European trade association, MedTech Europe, published a detailed plan.
It aims to help the member states speed up and simplify the process of implementation of new MDR/IVDR regulations.
The plan intends to assist states and national medical regulating authorities by discussing conditions necessary to pass to the new regulatory framework set forth by new medical devices and in vitro diagnostic regulations.
Key points of the MedTech implementation plan.
The guidance, which is published by associations representing diagnostic and medical devices manufacturers in Europe, contains several steps with detailed recommendations on each particular aspect of implementation process.
The list includes, among other, the following steps:
- Accelerated designation of notified bodies (NB),
- Deployment of the Eudamed,
- Development of guidance,
- Formation of expert bodies (panels).
Implementation steps in details
Notified bodies are special organizations designated by each EU member states to conduct the conformity assessment of medical devices prior to the marketing submission.
NBs are intended to provide transparent conformity assessment services to manufacturers within the EU territory or outside and transfer the information to the regulating authorities.
This procedure could potentially simplify the reviewing process for the new marketing submissions.
There are only two NBs already appointed at the moment, so it is necessary to accelerate the designation. Otherwise it could cause issues related to re-certification due to the changes of regulations in accordance with the implementation of MDR/IVDR.
That is why numerous NBs should be designated to deal with the upcoming re-certification of medical devices, which would cover almost all types and classes.
The availability of medical devices on the market would depend entirely on the designation of notified bodies and the efficiency of their performance.
Eudamed is the European Databank on Medical Devices. According to the regulations, the database would store information on:
- medical devices, including their Unique Device Identifiers (USIs),
- clinical trials and investigations including performance studies for IVDs,
- manufacturers and importers of medical devices, including their Single Registration Numbers (SRNs),
- market and post-market surveillance data,
- information on accreditation and designation of NBs,
- applications for conformity assessment,
- information on safety and performance.
Main parties involved in regulatory process, such as the national regulating authorities, European Commissions, Notified Bodies, manufacturers and importers, will have access to the database. The deployment of the Eudamed could improve and simplify the exchange with the information between parties and make the regulatory process more transparent.
It is also necessary to develop regulatory guidance for the most innovative field like software (SaMD) or entirely new devices that have not been in the market before.
Additional clarification of such issues would improve the regulatory framework in general and create favourable conditions for the companies specializing at medical innovations.
Formation of expert panels would help to focus regulatory efforts on the most important issues to ensure that most important devices get priority reviews and become available in the market as soon as possible.
In general, the recommendations issued by MedTech Europe cover the most important regulatory issues related to the medical devices. The adoption of these recommendations could substantially accelerate the implementation of MDR/IVDR.