1. Introduction
2. Definitions
3. Application
4. Clinical investigation plan
5. Supply/sale
6. Labelling
7. Subject Information
8. Authorisation
9. Amendments to the clinical investigation
10. Completion of investigation
11. Management of adverse events
12. Final Report
13. Danish Medicines Agency handling of application
14. Inspections
15. Conduct and reporting of clinical investigations
16. Legislation
17. Contact
A clinical investigation is any designed and planned systematic study in human subjects undertaken to verify the safety and/or performance of a specific device.
The following clinical investigations of medical devices in Denmark require authorisation by the Danish Medicines Agency:
- non CE-marked devices
- CE-marked devices, if the objective of the investigation is application of the device for an intended purpose for which the device is not CE-marked.
- in vitro diagnostic devices, if the device is intended to come in direct or indirect contact with the human body.
The clinical investigation may be initiated when authorisation from the Danish Medicines Agency as well as permission by the relevant scientific ethical committee has been granted. The intention is to ensure that only investigations where risks and benefits in relation to patient safety are acceptable are initiated.
Note: Clinical investigation of CE-marked devices utilised for their intended purpose do not require authorisation by the Danish Medicines Agency, however, this type of investigation may require notification to the scientific ethical committee.
Requirements for clinical investigations are described in the relevant harmonised standards published by the national standards organisation:
- EN ISO 14155-1 “Clinical investigation of medical devices for human subjects – Part 1: General requirements”
- EN ISO 14155-2 “Clinical investigation of medical devices for human subjects – Part 2: Clinical investigation plans”
The harmonised standards specify the method of how to document that the investigation is conducted in accordance with the legal requirements. If standards are not applied, it shall be otherwise demonstrated how the legal requirements are met.
| Accessory: |
An article which whilst not being a device is intended specifically by its manufacturer to be used together with a device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device.
Note: accessories shall be treated as medical devices in their own right.
|
| Adverse Event: |
Any untoward medical occurrence in a subject. This definition does not imply that there is a relationship between the adverse event and the device under investigation.
|
| Case report form: |
Document designed to record all information to be reported to the sponsor on each subject as required by the clinical investigation plan.
|
|
Clinical Investigation: |
Any designed and planned systematic study in human subjects undertaken to verify the safety and/or performance of a specific device.
|
| Clinical Investigation Plan: |
A document that states the rationale, objectives, design and proposed analysis, methodology, monitoring, conduct and record-keeping of the clinical investigation.
Note: The word “protocol” is often used synonymously with the term “clinical investigation plan”. However, it has many different meanings, some not related to clinical investigations, and these may differ from country to country.
|
| Coordinating investigator: |
The clinical investigator that is appointed to coordinate work in a multi-centre clinical investigation.
|
| Investigator: |
Individual and/or institution responsible for the conduct of a clinical investigation who and/or which takes the clinical responsibility for the well-being of the subjects involved.
|
| Investigator’s Brochure: |
Compilation of the clinical and non-clinical information on the device(s)nder investigation, that is relevant to the investigation in human subjects.
|
| In vitro diagnostic medical device: |
Any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
- concerning a physiological or pathological state, or
- concerning a congenital abnormality, or
- to determine the safety and compatibility with potential recipients, or
- to monitor therapeutic measures.
Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
|
| Letter of authority: |
A statement in which the subject gives third parties (e.g. the Danish Medicines Agency) access to their patient records for a specified time limit, for monitoring, auditing and inspection of a clinical investigation.
|
| Medical device: |
Any instrument, apparatus, appliance, material or other article, whether used alone or in combination, including the software necessary for its proper application, intended by the manufacturer to be used on human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomy or of a physiological process,
- control of conception,
and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
|
| Monitor: |
Individual appointed by the sponsor responsible for assessing the investigator's compliance with the clinical investigation plan and for performing source-data verification.
|
| Multi-centre investigation: |
Clinical investigation which is conducted according to a single clinical investigation plan and which takes place at two or more centres.
|
| Principal investigator: |
The clinical investigator responsible for the organization of the clinical investigation at one site.
|
| Reference number: |
Sponsor’s unique ID number for the clinical investigation plan.
|
|
Serious Adverse Event (SAE/SADE): |
Adverse event that led to a death, led to a serious deterioration in the health of the subject that resulted in a life-threatening illness or injury, resulted in a permanent impairment of a body structure or a body function, required in-patient hospitalization or prolongation of existing hospitalization, resulted in medical or surgical intervention to prevent permanent impairment to body structure or a body function or led to foetal distress, foetal death or a congenital abnormality or birth defect.
|
| Sponsor: |
Individual, institution or organization who or which takes responsibility for the initiation and/or implementation of a clinical investigation.
|
|
|
Handling of the application will be initiated when the application is considered complete, see section 3.6.
