How do I get a medical device approved in the EU?

How do I get a medical device approved in the EU?

In order to commercialize medical devices in the European Union, a CE Mark certificate is needed. This certification verifies that a device meets all regulatory requirements of the Medical Devices Directive (MDD), or Active Implantable Medical Device Directive (AIMD) as they apply to your product.

How long does MDR approval take?

Once approval has been secured from a notified body, a CE marking can be affixed to the certified product, which means it can be placed in the EEA. While this is the final step in demonstrating compliance with the EU MDR, the process can take up to 14 months to complete from the initial submission to a notified body.

Is FDA approval required in Europe?

The FDA must approve all high-risk medical devices in the United States, but in Europe, some high-risk devices, such as those that are not intended for “distribution and/or use on the Community Market,” are not approved under the Medical Devices Directive.

How long does CE Mark approval take?

four to six weeks
On average, the CE marking process takes four to six weeks. It can also take longer or shorter depending on test results, whether the product still needs to be modified, and how quickly the technical documentation can be supplied. The CE marking process differs for every product.

How long does it take to get a CE mark medical device?

After you apply for a CE, the wait time is typically between 12 and 16 weeks. However, most Notified Bodies offer options for expedited reviews or even on-site review of your Design Dossier and Technical Files.

Is prefilled syringe A medical device?

Finished prefilled syringes require marketing authorization as a drug, in some regions as a combination product or as a medical device, depending on the content and the intended use. The syringe plays a dual role in the prefilled syringe product — as a container closure system and as a delivery device.

Where does EU MDR apply?

The EU MDR entered into application on 26 May 2021 If you are a manufacturer, authorised representative, importer or distributor of medical devices in the EU, or a regulatory affairs or quality management professional involved with medical devices, you need to know how to comply.

What is the difference between MDR and MDD?

The MDR is significantly more comprehensive and detailed compared to the MDD. While the MDD comprises 23 Articles and 12 annexes over 60 pages, the MDR has 123 articles and 17 annexes over 175 pages. The scope of the MDR is wider than that of the MDD.

What is the European equivalent of FDA?

European Medicines Agency (EMA)
European Medicines Agency (EMA) : The European Medicines Agency (EMA) is a decentralised body of the European Union, located in Amsterdam. Its main responsibility is the protection and promotion of public and animal health, through the evaluation and supervision of medicines for human and veterinary use.

Is CE better than FDA?

Still, while the CE mark is less onerous to obtain, it is a less powerful certification. FDA approval means that the device is approved for use in all parts of the world, while the CE mark has restrictions, sometimes even within the EU.

What is European CE?

The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements.

What is the European medical device regulation?

The European Medical Device Regulation (EU MDR) ensures high standards of quality and safety for medical devices being produced in or supplied into Europe.

What is an EU certification?

International operator. EU Certification operates throughout Europe and incorporates the legislative requirements of different countries as part of its certification process. This uniform certification indicates that the company fulfils the legislative criteria required in each country.

What is medical device regulation?

Medical Device Definition. Human drugs are regulated by FDA’s Center for Drug Evaluation and Research (CDER). Biological products which include blood and blood products, and blood banking equipment are regulated by FDA’s Center for Biologics Evaluation and Research (CBER). FDA’s Center for Veterinary Medicine