Short time to May 26, 2021 which is the date of full implementation of the Medical Devices Regulation MDR (EU) 2017/745.

If you are a Manufacturer, an Economic Operator or another interested party, you must take action as soon as possible to apply the requirements and be ready for the deadline.

To help you, here is a summary of the main changes.

What does the MDR (EU) 2017/745 entail?

In general, the Medical Devices Regulation maintains all the requirements of the previous Directives (AIMDD e MDD) adding new and stricter ones in line with the development of the global medical device market. It is however a real new Certification, seamlessly with the previous regulation.

Below the 9 most innovative topics of the MDR (EU) 2017/745.

1. More details on the Clinical Evaluation process, with the Post-market Clinical Follow-up applied throughout the life cycle of the device.
2. Need to perform a timely reclassification of devices.
3. New obligations and responsibilities for Economic Operators.
4. Stricter requirements for the designation of Notified Bodies and greater control and monitoring by the Competent Authorities and the European Commission.
5. Obligation to identify and empower the Person Responsible for compliance with the MDR (EU) 2017/745 Regulation.
6. Stricter Vigilance and Post-Market Surveillance (PMS).
7. Further definition of the Technical Documentation to be drawn up.
8. UDI system (unique device identification) to improve the traceability of Medical Devices.
9. EUDAMED: European database that collects in a single database the data of all Medical Devices and in Vitro Diagnostic Medical Devices.

MDR May 26, 2021: what challenges for Economic Operators?

We have seen that the MDR contains many novelties and that each Economic Operator must comply with it by May 26, 2021.

It should be known that not everything provided for in the MDR, for example the database EUDAMED, may be fully operational before the date of application.
Despite this, however, it is necessary to apply as much as possible and to foresee what is not yet present: it is good therefore to act now to be ready in time.

If you are a Manufacturer we suggest that you now prepare a MDR action plan to make sure that:

• all products are correctly classified;
• the intervention of a Notified Body can be arranged in time, if provided for, according to the expected workload on the Bodies themselves;
• all product documentation and conformity tests are present and adapted in compliance with the Medical Devices Regulation;
• Clinical Evaluation and Post-Market Surveillance processes are implemented and managed and the internal Quality Management System of the organization is aligned.

If you are an Authorized Representative, an Importer or a Distributor of Medical Devices, you can know in detail what are obligations and responsibilities provided in the MDR (EU) 2017/745 by downloading our White Paper on Economic Operators.

For more information on timeframes and operational advice, see also the MDR 2017/745 Medical Devices Regulation

Thema has the right solution for you!

Thema experts, through specific strategic-regulatory consultancy, can guide you on the most effective path to achieve compliance with the requirements of the MDR by May 26, 2021.

That’s what we can do for you!

• Feasibility analysis to verify the necessary requirements.
• Gap-analysis and documental pre-screening.
• Drawing up of product and system technical documentation.
• Drafting or updating of Clinical Evaluation Plan (CEP), Clinical Evaluation Report (CER) and Post-Market Clinical Follow up (PMCF).
• Labelling update (labels and instructions for use).
• Implementation of MDR requirements related to Post-Market Surveillance, market surveillance and vigilance.

Contact us for more information!

And it’s not all!
We remind you that Thema provides among its MDR services the quick solution for you toact independently starting from some strategic documents and thus have a very useful operating base to meet the main requirements of MDR.

“MDR Emergency Kit” is the digital package containing the basic technical and system documents, customizable and available for:

• Manufacturers.
• Authorized Representatives.
• Importers.
• Distributors.

See MDR Emergency Kit: the fastest solution for Economic Operators of Medical Devices.