3.1 Application Form
The Danish Medicines Agency's application form for clinical investigation shall be enclosed in the submission. The application form discloses which associated information needs to be provided. The submission shall contain a covering letter, including a list of all appendices and a description of all special conditions relevant for the application.
The application should be addressed to:
Danish Medicines Agency
Medical Devices, Consumer Safety Division
Axel Heides Gade 1
DK-2300 Copenhagen S
Denmark
One copy of all documents with relevant signatures shall be submitted. Furthermore, we would also appreciate receiving an electronic copy of the documents (CD-ROM).
3.2 Fees
The Danish Medicines Agency is authorised to collect a fee to cover the agency’s expenses in connection with the handling of applications for authorisation of clinical investigations of medical devices according to the Ministry of Health and Prevention's Executive Order for fees on medical devices.
The fees apply to all investigations covered by the requirement for authorisation and the Danish Medicines Agency has no statutory authority to grant exemption from these.
The fee shall be paid to the Danish Medicines Agency after receipt of the invoice.
When submitting amendments to investigation plans not yet authorised, no further fees are to be paid to the Danish Medicines Agency. If this material is submitted while the application is being handled, this may, depending on the nature of the amendment, take longer for the Danish Medicines Agency to reply to the application.
3.3 Language
The Danish Medicines Agency accepts applications in Danish as well as in English.
3.4 Sponsor
The application shall be submitted by the sponsor i.e., the individual, institution or organization who or which takes responsibility for the initiation and/or implementation of a clinical investigation. The sponsor may delegate investigation related duties to a designated representative; in this case documentation of this relation shall be provided.
The sponsor or the sponsor’s legal representative shall have a permanent address in an EU/EEA country.
3.5 Application for a multi-centre investigation
For investigations being conducted at more than one centre in Denmark, only one full application should be submitted by the sponsor. Each of the participating investigation centres shall be listed on the application form.
3.6 Content of the application
The application shall contain the following documents:
- Covering letter with a list of appendices and possible special considerations, which the agency shall be aware of.
- Clinical Investigation Plan
- Investigator’s Brochure
- The patient/subject information sheet
- Authorisation sheet, allowing the Danish Medicines Agency and the monitor to access the subject’s journal.
- Statement certifying that the device in question complies with the Essential Requirements apart from those aspects covered by the investigation, and that with regard to these aspects, every precaution has been taken to protect the health and safety of the subject.
- A description of the specified intended use of the CE-marked device, a copy of the device’s Declaration of Conformity as well as certificates from the Notified Body, if relevant.
- Copy of the Scientific Ethical Committee's opinion, if available.
- Picture of the device or a specimen, if appropriate.
The Danish Medicines Agency Executive Order on the applications for the authorisation for clinical investigations of medical devices on human subjects provides a list of information and documentation that the application shall contain. Should a limited number of items in the Executive Order be considered irrelevant for a specific clinical investigation, the covering letter shall contain a list of these items as well as the justification for the omissions.
3.7 Contraception
Where relevant it shall be clearly stated in the clinical investigation plan or in an amendment to this, that it is ensured that fertile women are not pregnant when included in the investigation (negative pregnancy test at the inclusion) and that safe contraception is used. The Danish Medicines Agency considers the following contraceptive methods to be safe in connection with clinical investigations:
- intrauterine devices
- hormonal contraceptives:
- contraceptive pills
- implants
- transdermal patches
- hormonal vaginal devices
- injections with prolonged release.
It is accepted in certain cases to include subjects having a sterilised regular partner or subjects using a double barrier contraceptive method. However, this should be explicitly justified in special circumstances arising from the study design, product characteristics and/or study population. For the purpose of this guideline, double barrier method of contraception means a condom combined with a diaphragm.
Sterilised or infertile subjects are exempt from the requirement to use contraception. In order to be considered sterilised or infertile, subjects shall generally have undergone surgical sterilisation (vasectomy/bilateral tubectomy, hysterectomy or bilateral ovariectomy) or be postmenopausal defined as 12 months or more with no menses prior to enrolment.
