Eudamed “Medical device regulation” Why Worry?
The regulations are in place, the EC is preparing MDR Eudamed, and the go-live deadline is March 2020. The EC reports that everything is under control, so why should manufacturers, distributors and importers worry?
If you are a manufacturer of medical devices and you wish to sell those products with the required CE mark in the EU and the EFTA countries then you must register with Eudamed, then pass Competent Authority validation and then provide your device-specific data to MDR Eudamed. Non-EU organisations are required to have an active mandate with an authorised representative. No need to worry? How difficult can Eudamed be?
The EC is now moving from Directives to Regulations. To avoid market disruption there will be some transition periods. The EC is currently preparing a new version of Eudamed, the medical device database, due for release in 2020. After go-live and in some cases during a transition period, Eudamed has to be populated with your data.
For medical devices (MDs) the transition period will end on 26 May 2020, the “Date of Application” (DoA) of the MDR. For in vitro diagnostic devices (IVDs) the transition period will end on 26 May 2022, the DoA of the IVDR.
Important Eudamed dates:
- Eudamed go-live is 26th March 2020.
- Organisations will be required to enter new or modified data for medical devices from 26th May 2020 and for IVDR from May 26th 2022.
- During the following 18-month period, after the date of application of Eudamed, the Eudamed database must be populated with all data on the rest of the devices placed in the European market.
Eudamed, how difficult can it be?
The medical device economic operators (EOs) must comply with the timelines above; in effect, these are the deadlines. Failure to meet the deadlines will affect the ability for EOs to sell CE-marked products in Europe. However, what do you need to do prior to this deadline? This is a very simple question to answer; you must prepare your data for inclusion in the Eudamed database. You must plan for how you are going to interact with Eudamed. EOs (manufacturers, distributors, importers, etc.) must comply. Eudamed will require all the UDI information, certificates, MIR forms for serious adverse events and much, much more.
Difficult? Why worry? If you have not started to prepare for this IT project, if you have not foreseen user training, and if you are not getting ready to provide the required data and then you could have a problem.
The level of data required by Eudamed, its complexity, the preparation time, and the level of user-required training is not be underestimated. Many companies and consultants are talking about the regulations, in particular the amount of work and rules they introduce. However, most companies – because of a lack of understanding – only give Eudamed a small mention e.g. “Requirements for EUDAMED database interaction” preferring instead to concentrate on QMS requirements, labelling requirements, UDI, and various, new authorised representative and product-liability rules. In truth Eudamed is a very complex, data-hungry application, which will require planning, not only on what data to provide but also on how to provide it, as there are a few different ways to supply the data. This data will also need to meet very complex XSD and business rules that again are complex and time consuming; this is an IT project that needs to be planned.
What should we plan for?
Eudamed and its required data is part of the regulatory requirements. This fact cannot be avoided. Eudamed has to be populated with your device data, your UDIs, packaging, OEMs, and much more. Organisations affected must plan for this. Decisions have to be taken as to how you will populate the databases, manually or automatically.
Your organisation must plan for Eudamed registration, which will involve your Competent Authority validating your application request. They will validate your company is correct and that your provided data is accurate. After validation, your organisation will need to add and manage your users. How many staff will have access? What access should they have? Will they be adding, editing, uploading, and versioning your organisation’s data?
Next, you will need to decide on your plans to provide the data to Eudamed: manually, XML upload, and machine to machine (M2M). Each choice brings more questions. Manual entry will require user training, XML upload will require a project to prepare your data and provide it in EC-compliant XML and then there is M2M. M2M will use an AS4-protocol-based system for direct data transfer from your database to Eudamed. This is the most complex option and, as with the XML preparation, it will require planning and project management.
There is a shortage of IT people with the necessary skill sets on the open market. Even if you have in-house IT personnel, do they have the necessary skill? You can decide to tackle all this work within your own organisation, within your own teams, but that may result in a steep and expensive learning curve for your organisation. Regardless, you need to plan and start on this as soon as possible. Eudamed is very complex. The XML schemas, XSDs and dozens of business rules, the specific data formats, the difficulties in using the application, and the AS4 eDelivery access points for M2M delivery; these are all very complex issues that have to be addressed.
So in answer to the original question, Why should you worry? If you have not planned, if you do not have access to IT people with the required knowledge and, even worse, if you have not even thought about this project because the deadlines are so far away, then you need to start fast. This is a major project and one that could affect your revenue if you get it wrong.
Eudamed.eu is an organisation that can help. We have the system knowledge, we have the experience and we have the ability to take care of all aspects of your regulatory compliance with Eudamed. From training, to support, to data preparation, validation and conversion, to uploading your data (machine to machine) to MDR Eudamed. Outsourcing this project is far more cost effective then taking it in-house, the learning curve could cost you months of a development team’s time.
Regardless of using our services or going it alone, you must start planning this project as soon as possible; it is not a small one. Incidentally, we can still provide you with ongoing support to help you with an in-house project or in using the application.