Today marks a landmark event for medical device manufacturers around the globe: the date of full implementation of the EU’s MDR. Starting today all new medical device registrations that fall within the scope of the European Medical Device Regulation (MDR) must be carried out according to the new regulations. Devices registered under the previous directives will be valid until the expiration of their certificates, or until May 27, 2024. Devices registered under the previous directives that remain on the market must still comply with the requirements of the new Regulation regarding post-market surveillance, market surveillance, vigilance, and the registration of economic operators. Full implementation of IVDR will not occur until May 26, 2022.
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Overviews of changes
The following articles provide overviews of changes to medical device regulations under MDR and IVDR and how they will affect medical device manufacturers and distributors.
6 Major Differences Between EU’s MDR/IVDR and MDD/IVDD
The European Union has established the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) as replacements to the Medical Devices Directive (MDD) and ln Vitro Diagnostic Devices Directive (IVDD), which had previously been in place for almost 25 years. These new regulations aim to ensure the effectiveness and safety of medical devices marketing within the European Union
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MDCG Guidance on Significant Changes
The Medical Devices Coordination Group (MDCG) has issued a guidance document dedicated to the significant changes to medical devices subject to regulation under the Medical Devices Directive 93/42/EEC (MDD) or Active Implantable Medical Devices Directive 90/385/EEC (AIMD) with regard to the transitional provisions of the Medical Devices Regulation 2017/745 (MDR).
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EC Decision on Standardization for Medical Devices
The European Commission (EC) has issued a new regulation regarding standardization aspects in the context of Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation 2017/746 (IVDR).The new regulations set forth the measures necessary to ensure that any and all medical devices allowed to be imported, marketed or used within the European Union are compliant with the applicable safety and performance standards, providing the highest level of public health protection.
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Changes to Eudamed
Eudamed is the European Union’s database for medical devices, which was founded in 2011. This database is a web-based platform that stores all relevant regulatory information regarding medical devices received from manufacturers and notified bodies. The main purpose behind the establishment of Eudamed is to provide an information exchange system between the European Commission and competent authorities in the European Union Member States. This includes such information as: registry of manufacturers, authorized representatives and devices, declaration of conformity, and data on incidents or near-incidents during use of medical devices. Eudamed is not a public database and is not accessible by the public.
Under the new changes, Eudamed database will now also store information regarding postmarket surveillance activities, safety and clinical performance studies, and periodic safety update reports, and will provide more detailed information on clinical investigation data, manufacturers, and device registrations. The details on the Eudamed changes have been thoroughly covered in Article 33 of the official document mentioned above.
MDCG Guidance on EUDAMED Alternatives
With the launch of EUDAMED postponed until May 2022, the Medical Device Coordination Group (MDCG) has published a guidance document dedicated to harmonized administrative practices and alternative technical solutions until EUDAMED is fully functional.
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EC on Management of Legacy Devices
The European Commission (EC) has published a document describing the way in which Legacy Devices should be identified in the EUDAMED system, as well as the approach to be applied for Unique Device Identifiers assigned to such devices.
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EC Announces the Launch of Actor Registration Module
The European Commission (EC), a union-wide authority responsible for medical devices regulations, has announced the launch of the first of six EUDAMED modules – the Actor registration module.
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European Commission has Announced New Nomenclature
The European Commission (EC) has released two new guidance related to the nomenclature of medical devices. The first document published by the EC describes the “Classificazione Nazionale Dispositivi medicini” or the CND; The second guidance is dedicated to the European Medical Device Nomenclature (EMDN) established to be used by manufacturers for the purpose of registration in the EUDAMED database.
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Scope and Classification of Products
Although the classification system itself has not changed, several new rules regarding the classification of substance-based devices have been established. All devices containing substances that will be introduced to and/or absorbed by the body will rely on a totally different classification system. As a result, many devices will be reclassified to higher-risk classes. This has been detailed in the following Articles: 1, 2, 22, 23, 51, and 52
MDCG Guidance on IVD Classification Rules
The Medical Device Coordination Group (MDCG) has published guidance on classification rules for in vitro diagnostic medical devices (IVDs). The document is dedicated to certain classification aspects under the In Vitro Diagnostic Medical Devices Regulation (IVRD) 2017/746 – the new EU-wide regulation on IVDs which soon will replace the appropriate EU Directive.
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European Council Published Draft of Second Corrigendum to MDR 745
The European Council, the European body defining the general directions of the EU policy, recently announced they have published the draft of the second corrigendum to the Medical Devices Regulation (MDR) 2017/745. The most important amendments included in the Corrigendum are related to Class I medical devices.
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MDCG Guidance for Class I Medical Device Manufacturers
The Medical Device Coordination Group (MDCG) has issued the first revision of guidance notes to the manufacturers of Class I medical devices initially published in December 2019. In particular, the document intends to provide medical device manufacturers and other parties involved with recommendations regarding compliance with the applicable regulations in the context of MDR postponement.
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The MDCG’s Class II Medical Device Guidance
The Medical Device Coordination Group (MDCG), the advisory body assisting the European Commission on issues related to the implementation of legislation regulating the circulation of medical devices, has published several guidances. The first guidance clarifies the requirements for the sampling of the Class IIa/b medical devices under the Medical Devices Regulation 2017/745 (MDR) and also the Class B/C in vitro diagnostic medical devices under the In Vitro Diagnostic Regulation 2017/746 (IVDR). The second guidance is dedicated to codification under the MDR.
