Consultancy (Scientific Advice)

The Medical Devices Section of the State Institute for Drug Control (hereinafter referred to as “SÚKL”) provides upon request consultancy / Scientific Advice concerning procedural-regulatory issues and scientific requirements related to the regulation of medical devices.

Consultancy activities arising from the statutory remit of SÚKL are a paid service offered by SÚKL. There is no legal entitlement to such service and the decision whether the service will be provided is made solely by SÚKL on the basis of an individual assessment of the application.

When to apply for consultancy / Scientific Advice?

The Medical Devices Section of SÚKL provides consultancy on medical device regulation both in terms of procedural-regulatory and scientific point of view based on the applicable legal requirements for the regulation of medical devices.

Hereinafter, you can find examples of relevant areas for consultancy, as follows in a non-exhaustive list:

• the early stages of development of a particular device
• qualification and classification of medical devices
• clinical investigation and clinical evaluation of medical devices
• performance studies and evaluation concerning IVD
• post-market surveillance and vigilance obligations
• risk management plan
• borderline products.

Both a natural and a legal person can apply for consultancy / Scientific Advice.

The scope of the consultancy shall be determined subject to the list of clear and specific questions relating to the aforementioned procedural-regulatory and scientific areas, accompanied by duly substantiated proposals for their solution, which the applicant shall submit as part of the formal application. SÚKL does not provideconsultancy on planning, design and development of devices, nor general, broad, unspecified advice in lieu of a thorough study of the relevant legislation or on issues for which clear answers can be found in the relevant European or national legislation due to capacity reasons.

On the basis of the questions submitted by the applicant, supported, where appropriate, by the attached up-to-date documentation, SÚKL shall decide to what extent the requested advice will be provided. In case the scope of the questions falls under several agendas, SÚKL may propose to hold several consultancy / Scientific Advice sessions. Each such session will focus on a specific agenda issue.

How to apply for consultancy / Scientific Advice?

The Medical Devices Section of SÚKL provides only oral consultancy / Scientific Advice, either in person, via teleconference or in hybrid manner.

The application must always contain a list of clear and specific questions relating to the aforementioned procedural-regulatory and scientific areas, with well-reasoned proposals for their solution. In addition, the applicant is invited to submit up-to-date supporting documentation, including, where appropriate, a presentation relating to the issues raised.Detailed supporting documentation should always be submitted in advance, all in a clear arrangement. The extent of the documentation submitted should only remain within the scope of the necessary information required for the consultancy / Scientific Advice. SÚKL also recommends the duration of the consultancy meeting and its date(s) to be specified within the application.

The formal elements of the application for consultancy / Scientific Advice should include:

– clear and specific question(s) with duly substantiated proposals for addressing the issue(s) in question (along with supporting documentation where appropriate)

– number and names of participants

– the name, telephone number and e-mail address of the contact person

– the name, address and registration number of the company

The applicant fills in the required data in the application form and sendsit either electronically via e-mail to sys@sukl.cz or to the data box of SÚKL. Thereafter, the applicant will be contacted by the employee in charge of processing the consultancy / Scientific Advice (hereinafter referred to as the “consultant / contact person”), who will arrange a meeting date with the applicant and, based on the questions sent, will inform the applicant of the amount to be paid for the consultancy / Scientific Advice.

It is advisable to submit the application for consultancy / Scientific Advice with all relevant particulars to SÚKL well in advance of the proposed consultancy / Scientific Advice date.

The consultancy / Scientific Advice process

Assuming that the application is approved as a consultancy / Scientific Advice on the basis of the aforementioned application (validation) form, a 60-minute meeting of the applicant, his/her team and the designated SÚKL staff will take place, usually at the headquarters of SÚKL, or by teleconference or in hybrid manner at a mutually agreed date. The applicant may give a presentation of a maximum of 15 minutes in order to allow sufficient time for discussion on the requested topic.

It is the responsibility of the applicant to draw up the minutes of the consultancy / Scientific Advice meeting* and forward them to the consultant within 5 working days after the meeting. If necessary, SÚKL will modify the minutes and return the final version to the applicant within 15 working days, unless otherwise agreed.

In the event that the draft minutes of the meeting are not received by SÚKL within the deadline, the meeting will be closed as a consultation / Scientific Advice without issuing an opinion.

*Note: the preparation of the minutes by the applicant is voluntary

Payment

On the basis of the applicant´s questions, the consultant / contact person shall specify the amount to be paid for consultancy / Scientific Advice along with the reimbursement code listed in the Annex to Decree No 379/2022 Coll. and advise the applicant thereof. Various types of consultancy / Scientific Advice and the corresponding amount of reimbursement of the costs of expert activities have been determined with regard to the subject matter consulted.

Before the actual payment, the applicant needs to fill in an interactive form that generates a specific variable symbol under which the payment should be sent. In this form, all mandatory fields must be entered and thereafter, the form submitted. The advance payment for reimbursement of consultancy / Scientific Advice fees is governed by the provisions of Article 67(1) of Act No 375/2022 Coll.

Acknowledgement of payment of the aforementioned fees will be sent to the applicant after payment has been made or may alternatively be delivered in person at the meeting.

SÚKL will not provide consultancy / Scientific Advice unless the advance payment for the costs of the expert activity is paid.