The European medical device industry will undergo significant changes as a result of the new in-vitro diagnostic regulation which has signed on May 26th, 2017. As the name suggests, is it a regulation and no longer a directive and all in-vitro diagnostic companies that sell medical products in Europe have to adhere to this new regulation.
Companies that do not follow this regulation will no longer be allowed to sell their medical products in the European Union after May 26th, 2022. Depending on your role as economic operator (manufacturer, importer, authorized representative, distributor) the impact can be meaningful.
Below you will find a step-by-step implementation guide with regards to the new in-vitro diagnostic regulation (MDR EU2017/746). Our guide is simple to understand and will allow you to save time and money when implementing the new regulation.
(Note: This guide should not be considered as a recommendation, it’s just based on our own experiences.)
Will your Notified Body be certified by IVDR and your product categories are covered in their scope?
Yes: Save your IVDR audit date!
No: Change your Notified Body as soon as possible!!!
Check if the new IVDR rules have any impact on the classification of the existing or future products. The classification rules are defined in Annex VIII.
Depending on your business you have one or multiple economic operator responsibilities, which is imperative to know before you start with the gap assessment. Economic operators are Manufacturers, Importers, Distributors or Authorized Representative. Each of them has different requirements to fulfill the IVDR.
Reduce not required information by going through the chapters and annexes and eliminate all not required information.
Define keywords which are not applicable to you. In our IVDR tool you have the opportunity to search for these keywords.
Go through all open requirements step by step and define if requirements are relevant for your business or not.
With our IVDR Gap-Analysis Tool you are able to do all these steps above and you can reduce the information immediately.
We also can help you through the first steps with our IVDR STARTING PACKAGE. We show you how our tool works, give you some extra helpful documents which are not available on our page. These extra checklists and tips will speed your IVDR project dramatically.
Prior to starting the implementation phase, you should put a plan in place. The steps below will guide you through the main topics.
4.1 Safety and performance checklist:
Create a General Safety and Performance document according to the IVDR requirements in annex I.
4.2 Technical File:
Technical file update according to Annex II and III.
4.3 Risk management according to ISO 14971:
Your risk management activities (plan, analysis, and report) should be aligned with your PMS and PMPF activities.
4.4 UDI System:
Each medical device needs a UDI-DI (Unique Device Identification – Device Identifier) and UDI-PI (Unique Device Identification – Production Identifier) and must be submitted and transferred to the UDI database. (See document from the EU Commission).
4.5 Post Market Surveillance (PMS):
Post market surveillance is defined in chapter VII of the IVDR.
4.6 Post Market Performance Follow-Up (PMPF):
Manufacturers shall conduct a performance evaluation in accordance with the requirements set out in Article 56 and Annex XIII, including a PMPF.
4.7 Performance Evaluation Report (PER):
Create a performance evaluation report (PER) according to Annex XIII.
Manufacturers shall ensure that the device is accompanied by the information set out in Section 20 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.
4.9 EUDAMED registration:
Currently, the EUDAMED is not online but a first FUNCTIONAL SPECIFICATION version is available. The initial release was March 2020, but the European Commission has decided change the initial release up to May 2022 (see decision letter). Any changes to the release date will be communicated with our Regulatory Intelligence Paper.
4.10 Common Specifications:
Take care about upcoming specification updates. We keep you informed with our Regulatory Intelligence Paper. Furthermore, this paper helps to address regulatory activities according to ISO 13485:2016, Chapter 5.6 Management Review.
Performing internal audits and a final mock audit to ensure the key requirements have been implemented.
The Final checklist will ensure the completeness of your implementation process.