New EU legislation came into effect on May 26, 2021

After a one-year delay, MDR has come into effect on May 26, 2021.
The date of application of the IVDR remains May 26, 2022.

What does this mean for your registration obligations?

On 12 March 2020 the European Commission decided that the modules of the European registration system for medical devices and in vitro diagnostic medical devices (EUDAMED) will become available on a gradual basis. The first module, namely the registration of actors, went live on 1 December 2020. Several hundred applications for Single Registration Numbers of Dutch economic operators have since been processed.
The other EUDAMED modules were not yet ready on 26 May 2021. The European Commission expects the module for the registration of devices and certificates to go live in September 2021. As soon as the modules are ready the European Commission will make them available to the member states. In connection with this you should keep a close eye on the website of the central government and Farmatec.
Until that time it continues to be mandatory to register risk class I devices and in vitro diagnostic medical devices in NOTIS.    

What happens to your current notifications and export declarations?

All notifications and export declarations for medical devices in accordance with Directive 93/42/EEC will continue to be valid until 26 May 2021.

Medical instruments

MDD notifications

•     If your product is an MDD class I, I sterile (Is), measuring function (Im), or both (Ism), you can continue to submit notifications of your product under the MDD in NOTIS until 19 May 2021.
•     If you are withdrawing your MDD class I (low-risk) product from the market, you are obliged to unsubscribe your notification.
•     If you want to market your MDD class I (low-risk) product under the MDR as a risk class I product, you must convert your notification into an MDR notification via a change in NOTIS.
•     If you have notified us of a product in accordance with MDD class I (low risk) before 26 May 2021 and if this product falls under the MDR in a higher risk class, you can use a transition period. Your notification in NOTIS will remain valid until no later than 26 May 2024, provided you meet the condition that your product continues to comply with the MDD and does not undergo any significant changes under Article 120, paragraph 3 of the MDR.
•     If you have a medical device in a higher risk class, you do not need to submit a notification of your product in NOTIS. You can register your product in Eudamed once it becomes available.

MDD Export Declarations

As of 19 May 2021 it has no longer been possible to request export declarations for MDD products, unless:
o     your MDD product still has a valid CE certificate issued by a notified body. This applies to products in class I sterile (ls), measuring function (Im), both (Ism), or products in a higher risk class.
o     your MDD class I product falls into a higher risk class under the MDR (you should state this clearly when you submit your request). A transition period will then apply. You can request an export declaration until 26 May 2024.
•     Export declarations issued for MDD products expire when the corresponding CE certificate expires.
•     Export declarations issued for MDD class I products that fall into a higher risk class under the MDR will expire on 26 May 2024.
•     Export declarations issued for class I products without a CE certificate expired on 26 May 2021.

In vitro diagnostics

IVDD Notifications

If your product is an in vitro diagnostic medical device, you can register your IVD under the IVDD in NOTIS until 26 May 2022.
•     If your in-vitro diagnostic medical device complies with the IVDR earlier, you can submit notifications of it, or you can convert your IVDD notification into an IVDR notification via a change in NOTIS.

IVDD Export Declarations

Issued 'IVD General' export declarations are going to expire on 26 May 2022.

•           Issued 'IVD General' combined export declarations with IVDD List A, B, or self test are going to expire on 26 May 2022.

•           Issued IVDD List A, B, or self test export declarations are going to expire by no later than 26 May 2022. They may expire earlier depending on the validity date of the underlying CE certificate.

Existing or new MDD/MDR registration in NOTIS

Existing notification. If you have an existing notification for a class I medical device in accordance with MDD 93/42/EEC in NOTIS,
•     →    you can select the option in NOTIS to deregister MDD products.
•     If you are of the opinion that the existing notification meets the conditions of REGULATION (EU) 2017/745 (MDR),
→     you can amend your existing registration in NOTIS by means of a change request.
Which documents are important?
o     A Declaration of Conformity (DOC).
o     If applicable a CE certificate from a Notified Body for MDR conformity.
 
•     New notification. If you have a new class I medical device for which you want to submit a notification under the MDR,
→     please register the class I medical device in NOTIS.


Which documents are important?


o     Product Information
o     A Declaration of Conformity (DOC).
o     If applicable a CE certificate from a Notified Body for MDR conformity (class I sterile (Is), measuring function (Im), or reusable (Ir) (for the content of CE certificate please refer to Article 52.7 of the MDR).
 


Existing or new IVDD/IVDR registration in NOTIS

    Existing notification. If you have an existing notification for IVDD list A, list B, self test or other in accordance with the IVDD 98/79/EEC in NOTIS,
•     →    you do not need to take any action.
•     If you are of the opinion that the existing notification meets the conditions of REGULATION (EU) 2017/745 (IVDR),
→     you can amend your existing registration in NOTIS by means of a change request.
Which documents are important?
o     A Declaration of Conformity (DOC).
o     If applicable a CE certificate from a Notified Body for IVDR conformity.

● New IVDD notification?
Which documents are important?
o     Product Information
o     A Declaration of Conformity (DOC).
o     A valid CE certificate in the case of IVDD list A and list B and self test.
 
•     New notification. If you have a new in vitro diagnostic medical device (class A, B, C or D) for which you want to submit a notification under the IVDR,
→     it is possible to register this in NOTIS.
Which documents are important?
o     Product Information
o     A Declaration of Conformity (DOC).
o     If applicable a CE certificate from a Notified Body for IVDR conformity (class B, C and D) (for the content of CE certificate please refer to Article 48, paragraph 10 of the IVDR).
On our website you can find out which information a CE certificate or DoC has to contain.