For some individuals or special populations, there may be arguments against using the above-mentioned methods of contraception. Examples include seriously ill, hospitalised patients or fertile children who are not sexually active.
The Clinical investigation Plan (CIP) is considered to be a working document for Sponsor, Investigators and Monitors, and it shall contain all information that are relevant for the conduct of the clinical investigation. The CIP is a living document that at all times describes the current practice for the investigation, including:
- General administrative information
- Information about the medical device under investigation
- The objective of the investigation
- The design of the investigation
- Inclusion/exclusion criteria
- Statistical justification and methods for data analysis of the results
- Handling of all adverse events
- Unscheduled termination of the investigation
- Ethical considerations
- Quality control and quality assurance
- Publication policy
It is important that the CIP contains the information listed in The Danish Medicines Agency Executive Order on the applications for the authorisation for clinical investigations of medical devices on human subjects. In case the Sponsor assesses that certain items in the executive order to be non-applicable for a specific investigation, a justification for this shall be provided.
Non-compliance to the Clinical Investigation Plan
A procedure for preauthorisations of non-compliance from the clinical investigation plan (waivers) is in general not accepted by the Danish Medicines Agency.
During the conduct of the clinical investigation, the Case Report Form (CRF) provides the practical means to comply with clinical investigation plan. The CRF shall at all times reflect the CIP and information that is not reflected in the CIP shall not be included in the CRF.
Devices under investigation may only be made available when the authorisation for clinical investigation from the Danish Medicines Agency has been granted.
The labelling and instructions for use of devices under clinical investigation shall include all relevant information as described in the appendix 1 (the essential requirements) of the applicable executive order for medical devices.
NOTE: “udelukkende til klinisk afprøvning” (the Danish text for “exclusively for clinical investigations) shall be stated on the labellingand relevant instructions for use of the device under investigation.
7.1 Subject information and informed consent
Regulation on how to inform and obtain consent from subjects participating in clinical investigations are to be found in the Executive Order on information and consent on involving trial subjects in biomedical research projects. Among other things, this stipulates what information the written and verbal information shall contain and how to obtain consent from subjects. Furthermore, guidelines for this can be found in the “Guidance on information and consent when involving trial subjects in biomedical research projects and on application for and assessment of research projects by the Scientific Ethical Committee”. For further information, please contact the Central Scientific Ethical Committee at cvk@sum.dk.
Monitoring, auditing and inspection of clinical investigations of medical devices require access to patient records. Information on individual persons’ state of health is covered by the rules on confidentiality in the Danish Health Act and the penal code. Consequently, a hospital may not give third parties access to patient records. Third parties include monitors, auditors and inspectors.
Individual patients can give their consent to company representatives and/or authority representatives to access their records. However, pursuant to the Danish Health Act, this consent expires no later than one year after it is given.
7.2 Letter of authority
Instead of consent, a letter of authority may be used. Under the Danish Health Act, patients have access to their own records. In pursuance of the Danish Public Administration Act, patients may allow another person, including e.g. the monitor, to access their record on their behalf. Such an acceptance of access to the records by another person shall be by means of a letter of authority. A letter of authority – unlike consent – is not subject to a one-year time limit.
The letter of authority should clearly appear exactly as a letter of authority, and it should be precisely formulated so as to avoid any doubt with regard to what it covers. The letter of authority should therefore be an independent document, from which it appears:
- the document is a letter of authority (title)
- who is granting the letter of authority (the subject)
- to whom it is granted (monitor, sponsor, authorities)
- what the letter of authority is intended for (access to the patient records under the Patients' Rights Act)
- for what purpose (monitoring, audit, inspection)
- what information and within what period
- for which period of time the letter of authority is valid.
A condition for granting authorisation for the conduct of a clinical investigation is that a letter of authority is obtained, granting the Danish Medicines Agency access to the information.
The written subject information and the form for obtaining letter of authority shall be enclosed with the application to ensure that the above mentioned control can be conducted. The actual assessment of the subject information is carried out by the Scientific Ethical Committee Systsem.
The investigation may be initiated when the Danish Medicines Agency has granted an authorisation and the Scientific Ethical Committee has approved the investigation.
