Medical device CE marking

European Commission issues Q&A on Article 10a of the MDR/IVDR

2024-10

It is a Q&A on practical aspects related to the implementation of the Article 10a obligation in case of interruption or discontinuation of supply of certain devices as introduced by Regulation (EU) 2024/1860 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards a gradual roll-out of Eudamed, the obligation to inform in case of interruption or discontinuation of supply, and transitional provisions for certain in vitro diagnostic medical devices.

There are answers to the following 14 questions:

  1. From when does the new Article 10a of the MDR/IVDR apply?
  2. To whom does the obligation to inform of an anticipated interruption or discontinuation of supply of certain devices under Article 10a(1) of the MDR/IVDR apply?
  3. To which “certain devices” does Article 10a(1) of the MDR/IVDR apply?
  4. Who should the manufacturer inform under Article 10a (1) of the MDR/IVDR?
  5. When should a manufacturer inform under Article 10a (1) of the MDR/IVDR?
  6. What is meant by “exceptional circumstances” in Article 10a (1) second subparagraph of the MDR/IVDR?
  7. What is meant by the “anticipation of an ‘interruption or discontinuation’ of the supply of a device” as outlined in Article 10a (1) of the MDR or IVDR?
  8. What are the categories of reasons for the interruption or discontinuation which the manufacturer would be expected to specify in its notification to the competent authority under Article 10a (1) of the MDR/IVDR?
  9. What is considered as an ‘interruption or discontinuation that may result in serious harm or a risk of serious harm to patients or public health’ in one or more Member States under Article 10a (1) of the MDR/IVDR?
  10. Is the information provided to the competent authority subject to Article 109 MDR/102 IVDR?
  11. How should the information to the competent authority under Article 10a be provided?
  12. Which information should be included in the ‘Manufacturer Information Form’2 for notification to the competent authority under Article 10a?
  13. What is the responsibility of other economic operators in the supply chain under Article 10a(3) of the MDR and IVDR after receiving the information from the manufacturer?
  14. Does Article 10a of the MDR/IVDR apply to system or procedure packs?

The Q&A can be downloaded in our library.

Source: European Commission

MDCG 2022-5 Rev. 1 published on (MDR) borderline products: medical devices and medicinal products

2024-10

On October 29, 2024 the MDCG published Revision 1 of MDCG 2022-5: Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices.

The document starts with the general discussion of the borderline between medical devices and medicinal products, including relevant definitions and examples. Separate chapters are dedicated to herbal products, substance-based devices and medical device and medicinal product combinations.

The document can be downloaded in our library

Source: European Commission

MDCG 2021-25 Rev.1 report issued on transitional provisions

2024-10

The MDCG ad hoc task-force on transitional provisions (‘legacy devices’ and devices placed on the market prior to 26 May 2021 in accordance with Directives 90/385/EEC or 93/42/EEC) has issued Revision 1 of the MDCG 2021-25 report, which has been endorsed as an MDCG guidance.

The document can be downloaded in our library

Source: European Commission

 

Current status MDR / IVDR Notified Bodies

2024-10

At the moment there are 50 notified bodies designated to perform audits according the MDR:

The current status of NBs under the IVDR is 13:

Source: NANDO database

Call to medical device manufacturers: implement an effective PMS system

2024-10

Original communication:

Manufacturers should pay more attention to the continuous monitoring of the safety of medical devices

It is important that medical device manufacturers continuously monitor the quality and safety of their products. European regulations apply to the implementation of this surveillance, also called Post-Market Surveillance (PMS). The Dutch inspection (IGJ) visits to 13 manufacturers showed that manufacturers do not comply with this or do not comply sufficiently. Most manufacturers seem to give too little priority to PMS. The inspectorate calls on manufacturers to change this. It is about patient safety, but also about the improvement and further development of medical devices.

Post-Market Surveillance contributes to the safe use of medical devices
Medical devices include diagnostic tests, medical software, IV poles or treatment tables. PMS consists of activities that a manufacturer must perform to monitor the performance and safety of the device. Examples include conducting (user) research into the product and analyzing incidents and complaints.

It is important that manufacturers continually assess whether the benefits of their product outweigh the risks. If necessary, they must make adjustments or improvement measures. Regular reporting of PMS results is also mandatory. This applies from the moment a product is placed on the market. The purpose of PMS is that the manufacturer always has the correct information about the medical device and thus improves its safe use.

None of the 13 manufacturers met the PMS requirements
In 2023 and 2024, the Dutch inspectorate visited 13 manufacturers of various medical devices, software applications and in-vitro diagnostics (tools for testing human body material, such as a pregnancy test). None of the 13 fully met the European requirements for PMS. The IGJ often saw, among other things, that a PMS plan is missing, knowledge is limited or that the PMS is not focused on the medical device in question. The manufacturers themselves often indicate that they find the regulations complex. The IGJ has asked the manufacturers to resolve the shortcomings.

IGJ call to manufacturers: work on PMS
Following these inspections, the IGJ encourages all manufacturers of medical devices to implement PMS and to give it priority. This can be done, among other things, by clearly assigning responsibility for PMS within the organization and making it part of the entire quality system.

In the coming period, the IGJ will continue to visit manufacturers of medical devices to check whether they meet the PMS requirements. In addition, the IGJ continues to draw attention to the importance of quality and safety control at both national and international levels.

The publication can be downloaded in our library

Source: Call to medical device manufacturers: implement an effective PMS system | Publication | Health and Youth Care Inspectorate (igj.nl)

 

Revision 2 of MDR and IVDR language requirements for manufacturers published

2024-09

The Commission and Member States have created a revision 2 of the MDR and IVDR tables.

These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and medium-sized ones, understand the language requirements for the information and instructions that accompany a device in a specific country. The tables provide an overview of the language requirements for each Member State.

Graphic User Interface (GUI)
The last column of the tables includes the language requirements about the graphic user interface (GUI) (e.g., apps). There is no specific article foreseen in MDR/IVDR, but some countries have their own national legislation and rules about GUIs.

The documents can be downloaded in our library: MDR / IVDR

Source: European Commission

All documents related to the MDR and IVDR amending Regulations

2024-07

Please find below an overview of all documents related to the MDR and IVDR amendments, Regulations (EU) 2023/607 and (EU) 2024-1860.

You can press on the link to download the document in our library.

MDR/IVDR amending Regulations:

MDD/MDR related documents:

IVDD/IVDR related documents:

 

Manufacturer’s Declaration in relation to Regulation (EU) 2024/1860

2024-07

MedTech Europe published a template Manufacturer’s Declaration to facilitate the declaration of manufacturers with respect to Regulation (EU) 2024/1860 and:

  • The extended transitional periods for devices for which the conformity assessment procedure pursuant to Directive 98/79/EC (IVDD) did not require the involvement of a notified body and/or
  • The validity of certificates issued under Directive 98/79/EC (IVDD) (Directive Certificate) and/or
  • The compliance of the Legacy Devices and their manufacturer with the conditions for the continued placing on the market and putting into service.

Any In Vitro Diagnostics manufacturer may freely use this template to make their own declaration of the above. It may also be completed by the authorised representative on behalf of the manufacturer. The way in which the manufacturer declares their compliance with the applicable conditions is disclosed by the manufacturer in the completed form.

The template consists of two parts:

  • A text part with selectable portions of text as they apply and
  • A schedule which lists the devices which the manufacturer intends to cover in its Declaration.

The document can be downloaded in our library

Source: MedTech Europe

Please note that a template Manufacturer’s Declaration in relation to Regulation (EU) 2023/607 can be downloaded in our library here.