2025-01

This document aims to clarify important terms and concepts that are outlined in Section 2 of Chapter VII of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

Establishing a common understanding of these terms and concepts is necessary for the effective and harmonised implementation of the vigilance requirements under these Regulations.

The document is written for competent authorities, economic operators and other relevant parties. Some of the definitions presented in this document are reintroduced from the Guidelines on a Medical Devices Vigilance System with, where relevant, modifications for alignment with the MDR and IVDR.

Unless quoted directly from the legal text or otherwise specified, the term ‘devices’ will be understood to include medical devices, accessories for medical devices, products listed in Annex XVI of the MDR, in vitro diagnostic medical devices and accessories for in vitro medical devices. Furthermore, references to ‘the Regulations’ should be understood to cover both the MDR and the IVDR.

The document can be downloaded in our library

Source: European Commission

2024-12

Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establishes the requirements for notified bodies involved in the conformity assessment of applicable classes of in vitro diagnostic medical devices (IVDs). Manufacturers must demonstrate that the devices conform to relevant requirements based upon objective evidence and analysis.

In accordance with these conformity assessment procedures, in addition to quality management system and technical documentation assessments, notified bodies are required to verify product batches of class D IVDs in line with Annexes IX and XI of the IVDR. Therefore, to verify the conformity of class D IVDs, manufacturers should forward to notified bodies the reports on tests carried out on each manufactured batch of class D devices. Furthermore, the manufacturer should make available samples of manufactured class D devices or batches of devices to the notified body in accordance with pre-agreed conditions and detailed arrangements.

The notified body involved in the conformity assessment of class D IVDs should request one of the EU reference laboratories (EURLs), as designated by the European Commission, to carry out batch testing on those devices. The EURL should, in turn, inform the notified body about its findings. Following this verification procedure, manufacturers may place class D IVDs on the market unless the notified body communicates to the manufacturer within an agreed timeframe, but not later than 30 days after reception of the samples, any other decision. In the absence of a designated EURL for a device, the requirements relating to EURLs do not have to be applied.

The revision 1 document can be downloaded in our library

Source: European Commission

2024-12

The MDCG issued revision 1 of the Guidance on sampling of MDR Class IIa /Class IIb and IVDR Class B / Class C devices for the assessment of the technical
documentation.

The document can be downloaded in our library.

Source: European Commission

2024-11

It is a Q&A on practical aspects related to the implementation of the gradual roll-out of Eudamed pursuant to the MDR and IVDR, as amended 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.

The document can be downloaded in our library

Source: European Commission

 

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

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

2024-10

The regulatory status of ethylene oxide (EtO) for the sterilisation of single-use medical devices during the manufacturing process has been discussed in relation to the Review Programme under Regulation (EU) 528/2012 on biocidal products (BPR).

Ethylene oxide (EtO) is used to sterilise a wide range of medical products, such as medical devices, in vitro diagnostic medical devices (IVDs) and medicinal products, as well as products combining them. Sterilisation of products that are placed on the market in sterile condition is part of the manufacturing process and is usually carried out in large industrial units either by the manufacturers themselves or by external sterilisation service providers.

On a much smaller scale, EtO is also provided in cartridges for sterilisation of reusable medical devices, mainly in health institutions for use of such devices. Those EtO-containing cartridges, which are used for the supply of EtO to specific EtO sterilisers, are generally CE marked in accordance with the previous Directive 93/42/EEC or the current Regulation (EU) 2017/745 on medical devices (the ‘MDR’).

The document can be downloaded in our library

Source: European Commission

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

 

2024-10

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

• Germany: TÜV NORD CERT GmbH, TÜV-SUD, DEKRA Certification – Germany, TÜV Rheinland, DQS, MEDCERT, MDC, SLG Prüf und Zertifizierungs GmbH, Berlin Cert Prüf- und Zertifizierstelle für Medizinprodukte GmbH, SZUTEST Konformitätsbewertungsstelle GmbH
• Italy: IMQ, Instituto Superiore di Sanita’, ICIM S.P.A., ITALCERT SRL, Kiwa Cermet Italia S.P.A., Eurofins Product Testing Italy S.r.l., CERTIQUALITY S.r.l., TUV Rheinland Italia SRL, Bureau Veritas Italia S.P.A. , Ente Certificazione Macchine SRL, MTIC InterCert
• Netherlands: DEKRA Certification The Netherlands, Kiwa Dare B.V., BSI-NL, Scarlet NB
• Other: QMD Services GmbH (Austria), SGS Belgium NV (Belgium), UDEM Adriatic d.o.o. (Croatia), HTCert (Cyprus), Institut pro Testovani a Certifikaci, a.s. and CESKY METROLOGICKY INSTITUT (Czech Republic), TÜV SÜD Danmark (Denmark), Eurofins Expert Services Oy and SGS FIMKO OY (Finland), GMED and AFNOR Certification (France), CE Certiso Orvos, and NEOEMKI (Hungary),  NSAI (Ireland), DNV (Norway), TUV NORD Polska and Polskie Centrum Badan I Certyfikacji S.A. (Poland), 3EC (Slovakia),  Slovenian Institute of Quality and Metrology (Slovenia), Centro Nacional de Certificacion de Productos Sanitarios (Spain), Intertek and RISE (Sweden), UDEM, Notice Belgelendirme and Kiwa Belgelendirme Hizmetleri (Turkey)

The current status of NBs under the IVDR is 13:

• Austria: QMD Services GmbH
• Finland: Sertio Oy, Eurofins
• France: GMED SAS
• Germany: DEKRA Certification – Germany, TÜV Rheinland, TÜV-SUD, MDC Medical Device Certification GmbH
• Ireland: National Standards Authority of Ireland (NSAI)
• Italy: Instituto Superiore di Sanita’
• Netherlands: DEKRA Certification B.V., BSI-NL
• Slovakia: 3EC International a.s.

Source: NANDO database

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)