Specculo’s Import Assist allows for organisations placing medical devices on the EU market to outsource certain obligations incumbent on them as indicated in the EU Regulations 2017/745 and 2017/746. We understand that some of the obligations and requirements applicable to importers can be, to say the least, tedious to manage.
Since Specculo works to put technical documentation together for the EU, we are in a good position to review and verify that the documentation and information you receive from the legal manufacturer is appropriate and conforms with EU legislation and industry best practices.
We help importers by providing the following services:
- Documentation Verification.
- Label/IFU/Packaging Verification.
- Vigilance Guidance and Assistance.
- Eudamed Verification.
- UDI Verification.
- General Consulting on Other Obligations.
- Importer Contract/Agreement Template.
- QMS Consulting.
Read our in-depth article on the obligations of importers of medical devices and IVDs on the EU market, here.
All necessary technical documentation will be verified accordingly. This mainly involves the review and verification of the EU Declaration of Conformity to ensure it has been drawn up in accordance with the EU requirements. There are several key elements of the Declaration of Conformity which should be indicated on the document.
If your organisation asks for additional documentation to be provided, e.g. a Device Description or Classification Rationale document, these may also be reviewed for correctness.
Information Provided by the Manufacturer
It is vital that medical devices being made available to the end user be fully compliant with the EU Regulations. Our team will verify that the following have been drawn up correctly:
- Instructions for Use.
- Marketing Material.
We specifically check the device labels and IFU for conformity with the Annex I General Safety and Performance Requirements, ensure that the Legal Manufacturer, EU Authorised Representative, and Importer have been clearly identified, and verify that the CE mark has been affixed accordingly.
As part of our package, we provide guidance on how to report incidents, handle Field Safety Corrective Actions (FSCA), and communicate with EU Competent Authorities.
Alternatively, we can also assist your organisation in submitting vigilance reports. Our standard hourly fee would apply.
Eudamed and UDI Verification
Although not currently mandatory, medical devices and IVDs will need to be registered on Eudamed. If you haven’t done so already, we can submit an Economic Operator registration application through Eudamed in order for you to acquire a Single Registration Number (SRN).
Furthermore, we can verify whether a device UDI-DI has been duly and appropriately registered on Eudamed.
Our Import Assist package includes a 30 minute consultation every month. This covers any regulatory-related queries you may have, which may be answered through a call or email.
The Import Assist Package includes a template which can be used as a good basis on which to build your agreement or contract with the manufacturer. As a minimum, it includes the obligations of both the manufacturer and the importer, as detailed in the EU Regulations.
Alternatively, you can ask Specculo to review your existing agreement to ensure that this does not contradict the EU Regulations and includes all relevant obligations.
Quality Management System
Whether large or small, setting up a Quality Management System (QMS) is the recommended approach for importers to ensure they continually meet their obligations before, during, and after having placed devices on the market. Specculo offers various services which may be added to your Import Assist Package, including the setup or amendment of your existing QMS or performing an internal audit on scheduled dates.
Ensuring that your personnel are knowledgeable about importer obligations under the EU Regulations is a vital step in maintaining compliance. We offer robust importer training sessions to get your organisation up to speed with the Regulation requirements and industry best practices.
Import Assist Package
The Import Assist Package includes the following services as part of an annual subscription:
- 30 minute consultation per month.
- Declaration of Conformity Verification.
- Label, IFU, and Packaging Verification (once per product group).
- Vigilance Guidance.
- Eudamed Verifications.
- Importer Agreement / Contract Review.
Free templates for:
- Importer Agreement / Contract with the Legal Manufacturer.
- Vigilance Procedure.
What you get with Specculo
We have years of experience in handling large and small projects alike on a vast range of medical devices and IVD technology.