporate an ‘implant card’ containing information about the device e.g. duration of use, UDI etc. to make information easily available and accessible to various stakeholders. This will allow the patient to identify themselves in case Field Safety Corrective Action (FSCA) is to be undertaken and allow clinical staff to obtain information about special care or needs for patients in emergency situations.
In Vitro Diagnostic Regulation – (IVDR)
The IVDR is the new regulatory directive for manufacturing and placing on the market in vitro diagnostic medical devices on the European Single Market. It will replace the EU’s current Directive on in vitro diagnostic medical devices (98/79/EC).
Article 10(9) of the MDR states that the manufacturer is obliged to implement an effective QMS to meet the regulations for compliance. The ISO 13485:2016 is the international standard, issued by ISO, that provides regulatory requirements for a medical device QMS. While Product documentation is not specifically mentioned in the MDR, it is generally taken as a gold standard for medical device manufacturers i.e. compliance with ISO 13485:2016 QMS requirements will help compliance with MDR.
While the MDD focused on regulatory compliance in the pre-market stage, the MDR promotes a life-cycle approach to medical device regulation. The implicit aim is to ensure that CE-marked devices are not only safe and effective at launch but continue to meet state-of-the-art performance throughout the life of the product. Manufacturers will need to perform a continuous review of clinical and technical documentation, and potential updates to the device design will need to become an integral part of the product life cycle to not only obtain but also maintain the CE mark.
The term ‘medical device’ most commonly refers to a piece of equipment that comes into direct contact with the patient and is used to treat or diagnose a clinical condition.
Medical Device Coordination Group – (MDCG)
MDCG advises and assists the European Commission and Member States in ensuring a harmonized implementation of the new EU MDR. The Group publishes legally non-binding guidance documents in accordance with Article 105 of Regulation 745/2017 to help ensure uniform application of the relevant regulations within the EU.
Medical Device Directive – (MDD)
(93/42/EEC) The MDD (Council Directive 93/42/EEC) came into force in 1993 with the aim of harmonizing the laws relating to medical devices within the EU. For a manufacturer to legally place a medical device on the extended EU Single Market (i.e. have the CE mark applied), the requirements of the MDD had to be met. This has been replaced by the EU MDR which comes into force in May 2020.
Medical Device Single Audit Program – (MDSAP)
Allows a single audit of a medical device manufacturer’s QMS for compliance with the standard regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. Addressing the QMS requirements of the MDR and MDSAP facilitates efficiency and avoids multiple costly audits especially if the manufacturer is also placing devices into any of the markets of the MDSAP regulatory authorities.
New Approach Notified and Designated Organizations – (NANDO)
All Notified Bodies which are designated to assess medical devices are listed on the EU Commission’s NANDO website. As and when Notified Bodies are designated under the MDR or IVDR, they are added to the NANDO MDR or NANDO IVDR databases.
Notified Bodies – (NBs)
A Notified Body is an organization designated by an EU Member State to assess the conformity of certain products before being placed on the market. As per the Regulation, the existing Notified Bodies need to be recertified according to MDR regulations to ensure the safety and effectiveness of the products they were evaluating and certifying and to ensure conformity. The NBs currently certified and those in the process are updated to the NANDO website
Quality Management System – (QMS)
A structured system of processes covering all aspects of design and manufacturing, supplier management, risk management, clinical data, and labeling. The MDR contains explicit requirements for manufacturers to establish, implement, and manage a quality management system that meets the relevant and applicable requirements and will be scrutinized for conformity by the NBs.
Risk Management System – (RMS)
Involves the identification, understanding, control, and hazard prevention during its use. Compared to the MDD, the MDR defines risk management as an iterative process throughout the lifecycle of a device. As per the regulation, the manufacturer must establish, document, implement and maintain a system for risk management as part of the quality system and show evidence of an RMS plan that documents known or potential risks and provides detailed steps to eliminate or minimize these hazards.
Serious Adverse Events – (SAE)
Serious adverse events are critical device-related adverse incidents. These can be classified as cases of the device malfunction, deterioration in device performance, inadequate instructions, or labeling that may or may not result in death or serious injury or may lead to death or serious deterioration in the state of health of the patient. The incident must be reported to the CA of the member state where the incident occurred. In preparation for the MDR, a new set of adverse event codes were published for patient outcome/patient problems that are available here.
While the MDD had no specific provisions on the traceability of medical devices, the MDR seeks to ensure the transparency and traceability of EU devices in the interest of patient safety. The most important element of this is the Unique Device Identifier (UDI) for each device along with device labeling in electronic and paper forms and details of the organization’s EC representatives’ symbol, name, and address, etc. on the labels.
The MDR was published on 25th May 2017 and replaces the Medical Device Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC) and comes into force on May 26th, 2020. During the intervening three years i.e. the transition period, medical devices can be placed on the market under the current EU Directives as well as the new regulation. After the transition period, all devices placed on the market must conform to the MDR.
Unique Device Identifier – (UDI)
The UDI is the bar-coding of all medical devices on the European Single Market using a standard format. This is a new regulation by the MDR that requires that UDI information be placed on the label and/or package of medical devices. More specific requirements on labeling and several device types are available in Annex VI, Part C of the MDR.
Devices that are classified as a higher risk class after evaluation of their clinical and technical documentation are considered up classified.