Regulation (EU) 2017/745 – also known as the Medical Devices Regulation (MDR) has been adopted on May 25, 2017 and will replace the Medical Devices Directive 93/42/EEC (MDD) and Active Implantable Medical Devices Directive 90/385/EEC (AIMDD). There is a transition period of 3 years making the Regulation fully applicable on May 26, 2020. There are massive changes compared to the MDD confronting manufacturers with numerous challenges.
Major Regulatory Changes
For instance, there are amended and new classification rules. Some producers might find their products grouped in higher risk classes under the MDR. There will be an extended version of the Essential Requirements, now called the General Safety and Performance Principles or Requirements (SPR). Also, the provisions for clinical evaluation and Post-Market Surveillance (PMS) have been revised. The corresponding documents will be subject to enhanced scrutiny.
The general process for MDR compliance is reflected below.
MDR Compliance Process
- Appoint your European Authorized Representative
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- Identify all EU Directives/Regulations applicable to your product (such as MDR, WEEE, EMC etc.)
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- Select and perform the Conformity Assessment Procedure applicable to your product
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- Check your device against the General Safety and Performance Requirements (annex I)
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- Identify the applicable harmonized standards for your product
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- Prepare a Technical File (annex II and III) and implement a Quality Management System
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- Select a Notified Body (for classes Is, Im, Ir, IIa/b and III) and sign your Declaration of Conformity
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Major Aspects of the MDR
Below you will find a collection of important aspects under the Medical Devices Regulation (EU) 2017/745 (MDR) including short explanations and links towards graphics, downloads, previews on documents etc. If there is anything we can help you with please don’t hesitate to contact us!
Conformity Assessment Routes under the MDR
To give you a full overview of all conformity assessment procedures and routes that are available depending on the risk class of your device, mdi Europa has prepared several charts.
Classification Rules under the MDR
The MDR introduces new and amended classification rules. Manufacturers of certain devices might see their products falling into higher risk classes than under the MDD. For example, lubricating and ultrasound gels (class I under the MDD) will at least fall into class IIa.
We provide our customers with all the required information and guidance. To get a glimpse at some of the documents, please use the following link(s). For further information, please get in touch with our team.
Technical Documentation under the MDR
Technical Documentation requirements under the MDR follow a certain pattern. mdi Europa set up a checklist and template to assist manufacturers in the compilation of their Technical Files. You are also invited to make use of our extensive expert network should you require in-depth support. Please get in touch for further information!
General Safety and Performance Requirements
The SPR under the MDR include many aspects that must be carefully considered. mdi Europa set up a checklist that will help manufacturers to comply with the MDR. Please get in touch for further information!
Top-Level Guidance from European Institutions
European institutions published a number of top-level documents to support the MDR transition process, e.g. a Factsheet for Manufacturers, an Implementation Model for the Medical Devices Regulation and a document on the Implementation of Medical Devices EU-Regulation – Focus on Manufacturer’s obligations.
We provide our customers with all the required information and guidance. To get a glimpse at some of the documents, please use the following link(s). You are also invited to make use of our extensive expert network should you require in-depth support. For more information, please get in touch with our team.
Unique Device Identification (UDI) under the MDR
Under the MDR regime, each manufacturer is obliged to implement a UDI system. The Basic UDI-DI must be included in the Technical Documentation, Declaration of Conformity and Notified Body certificate. Basic UDI-DI and UDI-DI will be used for the registration in EUDAMED. In addition, the UDI has to be reflected on the labeling.
The European Commission and Medical Device Coordination Group (MDCG) issued some guidance documents, e.g. on Basic UDI-DI and UDI-DI attributes, on Basic UDI-DI and UDI-DI Changes and on UDI Core Elements .
You may find these and other useful documents and links in our Library section. You are also invited to make use of our extensive expert network should you require in-depth support. Please get in touch for further information!
Under the MDR, EUDAMED serves as a central database for the registration of economic operators and products, but also for vigilance reporting and clinical investigations. It is vital to choose the right partner to comply with the corresponding requirements.
Clinical Evaluation under the MDR
A major challenge of the MDR refers to the updated requirements on clinical evaluation. An effective way to prepare your documents according to the MDR provisions is to use the MEDDEV guidance document on clinical evaluations, MEDDEV 2.7/1, rev. 4.
You may find these and other useful documents and links in our Library section. mdi Europa has also set up a template to support your clinical evaluation process. Please use the following links or get in touch with us for further assistance.
Post-Market Surveillance under the MDR
PMS and in this context, Post-Market Clinical Follow-Up (PMCF), is assigned an important role under the MDR. Post-market data must be used to update essential documents, e.g. risk management and clinical evaluation.
Manufacturers are required to produce the corresponding documents in accordance with the MDR, e.g. the PMS Plan and Report/ Periodic Safety Update Report (PSUR) and the PMCF Plan and Evaluation Report.
mdi Europa may provide valuable assistance on these points.