Existing or new registration of a 'custom-made device' in NOTIS


Existing notification 

●     If you have an existing notification for a custom-made device in accordance with MDD 93/42/EEC in NOTIS,
●     and if you are of the opinion that the existing notification meets the conditions of REGULATION (EU) 2017/745 (MDR),
→     you can amend your existing registration in NOTIS in accordance with the MDR via a change request.
Which documents are important?
o     MDR declaration of conformity :You can find more information about the custom-made devices declaration of conformity in MDR EU/745 ANNEX XIII (1) PROCEDURE FOR CUSTOM-MADE DEVICES.


New notification

●     If you have a new custom-made device for which you want to submit a notification under the MDR,
→     please register the device in NOTIS.
What is important when submitting the notification?
o     Notis only offers the option of selecting Risk Class I in conjunction with the custom-made type. If you are a manufacturer of custom-made devices with a higher risk class, you have no option but to select 'Class I' in the system and to indicate which risk class the notification actually refers to in the short description field.
o     You register a custom-made device per category and not per device. You indicate the relevant category under 'Group name'.
o     During the registration process you will have to upload a declaration of conformity. This can only be in one format for custom-made devices. In other words, a representation of the declaration of conformity (excluding specifications and patient details) belonging to the product group in question.
You can find more information about the custom-made devices declaration of conformity in MDR EU/745 ANNEX XIII (1) PROCEDURE FOR CUSTOM-MADE DEVICES.
 


New registration of 'Treatment package/System or Procedure pack' in NOTIS 


New notification

●     If you have a new treatment package for which you want to submit a notification under the MDR,
→     please register the device in NOTIS.
What is important when submitting the notification?
o     In Notis you should first select the 'MDR I' risk class. At 'Type' of product you should then select 'Treatment package (System or Procedure pack)'.
o     During the registration process you will have to upload a declaration of conformity. You can find more information about the declaration of conformity in MDR EU/745 Article 22.

Where can I register the UDI number?

In NOTIS you can register the UDI number in the 'Article number(s)' field under 'Notify devices'. Incidentally, this is not an obligatory field.


How do I request an export declaration for MDD products?

•     You can request an export declaration for MDD class I products that fall into a higher risk class under the MDR in NOTIS and also for MDD class Is/Im/Ism products, or for medical devices which fall into a higher risk class, as long as the issued CE certificate is valid.
Please note:
It is not possible to issue an export declaration for class I reusable in accordance with the MDD.


Which documents are important?
•    A Declaration of Conformity (DOC) to the MDD.
•    For upclassified products: an EU declaration of conformity which has been compiled before 26 May 2021.
•    If applicable a CE certificate from a Notified Body.

How do I request an export declaration for MDR products?

You can request an export declaration for medical devices for all risk classes in accordance with the MDR in NOTIS
Which documents are important?
•     A Declaration of Conformity (DOC) to the MDR.
•     If applicable a CE certificate from a Notified Body for MDR conformity (class I sterile (Is), measuring function (Im), or reusable (Ir) (for the content of CE certificate please refer to Article 52.7 of the MDR).
•     A Word document detailing the products for which you are requesting an export declaration. If you, as a manufacturer, already have a UDI number, this number must also be stated in this Word document. As from 26 May 2021 a UDI number is obligatory for export declarations for implants and class III medical devices.
This Word document must be attached to the export declaration. The words 'See product list' must be stated on the front of the export declaration. In NOTIS you should select 'Other' at 'add document' and you should complete the 'product list with UDI numbers' subject line.
Please note:
At 'request export declaration' you can select a number of products. Within the framework of one case, you can only select products relating to the same directive/regulation.


How do I request an export declaration for IVDD products?

•     You can request an export declaration for IVDD products list A, list B, self test or other in NOTIS.
Which documents are important?
•     A Declaration of Conformity (DOC) (in the case of IVD low risk – self test, other - a copy of the DOC).
•     A CE certificate from a Notified Body in the case of high risk IVDs (list A or B).

How do I request an export declaration for IVDR products?

You can request an export declaration for an in vitro diagnostic medical device (class A, B, C or D) in accordance with the IVDR in NOTIS
Which documents are important?
•     A Declaration of Conformity (DOC) to the IVDR.
•     If applicable a CE certificate from a Notified Body for IVDR conformity (class B, C and D) (for the content of CE certificate please refer to Article 48, paragraph 10 of the IVDR).
•     A Word document detailing the products for which you are requesting an export declaration. If you, as a manufacturer, already have a UDI number, this number must also be stated in this Word document. As from 26 May 2021 a UDI number is obligatory for export declarations of class D IVDR products.
This Word document must be attached to the export declaration. The words 'See product list' must be stated on the front of the export declaration. In NOTIS you should select 'Other' at 'add document' and you should complete the 'product list with UDI numbers' subject line.
Please note:
At 'request export declaration' you can select a number of products. Within the framework of one case, you can only select products relating to the same directive/regulation.


Costs

The costs for both submitting a notification and requesting an export declaration are unchanged.

You can view the costs of notifications here.

You can view the costs of export declarations here.

Changes to notifications are, on the other hand, free of charge.