Are you ready for MDR 2017/745?
What is the Medical Devices Regulation?
What are the differences with the directive MDD?
How much time will I have to adapt?
How can I train my employees?
We can give you clear and effective answers.
WHAT DOES THE NEW REGULATION MEAN?
After five years of discussions, the European Parliament has approved the texts of the new regulations which, inter alia, repeal the historic EC Directive 93/42 on medical devices. From this link you can download the full text in English of the REGULATION (EU) 2017/745.
The placing on the market of the devices will therefore have to meet the requirements of the new MDR (Medical Device Regulation), the transition period will last 3 years. The new regulation takes into account the specificity of the medical device, the stricter controls are combined with the need to protect the speed of innovation in its access to the market.
A number of important innovations are therefore introduced:
Eumed can support you in the gap analysis, implementation and training phases necessary to ensure your company's full legislative compliance.
Eumed consultants are available to analyze, even by video conference, your particular situation and to draw up an adaptation plan for your company in real time.
THE CURRENT SITUATION
On Friday 17 April, during the plenary session, Parliament decided to approve the European Commission's proposal to postpone the application of the 2017/745 Medical Device Regulation for one year, postponing it to 26 May 2021. The choice was made to allow competent authorities and manufacturers to concentrate their efforts in the fight against COVID-19 and to avoid a lack of stocks or delays in the production of essential medical devices on the market. The proposal will now have to be approved by the Member States and will be published in the Official Journal (GUCE) before the date of application of Regulation 745, which was scheduled for May 26, 2020.
The extension does not concern Regulation 2017/746 on in vitro diagnostic medical devices, whose application remains scheduled for May 26 2022.
Thursday 23 April 2020 the European Council approved and made official the one-year extension of Regulation on medical devices. Regulation 2020/561 relating to the new dates of application of the provisions of Regulation 2017/745 has been published in the OJEC.
EUDAMED - Actor Registration Module
On 20th of October 2020 the EU Commission published online the new webpage dedicated to the Action Registrarion Module in Eudamed (link).
Manufacturers, both EU and non-EU, importers, authorized rapresentatives, sistem and procedure pack producers, have to register in this new database, which is planned to be functional by december 2020.
--> 1° December 2020
THE NEW ACTOR REGISTRATION MODULE (EUDAMED) IS NOW AVAILABLE!
The EU Commission has made available the actor registron test module.
If you are:
- EU or extra-EU manufacturer
- system/procedure pack producer
- authrized representative
You can create your EU login account and register in Eudamed: after the national competent authority has approved your request, you will receive your SRN (single registration number) ad economic operator.
You will be able to manage your account and users and to test the module before it will be definitely operational.
Currently Notified bodies designated for Regulation 2017/745 :
It is expected the first draft of common specifications.
Economic operators have to obtain a single registration number (SRN), generated through the Eudamed registration module and issued by the competent national authorities. An SRN must be requested for each role covered (e.g. 1 SRN as manufacturer and 1 SRN as importer): the SRN will be the access key of each operator to Eudamed.
One of the problems related to Eudamed concerns the access mode, provided through the UDI code. However, the so-called legacy devices (devices that can be marketed pursuant to certificates of conformity to the 93/42 / CEE and 90/385 / CEE Directives that are still valid) are not subject to the UDI obligation, which is why to allow the registration of these devices two different unique "keys" have been announced for access to the database (IDs): the Eudamed DI (corresponding to the basic UDI-DI) and the Eudamed ID (corresponding to the UDI-DI).
REPROCESSING OF SINGLE-USE DEVICESOn August 19th the Commission implementing REGULATION (EU) 2020/1207 has been published, as required by article 17 of Regulation (EU) 2017/745 (par. 5). This regulation contains the common specifications (SC) for the reprocessing of single-use devices.
On the Commission's website there is the Topics of interest section where you can find updates on:
1. Notified bodies,
2. Eudamed and UDI,
3. Software and apps,
4. In-house medical device,
5. Customized devices,
7. Innovative Medicines Initiative (IMI),
On the Guidance page you will find all the documents published by the MDCG group to support stakeholders in the application of the Regulation.
For updates on the European database, consult the dedicated EUDAMED page.