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Key Terms and Concepts in the Medical Device Regulation - Vigilance

The vigilance requirements under the EU's medical device regulations can be complex and confusing. To help you navigate this landscape, the Medical Device Coordination Group (MDCG) has released a guide to key terms and concepts in Chapter VII of the Regulation (EU) 2017/745 on medical devices (MDR).

This guide is a valuable resource for anyone involved in the medical device industry, including competent authorities and economic operators. It establishes a common understanding of important definitions and concepts necessary for effective implementation of vigilance requirements.

The guide includes definitions from the Guidelines on a Medical Devices Vigilance System, modified where necessary for alignment with the MDR. It covers medical devices, accessories for medical devices, and products listed in Annex XVI to the MDR.

While the guide is non-exhaustive, it should be read in conjunction with the MDR, relevant standards, and other MDCG guidance documents. Note that terms and concepts outlined in the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) are outside the scope of this guide.

In conclusion, our guide to key terms and concepts in the MDR is a must-read for anyone looking to understand the vigilance requirements under the EU's medical device regulations. Access this valuable resource to gain a clear understanding of these requirements and ensure effective implementation.

Download the document here: Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices .

For more news and updates from the medical device industry, be sure to check out MDSS News & Views.

Categories: News
Tags: MDR Vigilance EU MDCG

MDCG Guidance Document on IVD classification

If you're involved in the manufacture or sale of in vitro diagnostic medical devices (IVDs) in the European Union, you'll want to familiarize yourself with the MDCG guidance document on IVD classification. This document (second revision), developed by a group of experts representing Member State Competent Authorities, Commission services, notified bodies, and industry, provides guidance on how to classify an IVD prior to placing it on the market.

The guidance document covers the classification rules as set out under Annex VIII of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), as well as diagnostic or information society services performed on EU patients or devices put into service through distance sales. It also takes into account the Corrigendum published in the Official Journal of the European Union on 27 December 2019.

The primary purpose of the guidance document is to ensure the uniform application of the relevant regulatory provisions. It is intended to provide useful information for manufacturers, notified bodies, and health institutions on how to classify an IVD prior to placing it on the market. It also serves as a resource for regulators and other stakeholders when assessing the class attributed to an IVD. Examples in the document are provided for illustrative purposes only and do not represent an exhaustive list.

The guidance document should always be read in conjunction with the IVDR. By following the guidelines set out in the MDCG guidance document on IVD classification, you can ensure regulatory compliance and avoid potential issues down the line. This is particularly important given the legal empowerment for the classification of IVDs set out in the IVDR. 

The guidance document is an essential resource for anyone involved in the manufacture or sale of IVDs in the EU. In summary, the MDCG guidance document on IVD classification is an essential resource for anyone involved in the manufacture or sale of IVDs in the EU. 

By following the guidelines set out in the document, you can ensure regulatory compliance and avoid potential issues. Make sure to read the document in conjunction with the IVDR and refer to it whenever necessary.

Download the full article here: MDCG guidance document on IVD classification.

For more news and updates from the medical device industry, be sure to check out MDSS News & Views.  

Categories: News
Tags: MDCG IVDR IVD

Handling of Certification Gaps according to MDCG 2022-18

The Medical Device Coordination Group (MDCG) has released a new document that provides guidance on handling certification gaps for medical devices in the EU/EEA. The document, MDCG 2022-18, addresses the procedures for handling certification gaps for medical devices in the EU/EEA and provides guidance on market surveillance procedures for member states...

Overview: Handling of Certification Gaps according to MDCG 2022-18 in Switzerland

MDCG 2022-18 outlines the procedures for handling certification gaps for medical devices in the EU/EEA. The document provides guidance on the steps that should be taken by member states to ensure that medical devices are safe and effective. It also addresses the procedures for market surveillance and the measures that should be taken by market surveillance authorities in the event of a certification gap.

Reliance on MDCG 2022-18 Confirmations of EU/EEA Member States

MDCG 2022-18 also provides guidance on the reliance on confirmations of EU/EEA member states. The document states that member states should rely on the confirmations of other EU/EEA member states when assessing the safety and effectiveness of medical devices. This helps to ensure that medical devices are safe and effective

Market Surveillance Procedures according to MDCG 2022-18 in Switzerland

MDCG 2022-18 also provides guidance on market surveillance procedures for member states. In Switzerland, the procedure for market surveillance is outlined in the document, including the steps that should be taken by market surveillance authorities in the event of a certification gap.

Surveillance and Measures by Swiss Market Surveillance Authorities

The document also addresses the surveillance and measures that should be taken by market surveillance authorities in Switzerland. This includes procedures for monitoring the market for medical devices and taking appropriate measures in the event of a certification gap.

Free Sales Certificates

MDCG 2022-18 also provides guidance on the issuance of free sales certificates for medical devices. This includes the conditions that must be met for a device to qualify for a free sales certificate and the procedures for issuing the certificate.

