How long does it take to register my COVID-19 Medical Device/In vitro Diagnostic in Europe
The European Commission (EC) conducted a survey between 7 May to 13 May 2020 among the different Notified Bodies (NB) designated to carry out conformity assessments under the Medical Device and In Vitro Diagnostics Directives and Regulations.
The NB were asked to quantify the time required for the conformity assessment process for the various devices classes and procedures by which COVID-19-related medical devices can be placed on the market and for which the involvement of a NB is required.
As a reminder, the manufacturers willing to register Medical Devices (MD) or In Vitro Diagnostics (IVD) in Europe (COVID-19 related or not) should have their product CE-marked after performing a conformity assessment to confirm that they comply with the relevant legal requirements. In some instances, the manufacturer has to interact with the NB if the device falls into the following categories:
- Class I only if supplied sterile and/or with measuring function, Class IIa, IIb and III under Annex IX of the Medical Device Directive (MDD).
- Class I only if supplied sterile, with measuring function, and/or that are reusable surgical instruments, Class IIa, IIb and III under Annex VIII of the Medical Device Regulation (MDR).
- Devices for self-testing as defined in Article 1(2)(d) of the In Vitro Diagnostic Directive (IVDD) .
- IVD classified as Class A sterile, Class B, Class C and Class D under Annex VIII the In Vitro Diagnostic Regulation (IVDR).
Thirty-seven NBs, out of a total of fifty-five replied to the questionnaire and the results are presented in the following link:
The report includes data differentiating between:
- New MD/IVD product applications vs change on an already existing certificate.
- New NB client vs already existing NB client.
- MD and IVD classes.
- Different Directives and Regulations (MDD, MDR, IVDD, IVDR).
- Different conformity assessment routes.
It has to be highlighted that, for instance, 16% of NBs have stated that they are not taking any new applications for device certifications. Such percentage is reduced to 8% when considering applications related to a change notification.
Also, this survey reminds the limited number of NBs designated to perform activities under some conformity assessment routes (both under MDD and MDR) as well as a low number of NBs designated under MDR and IVDR. In addition, in the current COVID-19 context, the NBs will often not be able to carry out on-site audits.
According to this survey, these facts are likely to play a role/have an impact in the increased time for completion of these activities.
Please follow this link if you are looking for the list of designated notified bodies (NANDO information system).
Hereafter are specified the lists of NB under distinct EU legislation.
You are an MD/IVD manufacturer? One of your products is intended for COVID-19 diagnostic/treatment/prevention? You are encountering difficulties during your product registration? Send us an email at email@example.com. We are here to help!
Drug Development and Regulation (DDR) is an independent European consultancy company, focused in providing appropriate scientific & regulatory expertise for the global development and registration of Drugs and Medical Devices.
Our valuable and tailor-made solutions contribute to the success of your development programs from a quality, nonclinical, clinical, and regulatory point of view.
Advantageously located in Barcelona, Amsterdam & London, DDR also benefits from a large network of highly qualified experts and strategic collaborations with renowned institutions worldwide.