Commission Addresses Non-EU/EEA Authorities To Set Record Straight On New EU Regs

There are fears that some countries may reject medical devices and IVDs that have been CE marked under the EU medical device directives, even though their registrations may still be valid. The European Commission is now trying to address this.

Much concern has been voiced in the medtech sector about the possbility for some non-EU or non-European Economic Area member countries to remain unaware of the ongoing validity status of certain medical devices and IVDs that have been CE marked under the three current EU medical device directives. This relates specifically those products whose registrations may continue to be considered valid in the EU even after the respective May 26, 2020 and May 26 2022 deadlines for the Medical Device and IVD Regulations.

Ongoing validity of these registrations would be possible due to the extension period that has been written into the two Regulations. The EU medtech sector is generaly well acquainted with this aspect of the Regulations, in all their complexity, but other countries may not be as up-to-speed as they should be. 

For this reason, the European Commission has issued a factsheet to educate those authorities who may not be informed about the basic point:  that some devices with certificates issued under the directives may continue to be placed on the market until May 27, 2024 and be made available until May 27, 2025.

Highlighted in a red box in the center of its new factsheet, the Commission writes:

"Until May 2025, products certified under the Directives and products certified under the Regulations will coexist on the market. Both will have equal status under the legislation, and no discrimination in public tenders may take place." This is provided that they are accompanied by appropriate certificates.

Commission Tells Non-EU/EEA Manufacturers To Act Too

The Commission is now telling third countries how they should act to support imports and exports of medical devices. It says:

• "As an authority in third countries that export devices to the EU, you may receive requests for information from manufacturers in your country wishing to place devices on the EU market. You should make your manufacturers, national associations and chambers of commerce aware of the new rules, timelines and obligations under the new Regulations. Refer them to the website of the European Commission or the authorities’ contact points for further information on the application of the Regulations or for guidance;" and 

• "As an authority in third countries that import devices from the EU, you need to be informed about the timelines for implementing the Regulations and to bear in mind that MDD- or IVDD-compliant products are likely be on your markets after the date of application of the Regulations. To avoid disruptions on your market you should inform your health institutions, procurement bodies, customs officers and importers about the new requirements and the applicable timelines, and clarify the various transition provisions regarding, for example, the reclassification of products to higher risk classes or labelling requirements."

Two More Recent Factsheets

This is one of three new factsheets issued by the European Commission very recently. The other two are:

Factsheet for Authorised Representatives, Importers and distributors of Medical Device and IVD Medical Devices

Factsheet for the Procurement Ecosystem of Medical Devices and IVDs.

The document on procurement reiterates what is said in the factsheet intended for non-EU/EEA authorities in terms of products certified under the Directives and products certified under the Regulations coexisting on the market until May 2025: it stresses that both registration types will have equal status under the legislation, and that no discrimination in public tenders may take place.

These factsheets are part of a growing series of documents that have been drafted by the European Commission to explain, at a high level, the impact of the implementation of the new MDR and IVDR. They are an attempt to make a complex process more straightforward (even if locating the documents on the European Commission's website cannot really be decribed as such).