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EC MDCG Issued Guidance in Qualification and Classification of Software Under the MDR/IVDR
The Medical Device Coordination Group (MDCG), a special advisory body of the European Commission (EC) issued a detailed guidance on software classification according to the new medical device regulations: 2017/745 (MDR) and 2017/746 (IVDR).
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MDCG Visual Guide to Medical Device Software
The Medical Device Coordination Group (MDCG) has published a new visual guide describing the approach to be applied when determining whether software in question is a medical device.
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Changes to Notified Bodies
A notified body is an organization designated by a member state of the European Union to carry out the assessment of whether a product that may be placed on the market is compliant with all the obligatory standards and procedures. The major change presented by MDR and IVDR concerns the supervision of notified bodies, which means that a substantial number of the current notified bodies may lose their designation or see changes in the scope of what they’re authorized to do. On top of that, notified bodies will have more responsibilities as they will have to consult with the European Commission on clinical evaluation and conduct surveillance assessments. Just as before, notified bodies will provide assessment only of higher class medical devices.
EC MDCG Issues Notified Body Assessment Form
The Medical Device Coordination Group (MDCG) of the European Commission (EC) issued a final version of the assessment form intended to be used by designated authorities to select a notified body.
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Notified Bodies and Conformity Assessment in the EU
The new medical device regulations 745/2017 (MDR) and 746/2017 (IVDR) have introduced an entirely new assessment procedure. This is a crucial process and should be carried out by Notified Bodies.
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NBOG on Designation and Notification of Conformity Assessment Bodies
The Notified Body Operations Group (NBOG), an organization established by the European Commission to improve the performance of notified bodies earlier in 2000, has published a best practice guide dedicated to the designation and notification of conformity assessment bodies.
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Addition of Unique Device Identification (UDI) System
The implementation of Unique Device Identification into EU medical device regulations has been long-awaited and much needed. The addition of a UDI system aims to increase the traceability of all medical devices on the market by placing a unique code on the label of the device. UDI offers a number of benefits and will be primarily used for reporting serious incidents and identifying counterfeit medical devices. The details of this new system have been thoroughly explained in the following Articles: 18, 19, 27, and 87.
EC on the Unique Device Identification System
The European Commission (EC) has published a detailed FAQ dedicated to the most important questions related to the Unique Device Identification (UDI) system established under the Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic medical device Regulation 2017/746 (IVDR).
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UDI and Changes to UDI’s: MDCG Guidance
The Medical Device Coordination Group (MDCG) issued guidance dedicated to the Unique Device Identification (UDI) system implemented by the Medical Device Regulation 2017/745 (MDR) and In Vitro Diagnostic Device Regulation 2017/746 (IVDR).
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Changes to Clinical Evaluation Processes
New changes are also tightening the area of clinical investigations and postmarket clinical follow-up. All clinical evidence must be updated for existing medical devices and must be clear, convincing, and publicly available. Additionally, clinical evaluation reports and summaries of safety and clinical performance for implantable devices and Class III devices should be updated at least once every year.
MDCG Q&A Document on Clinical Investigation
The Medical Device Coordination Group (MDCG) has published questions & answers on clinical investigations carried out in accordance with the provisions of the Medical Devices Regulation 2017/745(MDR), which replaces the appropriate Directive.
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MDCG Regulatory Guidance on Clinical Evidence
The Medical Device Coordination Group (MDCG) issued a guidance document on clinical evidence for medical devices already marked with the CE marks under the Medical Devices Directive 93/42/EEC (MDD) or Active Implantable Medical Devices Directive 90/385/EEC (AIMDD), (the Directives), in the context of the new Medical Device Regulation 2017/745 (MDR).
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MDCG Guidance on Clinical Evaluation and Equivalence
The Medical Device Coordination Group (MDCG) has issued guidance documents for medical device manufacturers and notified bodies dedicated to the most important aspects of clinical evaluation related to the concept of equivalence.
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MDCG Guidance on Safety Reporting in Clinical Investigations
The Medical Device Coordination Group (MDCG) has issued guidance dedicated to the safety reporting in clinical investigations under the Medical Device Regulation 2017/745 (MDR).
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MDCG Post-market Clinical Follow-Up (PMCF)
The Medical Device Coordination Group (MDCG) has published a template of the post-market clinical follow-up (PMCF) plan to be used by medical device manufacturers to place their devices on the EU market. In accordance with the Medical Device Regulation 2017/745 (MDR), the PMCF constitutes an important part of the responsibilities of the medical device manufacturer related to post-market surveillance. The aforementioned regulation also implements a set of requirements the PMCF plan should meet.
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More Useful Information
European Commission Published Guidance on Vigilance System
European medical regulating authority, the EC, recently published a new guidance on medical device vigilance systems covering issues related to the distribution of information between national competent authorities. The document, intended to clarify definitions, set forth the form of Manufacturer’s Incident Report and describes the difference between particular information exchange systems – EU NCAR and IMDRF NCAR
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Do Your Labels Comply with the E.U.’s MDR?
Although the European Medical Devices Regulation (MDR) will not go into full effect until 2022, if your medical device company does business in the European Union, you may need to modify your labeling before then. The EU MDR has laid out requirements that further obfuscate the labeling operations of medical device manufacturers. Now, companies will have to include more information on their labels than was previously required to remain compliant through to 2020.
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