You already have your device on the US market and you want to enter the EU market. Good idea, but here are some things to take into account.
European Authorized Representative
Every legal manufacturer that is located outside the EU, needs to have a European Authorized Representative (or in short, EC Rep) that will be the main point of contact with the European authorities. The EC Rep has to be located within the EU and has to be mentioned on the device labels as well.
As well as being the liaison between you and the Competent Authorities (Ministries of Health), the EC Rep can assist you with certain local registrations. The EC Rep has to maintain an up to date version of the Technical File (for inspection by competent authorities) and they can assist you with Incident and Field Safety Corrective Action reporting. All of this is should be defined in an agreement.
As an EC Rep you can choose a subsidiary of your company, one of your distributors or an independent organization to act for you.
Under the MDR, for which the transition period ends 26th of May 2020, the responsibilities of the EC Rep will be increased (see further down).
When you already have a device on the US market, you are familiar with terms like Device History File (DHF) and Device Master Record (DMR).
For CE marking, you'll need to present a Technical File to either the Competent Authority or a Notified Body. This file includes items from the DHF and the DMR as well as additional documents to show compliance with the European legislation.
Besides specific documents, like the Essential Requirements Checklist and the classification of your device, it also contains information on the design process, design verification and design validation (from the DHF), your manufacturing process, manufacturing controls, packaging and labeling (from the DMR).
One part which is particular for the Technical File is the clinical evaluation report. This report does not only contain pre-market clinical investigation results but also post-market clinical follow up results. More information can be found in the MEDDEV 2.7/1 revision 4.
Legislation is changing
As mentioned before in this article, the European legislation is changing. No minor cosmetic changes, but big changes that have a serious impact on the European medical device industry.
Even though there are attempts to provide information, there is now, one year before the end of the transition period, still a lot of uncertainty and confusion.
On this webpage, the European Commission gives a (very) short introduction to the changes in legislation.
Depending on the nature of your device, the differences between the MDD (current legislation) and the MDR (future legislation) will be significant or very significant.
Not only product-specific requirements are changing, also on a more organizational level, there are significant differences.
- The responsibilities of the different economic operators (manufacturer, authorized representative, importer and distributor) are changing. Find out more in this factsheet published by the European Commission.
- You will need to have a person responsible for regulatory compliance with the right credentials. This is a new role that is coming with the MDR. Not only the manufacturer but also the EC Rep will need to have a person with this role available.
- Unique Device Identification: both US as well as EU are striving to have a harmonized way of labeling devices to make traceability easier and more transparent. Unfortunately, systems in both markets are not identical. More information on the UDI requirements in Europe, the similarities and the differences with the US, can be found here. Europe will be implement the UDI system with the new EUDAMED system.
- Harmonized Standards: This is not directly linked to the changes from MDD to MDR, but still there can be differences between the recognized standards by FDA and the Harmonized Standards that can be used to show conformity with the essential requirements in Europe. One example is the difference between ISO 14971:2007 and EN ISO 14971:2012. The content is the same, but the differences are in the Annex Z. Even though they seem to be hidden in the Annex, they do make a difference. An overview can be found here.
Another important consequence of the changing legislation is the strongly reduced number of Notified Bodies and their availability.
It is essential to start preparing as soon as possible.
It's not only the MDR...
It's obvious that the MDR is a key legislation to look at when you want to put a medical device on the European market.
But it's not the only regulation that is applicable.
Investigate which other directives or regulations might be relevant, for example:
- General Data Protection Regulation
- Registration, Evaluation, Authorization and Restriction of Chemicals (REACH)
- Waste Electrical and Electronic Equipment (WEEE)
- Restriction of Hazardous Substances Directive (RoHS)
Prepare for the future
Knowing that the transition period ends in less than a year, the focus should be on the new MDR.
First. evaluate your classification under the MDR and look at what is required.
Second, make a gap analysis between your existing documentation and what is expected under the MDR and other regulations and directives.
Lastely make sure to include the necessary resources (EC Rep, responsible person, Notified Body, etc) in process.
Many markets require their own registration file, including medical device files which contain similar information. If you are still working with documents in binders, you might find it useful to convert to a software tool that helps you generate different documents based on a central database of information for your device.
Don't hesitate to contact us for more information!