9.1 Significant amendments
The sponsor shall apply for authorisation to implement subsequent significant amendments to the clinical investigation plan. Amendments are considered to be significant if they may have impact on:
- Patient safety
- Interpretation of the scientific documentation that serves as the foundation of the investigation
- Conduct or management of the investigation, including the introduction of a new coordinating investigator, inclusion of a new Danish centre or new Danish principal investigators
- Quality or safety of the medical device under investigation
- Other significant aspects.
Application form for the authorisation to make amendments to the clinical investigation shall be signed by the Sponsor. Amendments may only be implemented once the Danish Medicines Agency has granted authorisation.
The associated fee shall be paid to the Danish Medicines Agency after receipt of the invoice.
Major amendments may cause the submitted material to be regarded as a new investigation plan i.e., an application for a new investigation. If this is considered to be the case the Danish Medicines Agency will inform sponsor accordingly.
If the sponsor or investigator becomes aware of circumstances, which might entail a risk to subjects' safety, the sponsor or investigator shall immediately undertake the arrangements necessary to protect the subjects. The sponsor shall immediately notify the Danish Medicines Agency of these new circumstances, the arrangements made and state these arrangements as an amendment to the investigation.
9.2 Administrative changes
For inclusion of additional centres situated outside of Denmark there are no further fees. This equally applies for inclusion of additional Danish investigators besides the principal investigator.
The criteria for the completion of the investigation shall be provided in the investigation plan. Usually this is the last visit of the last patient.
10.1 Completion of the investigation according to plan
The Sponsor shall inform the Danish Medicines Agency that the investigation has been completed, no later than 90 days after completion of the investigation.
Information about completion of the investigation should be submitted using the form Notification of completion/termination of the Clinical Investigation.
10.2 Premature termination of the investigation
If an investigation is terminated prematurely the Danish Medicines Agency as well as the Scientific Ethical Committee shall be informed within 15 days upon termination.
Information about completion of the investigation should be submitted using the form Notification of completion/termination of the Clinical Investigation.
10.3 The Danish Medicines Agency terminates or prohibits an investigation
If the Danish Medicines Agency during the investigation has objective grounds for assuming that the investigation is not being conducted according to the application or authorisation or if any other circumstances give rise to doubt about the safety and the scientific aspects of the investigation, the Danish Medicines Agency is entitled to demand that the investigation be amended, temporarily suspended or prohibited.
Before the Danish Medicines Agency makes a final decision on the above, the Agency will request a statement from the sponsor and/or investigator, which shall be provided to the Agency within 7 days.
The Danish Medicines Agency may refrain from obtaining this statement if it is assessed that postponing the decision may entail a safety risk to the subjects.
If deciding to suspend or prohibit an investigation, the Danish Medicines Agency immediately announces this decision and its grounds to the affected Scientific Ethical Committee, the European Commission and the other EEA countries.
11.1 Serious adverse events
Sponsor shall inform the Danish Medicines Agency of all serious adverse events and near- incidents that occur in Denmark during the investigation. Serious adverse events and near-incidents are the equivalent of serious adverse events (SAEs) and serious adverse device effects (SADEs) as defined in EN ISO 14155-1.
A serious adverse event is an adverse event that led to or may have led to:
- death
- a life-threatening illness or injury
- a permanent impairment of a body structure or a body function
- in-patient hospitalization or prolongation of existing hospitalization
- medical or surgical intervention to prevent permanent impairment to body structure or a body function
- foetal distress, foetal death or a congenital abnormality or birth defect.
A near-incident is an adverse event that might have led to any of these consequences if suitable action had not been taken or intervention had not been made or if circumstances had been less opportune.
Note: the obligation of incident reporting also covers adverse events and near incidents that are due to imprecise or incomplete results from diagnostic equipment, e.g.:
- incorrect diagnosis
- delayed diagnosis
- delayed treatment
- incorrect treatment.
Sponsor shall ensure that a careful evaluation of adverse events and near-incidents is performed, with a view to determining, whether or not the event is related to the medical device or the investigation, or may have a causal relation to these.
Sponsor shall ensure that information on serious adverse events and near-incidents are recorded and notified to the Danish Medicines Agency as soon as possible, and no later that 7 days after sponsor has been made aware of the event.
Information about serious adverse events or near-incidents should be submitted using the form Notification of a serious adverse event or near-incident with medical device during a clinical investigation.
