The Danish Ordinance on medical devices and products without medical purpose (BEK nr 957 af 29/04/2021) is the national implementation law applicable as of 26th of May 2021. In this sense, it states several national requirements that economic operators must follow when marketing their devices in Denmark. These are namely the following:
There is an obligation to provide labels and IFUs in the Danish language whenever the device is made available to the end-user or patient in Denmark. Nevertheless, this requirement may be ruled out by the Danish Medicines Agency in exceptional cases (Art. 3, Para. 2 of BEK), e.g., taking into consideration the user’s professional and linguistic prerequisite to use the device with an instruction in a foreign language (most often English) and the intended purpose of the device.
Similarly, translation to Danish is mandatory for the implant card and the information accompanying an implantable device. The national Medicines Agency can lift this language requirement based on specific health considerations.
Declaration of Conformity can be generated in the English language as a rule. Nevertheless, the Agency may request its translation to the Danish language for market surveillance (Art. 5 of BEK).
As per Article 87(1) of the Medical Devices Regulation 2017/745, the Danish Medicines Agency must be informed of any incident which may lead or may have led to the death of a patient or a third party or a severe deterioration of the health of a patient/third party (Art. 6 of BEK). Yet, the Danish Authority reserves the right to request from a manufacturer of “a particular type of device” to report any incident concerning its device (Art. 7 of BEK). The Danish Medicines Agency can impose the more stringent reporting obligation for a device if the Agency suspects errors, device deficiencies, or failures and therefore would need to evaluate further.
The Danish Medicines Agency also requires manufacturers to inform them of any safety-related corrective actions as per the article mentioned above.
Control measures by the Danish Authorities
Another essential element of the Ordinance is that the Danish Competent Authority may access “all relevant manufacturing, commercial and storage premises used by the manufacturer or his authorized representative” without requiring a court order to verify compliance with the Medical Devices Regulation 2017/745 and its national implementation law.
Registration of relevant actors
Regarding the registration of devices by manufacturers or authorized representatives, the following actors are requested to notify their products to the Danish Medicines Agency (Art. 10):
- Class I medical devices and custom-made manufacturers with a registered office in Denmark: must notify the name, address, and type of device;
- For non-EU manufacturers with an EAR based in Denmark: must notify the name, address, and type of the device placed on the market.
- Natural or legal persons who have their place of business in Denmark and who:
- Combine medical devices bearing CE marked devices according to their intended purpose and within limits stated by the manufacturer as a system or procedure pack
- Sterilize such system, procedure packs, or any other CE-marked medical device meant to be sterilized before use:
- Must notify their name, address, and type of device.
- For upper-class devices (Class IIa, IIb, and III) placed on the Danish market, the Danish Authority may request to receive all the information identifying the device, including its labels and IFUs. All this information shall be submitted to an electronic register.
The Danish Authority must be notified of any changes to the information previously notified. All the notifications are kept in an electronic register.
The Danish implementation law applies in its Article 11 many of the requirements mentioned in the Medical Devices Regulation 2017/745 related to clinical investigations:
- The need for the Danish CA to grant authorization for clinical trials (Art. 62(1) MDR)
- Sponsors or sponsors’ representatives must submit applications for the clinical trials (art. 70 MDR)
- Obligation to report to the Danish CA adverse events and device defects (Art. 80(2) and (3) MDR)
- Obligation of the sponsor to report to the Danish CA of the completion of the clinical trial (Art. 77(5) MDR or its interruption (Art. 77(1) MDR).
- Obligation to keep the documentation of the clinical investigation of the device concerned for 10 or 15 years for implantable devices after the clinical trial ended or after the last device was placed on the market.
Specifically for Class I, IIa and IIb non-invasive devices, the Danish Medicines Agency will decide to authorize the clinical trial in a timeframe of 45 days within the validation of the application. The Agency is empowered to request all the necessary information from those conducting the clinical trial.
Furthermore, Notified Bodies (NBs) based in Denmark are obliged to inform the Danish Medicines Agency of all certificates issued, amended, extended, suspended, and revoked, as well as any rejection of application for certificates. They shall also inform other NBs in the EEA area of suspended, and revoked certificates, refusals of applications for certificates and, if requested, of the certificates issued.
Finally, sanctions for those who do not comply with the above paragraphs are stated in Article 14 of the Ordinance, which envisages criminal liability for companies, firms or other legal persons according to the Criminal Code.
You can find the full text of the Danish Implementation law and any other law published in our MDlaw Library of Documents.
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