The new MDR (EU) 2017/745 entered into force on May 26, 2017 by repealing the Directives 90/385/EEC (AIMDD) and 93/42/EEC (MDD).
Before discovering all the most relevant features of the MDR Medical Devices Regulation 2017/745, we remember the most important deadlines.
- The MDR 2017/745 full application date was recently extended to May 26, 2021 due to the Coronavirus emergency.
- From May 27, 2024 all the MDD/AIMDD Certificates will lose validity and the MDR 2027/745 will enter into force for the class I Medical Devices requiring a Notified Body.
- From May 27, 2025, the devices released in accordance with the MDD/AIMDD will no longer be made available on the market.
Therefore, this is the right time to address in time the new and more restrictive obligations of the MDR 2017/745 Medical Devices Regulation.
As it will become clearer in this article, it is necessary to organize now in order to implement in time the new necessary processes, to increase and qualify the staff company appointed to the MDR Certification and eventually, to establish a relationship with strategic consultants specialized in EC Certification.
Why the MDR 2017/745?
Both the Council and the European Parliament highlight the need to adapt the legislation on Medical Devices to the needs of the future in such a way as to provide an appropriate, robust, transparent and sustainable regulatory framework.
That’s why the MDR 2017/745 Medical Devices Regulation does not simply supplements previous Directives with amendments, but it was created as a real new Certification that provides for much stricter requirements and measures more in line with the evolution of the global medical device market.
Specifically, here are some of the most important objectives of the new MDR 2017/745:
- To resolve differences in the various national regulatory systems between the different EU member States;
- To strengthen the monitoring of holdings by the Notified Bodies;
- To strengthen the post-market surveillance
- To better identify and trace Medical Devices;
- To cope with the need to quickly market the most innovative products that use hybrid technologies.
MDR 2017/745: everything more complicated
The new MDR 2017/745 Medical Devices Regulation contains many novelties and at the same time inconsistencies and gaps which make its implementation particularly complex.
Firstly, the requirements content in the MDR are more than those content in the MDD and they concern both the product and the quality system.
Moreover, implementing requirements requires much more evidence and technical documentation.
Consequently, in the implementation of the MDR 2017/745 Medical Devices Regulation, they will inevitably be favoured large organisations that can invest in the strengthening and training of human resources and that have the ability to handle complex amendments, possibly with the help of strategic consultants outside the company.
The main innovations of the EU Regulation 2017/745
- New and stricter classification rules for Medical Devices and modification of same MDD rules.
- Definition of the role and responsibilities of the Economic Operators involved in the import and distribution of Medical Devices: Manufacturer, Authorised Representative, Importer and Distributor. For each of these subjects are provided specific requirements.
- Obligation in the companies of Medical Devices of the Person Responsible for compliance with the MDR 2017/745 Medical Devices Regulation. The Person Responsible shell: control the conformity of the device according to the Company Quality System before the device is released, verify that the technical documentation and the declaration of conformity are present and updated, ensure that post-market surveillance requirements and reporting requirements are met. Very important: the Person Responsible must possess the essential requirements that certify specific competences on the EU 2017/745 Regulation.
- Greater importance to Clinical Evaluation.
- Stricter post-market surveillance and vigilance.
- More technical documentation to be produced.
- Device traceability with the creation of the UDI (Unique Device Identification) system.
- Use of EUDAMED to collect device information in a single European database.
- Simplification of conformity assessment procedures.
5 tips to prepare for the new MDR (EU) 2017/745 Regulation
- Select the list of Medical Devices, eliminating what represents a dispersion of resources and does not allow to re-enter the investment.
- Consider longer times for the time to market of new and modified Medical Devices.
- Strengthen the Quality/Regulatory Affairs function and determine who can play the role of Responsible Person in the company.
- Involve all the business functions in the implementation of competence requirements(e.g. PMS).
- Rely on expert consultants able to guide company strategy and to plan the necessary actions, optimizing time and costs, avoiding mistakes or to delay its presence on European markets. Thema offers strategic-regulatory consulting services and CE certification support of Medical Devices and IVD. Thema strategic consultants are ready to support companies in the process of adapting to the new MDR 2017/745 Medical Devices Regulation.
To know what we can do for your Company, contact us! firstname.lastname@example.org
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