8 days at the latest after the notification of the event, at the latest, sponsor shall inform the Danish Medicines Agency of pertinent information regarding sponsor’s and principal investigator’s follow-up. Each notification shall include a comment about consequences for the investigation.
According to national guidelines, serious adverse events shall be reported to the competent authority in all member states in which the investigation is being conducted.
All adverse events occurring during the investigation shall be reported in the final report. This includes adverse events occurring outside Denmark as well as adverse events that have been categorised as non-serious.
11.2 Annual report and list of adverse events
Once a year throughout the duration of the clinical investigation, the Sponsor shall submit a report on the safety of the subjects to the Danish Medicines Agency. As a minimum, the annual report shall contain the following information:
- A list of all serious adverse events and near-incidents (in Denmark as well as the rest of the world) occurring during the investigation.
- An evaluation of each serious adverse event and near-incident.
- An assessment of the risk/benefit of the device under investigation.
- A conclusion on the safety of the subjects, taking the adverse events into consideration.
The Sponsor shall inform the Danish Medicines Agency that the investigation has been completed, no later than 90 days after completion of the investigation. As soon as possible thereafter, and no later than a year after the completion of the investigation, the sponsor shall submit the final report to the Danish Medicines Agency. The final report shall contain a critical evaluation of all the data collected during the clinical investigation.
The Danish Medicines Agency will send a letter confirming receipt of the application. The letter will provide the date of receipt as well as the Danish Medicines Agency’s journal number, which should be referenced in any future correspondence concerning the application. Furthermore, the letter will state that within 14 days, the applicant will be informed of whether or not the application is considered to be properly completed. For an application to be properly completed, it shall contain all the information and documentation stated in the Executive Order on application for the authorisation for clinical investigations of medical devices on human subjects.
- If the application is considered to be properly completed, the Danish Medicines Agency will initiate its review process. The starting date of the review process will be the date of receipt of the application by the Danish Medicines Agency.
- If the application is considered not properly completed, the Danish Medicines Agency will send a letter requesting the missing information. The review process will be initiated upon receipt of the missing information. The starting date of the review process will be the date of receipt of the missing information by the Danish Medicines Agency. If the requested information is not submitted, the application will be returned.
For an application to be considered properly completed the referenced documents in section 3.6 shall contain sufficient information, including the final results of preclinical testing.
When the application is considered properly completed, the Danish Medicines Agency will forward a letter, including the starting date of the review process. The letter will also state that the review process may take up to 60 calendar days. If any shortcomings are found during the review of the application, the Danish Medicines Agency will request the missing information with a deadline for submission.
It is important that the deadline for submission of additional material is met, as the 60 calendar days review process cannot be suspended. In case the requested additional information is not received by the Danish Medicines Agency within the specified time frame, a decision will be made based on the information and documentation available at the time.
The result of the review process may be:
- Authorisation
- Authorisation with conditions
- Authorisation with conditions that require approval
- Non-acceptance
If the result of the review process indicates a possible non-acceptance of the application, a Letter of objection will be forwarded, including a deadline for submission of the response to the letter. The Sponsor has one opportunity to respond to the Letter of objection, e.g. by submission of additional information. Failure to respond adequately to the Letter of objection will result in a non-acceptance of the application.
The Danish Medicines Agency will communicate all non-acceptances, including the grounds for objection to the European Commission and all other EEA countries.
13.1 Other authorities
13.1.1 Scientific Ethical Committee
According to the Act on a Scientific Ethical Committee System and the Processing of Biomedical Research Projects, one of the regional scientific ethical committees shall approve biomedical research projects. This also applies to clinical investigations of medical devices.
The Danish Medicines Agency notifies the scientific ethical committee concerned of its final decision concerning the application.
Further information on applications to the scientific ethical committee can be obtained from the website of the Danish National Committee for Biomedical Research Ethics’s www.cvk.sum.dk, where links to the ethical committee system's electronic application form and to the regional scientific ethical committees are provided.
The Danish Medicines Agency’s evaluation of an application may take place at the same time as the evaluation by the scientific ethical committee system. For the sake of the review process, it is important that the content of the clinical investigation plan, which forms the basis for the evaluation in the two systems, are identical.
13.1.2 Data Protection Agency
According to the Danish Act on the Processing of Personal Data, clinical investigations of medical devices shall also be notified to the Danish Data Protection Agency. This may take place at the same time as the application to the Danish Medicines Agency.
