MEDICAL DEVICES REGULATION (MDR)

07/05/20

Information on the European Union's Medical Device Regulation

As you are probably aware, the European Union implemented in 2017 a Regulation relating to Medical Devices, the Regulation (EU) 2017/745, which have many impacts in particular on the industry of the sector.


We would like to provide you with some information on this subject and to assure you that Didactic remains committed to providing you with all the assistance you consider necessary in this transition.

Context

The Regulation 2017/745, adopted in May 2017, will replace the existing Directive relating to Medical Devices (93/42 / EC as amended by Directive 2007/47 / EC).

The Regulation is a response to recent concerns regarding the evaluation of product safety and performance and imposes more stringent requirements for clinical evaluation and post-market clinical follow-up. In addition, the Regulation requires better traceability of devices throughout their life cycle, in particular through two flagship tools: the Unique Device Identifier (UDI) and the introduction of a centralized European Medical Devices database called EUDAMED.

Beyond the new constraints or rules introduced by this new regulation, it is important to keep in mind that it will above all, ensure greater security and better protection for patients and users.

 

Consequences and Deadlines

Unlike the previous Directive, the Regulation is applicable in the same way in all the Member States of the European Union without transition into local law, therefore without difference of interpretation.


Initially, Regulation 2017/745 was scheduled for implementation on May 26, 2020.

Following the covid-19 pandemic, the European Commission has adopted the proposal to postpone one year, the date of application of Regulation 2017/745.

The following milestones are thus defined:

  • As of May 26, 2021, the first products to comply with the Regulations begin to be marketed
  • From May 27, 2026, only products that comply with the Regulations can be marketed

This means that Medical Devices complying with the Directive can coexist with Medical Devices complying with the Regulation, until this second deadline. It is therefore very important to note that during this period, products that comply with the Directive will remain fully authorized throughout the validity of their CE certificate.

Responsibilities of our distributors

In accordance with article 14 of the Regulation, new responsibilities are imposed on distributors in order to consolidate post-market surveillance.


Distributors will have to organize themselves to meet the requirements with procedures, to control the devices, verify information provided, communicate with economic operators and competent authorities, manage non-compliant devices and materiovigilance.


Didactic will be available to assist you in the implementation of all actions to meet these requirements with dedicated regulatory support. It is important to note that as a distributor, you will have to respect these obligations in any event.

Didactic's situation

Since the publication of the Regulations in 2017, we have been working on the implementation of the new requirements. Indeed, we consider this regulation as an opportunity to extend and even share with our partners our experience and our expertise in the control of our subcontractors, suppliers, and of course our productions.

The situation of all of our subcontractors has been assessed and additional actions have been implemented, if necessary, to ensure continuity of production in accordance with applicable regulations. We have also implemented actions in terms of management of our stocks in order to avoid any shortage in our supply chains during the transitional phases of application of the Regulation.

Our CE technical files are also updated according to the new requirements of the regulation and will be ready to be audited by our Notified Body within the required deadlines.

In conclusion, we confirm that Didactic team are mobilized to limit as much as possible the possible impacts for all of our partners, in particular professionals and healthcare establishments, and guarantee uninterrupted supply.


And if you have any questions about it, contact us!


The Regulatory Affairs team