For further information on notification requirements, please see the Danish Data Protection Agency’s website www.datatilsynet.dk.
13.1.3 Danish National Institute of Radiation Protection
Medical devices emitting ionising radiation require approval by the Danish National Institute of Radiation Protection prior to use in a clinical investigation. Further information on notification and approval may be obtained by contacting the institute (contact details on www.sst.dk).
Every year, the Danish Medicines Agency carries out inspections on a random sample basis of clinical investigations for which authorisation has been granted. Inspections may take place at the premises of all parties involved in a clinical investigation, e.g. Sponsor, Investigator, CRO and laboratories.
The purpose of the inspections is to check if the clinical investigation is carried out in compliance with the Danish legislation, the authorised CIP and other regulations that the Sponsor has specified as being applicable for the investigation. As a minimum, all clinical investigations shall be carried out in accordance with the international standard for clinical investigation on human subjects. This includes, e.g.:
- All involved parties have appropriate qualifications to manage their tasks as identified in the CIP.
- Sponsor maintains a quality system to document that all involved parties at all times comply with the CIP and other relevant requirements for the investigation.
- Compliance with the approved CIP.
- All applicable approvals have been obtained and maintained.
The Medical Device Section of the Danish Medicines Agency is responsible for reviewing applications for clinical investigations and for issuing authorisations. To ensure that the inspections are impartial, they will not be conducted by an employee of the Medical Device Section, but by a GCP-inspector, who has experience with conducting inspections of clinical trials of medicinal substances and who has been trained in the legislation and relevant applicable standards for medical devices. An inspection of a clinical investigation will only be carried out to ensure compliance with the requirements that are applicable for the specific investigation as defined by the Sponsor, e.g. ISO 14155. An employee of the Medical Device Section may participate in the inspection as a technical resource.
An Inspection Report will be written at the end of each inspection and provided to the Sponsor and the inspected party. The report will contain a summary of the inspection, including possible non-compliances with applicable regulations found during the inspection and may require follow-up activities.
The Danish Medicines Agency may check all resources related to any clinical investigation of medical devices and the Agency can require all information necessary to check these activities. The Danish Medicines Agency representatives have the right to access the patient records and related documentation if the subject, his/her closest relatives or his/her legal guardian has given consent or legal authorisation. Furthermore, the clinical investigation plan shall include information that the investigator allows the representatives of the Danish Medicines Agency to access the patient records and related documentation during an inspection.
When the Danish Medicines Agency has decided to conduct an inspection, the Sponsor and other involved parties of the inspection will be contacted to further plan the administrative details of the inspection.
Practical guidance on the conduct and reporting of clinical investigations is available in the relevant standards:
- EN ISO 14155-1 “Clinical investigation of medical devices for human subjects – Part 1: General requirements”, and
- EN ISO 14155-2 “Clinical investigation of medical devices for human subjects – Part 2: Clinical investigation plans”, published by the national standards organisation.
Regulations for medical devices are implemented by Acts and Executive Orders in Denmark. These are only available in Danish. An overview is listed below.
Act:
- Lov nr. 1046 af 17. december 2002 om medicinsk udstyr.
Executive Orders:
If you should have queries, please contact the Medical Devices Section on:
- Telephone:+45 4488 9595
Monday-Thursday 8.30 -16.00 and
Friday 8.30-15.30
- E-mail: Med-udstyr@dkma.dk
- Danish Medicines Agency
Medical Devices, Consumer Safety Division
Axel Heides Gade 1
DK-2300 Copenhagen S
Denmark
Danish Medicines Agency, March 2010
Changelog
Definitions
Three new definitions:
· Investigator’s Brochure
· Letter of authority
· Reference number
Content of application
New list of documents the application shall include at submission.
Contraception
New paragraph concerning the requirement for the subjects' use of contraception during the investigation..
Clinical Investigation Plan
New paragraph concerning non-compliance to the Clinical Investigation Plan.
Amendments
New paragraph concerning payment of associated fee to the Danish Medicines Agency after receipt of the invoice
Serious adverse events
New paragraph concerning reporting of s erious adverse events to the competent authority in all member states where the investigation is being conducted
The Danish Medicines Agency's handling of application
Addition of paragraph concerning properly completed the application shall contain referenced information, including the final results of preclinical testing.
Executive orders
Updated references to applicable regulations.
|