Frequently Asked Questions

The document also includes a section with frequently asked questions about the handling of certification gaps for medical devices in the EU/EEA. This provides additional information and clarification on the procedures outlined in the document.

You can download the document here.

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For more news and updates from the medical device industry, be sure to check out MDSS NEWS & VIEWS. 

Categories: News
Tags: MDCG MDR IVDR Swissmedic Switzerland

Standard Fees for Notified Bodies under MDR and IVDR

The Medical Device Coordination Group (MDCG) has released a new document, MDCG 2023-2

This document, endorsed by the Medical Device Coordination Group (MDCG), outlines the standard fees for conformity assessment activities carried out by notified bodies. This document is intended to help notified bodies establish their own lists of standard fees for these activities and make them publicly available, as required by the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The MDCG explains that standard fees should be made directly and easily accessible on the website of the notified body, and should be written in the same language as the website. Additionally, the MDCG provides templates for the "List of Standard Fees" to assist notified bodies in defining their own fees for conformity assessment activities. These fees can include flat fees, hourly fees, and fees based on the specific type of activity being performed.

The MDCG clarifies the meaning of “publicly available”, which “implies that a member of the public can access this information at any point in time, without the need for additional steps.” This means that the list of fees should be easily accessible on the website of the notified body without any additional steps, for example, without the need to register as a user of the website or provide contact data. The format of the standard fee table could be any that is accessible on a common website browser.

Moreover, the currency shown should be relevant to the country where the notified body has its registered place of business. If there are regional differences in fees charged depending on the location of the manufacturer, this should also be indicated.

In conclusion, the document serves as an important guide for notified bodies to establish their own fees for conformity assessment activities in line with the MDR and IVDR regulations. The goal of this document is to provide greater transparency and fairness in the fees charged by notified bodies for their conformity assessment services.

Download the article here.

For more news and updates from the medical device industry, be sure to check out MDSS NEWS & VIEWS.

Also available in www.youregulate.com ...

Categories: News
Tags: MDR IVDR MDCG

New MDCG guidance documents!

The European Commission provides a range of guidance documents to assist stakeholders in implementing the medical devices regulations. Legally non-binding guidance documents, adopted by the medical device coordination group (MDCG) in accordance with Article 105 of Regulation 745/2017, pursue the objective of ensuring uniform application of the relevant provisions of the regulations within the EU.

Read more...

Categories: News
Tags: MDCG

Agenda of the MDCG and the MDCG subgroups has been released!

The MDCG has been created according to Article 103 and the subgroups were implemented in 2019. The task are defined in Article 105 (see below).  Most likely we will see an increase of new documents and hopefully new notified bodies after each MDCG meeting.  





Article 103 Medical Devcie Coordinating Group.
1. A Medical Device Coordination Group (‘MDCG’) is hereby established.



2. Each Member State shall appoint to the MDCG, for a three-year term which may be renewed, one member and one alternate each with expertise …



The members of the MDCG shall be chosen for their competence and experience …
The alternates shall represent and vote for the members in their absence.
3. The MDCG shall meet at regular intervals …
4. The MDCG shall use its best endeavors to reach consensus. …
5. The MDCG shall be chaired by a representative of the Commission. …
6. The MDCG may invite, on a case-by-case basis, experts and other third parties to attend meetings or provide written contributions.
7. The MDCG may establish standing or temporary sub-groups. Where appropriate, organisations representing the interests … in the capacity of observers.
8. The MDCG shall establish its rules of procedure which shall, in particular, lay down procedures for the following:
— the adoption of opinions or recommendations or other positions, including in cases of urgency;
— the delegation of tasks to reporting and co-reporting members;
— the implementation of Article 107 regarding conflict of interests;
— the functioning of sub-groups.
14. The MDCG shall have the tasks laid down in Article 105 of this Regulation and Article 99 of Regulation





Article 105 - Tasks of the MDCG
Under this Regulation, the MDCG shall have the following tasks:
(a) to contribute to the assessment of applicant conformity assessment bodies and notified bodies pursuant to the provisions set out in Chapter IV;
(b) to advise the Commission, at its request, in matters concerning the coordination group of notified bodies as established pursuant to Article 49;
(c) to contribute to the development of guidance …
(d) to contribute to the continuous monitoring of technical progress …
(e) to contribute to the development of device standards, of CS and of scientific guidelines, …
(f) to assist the competent authorities of the Member States in their coordination activities …
(g) to provide advice, either on its own initiative or at request of the Commission, …
(h) to contribute to harmonised administrative practice with regard to devices in the Member States.

Categories: News
Tags: MDCG medical devices

IMPORTANT, Important … Guidance for class I manufacturer!

MDCG 2019-15 - Guidance Notes for manufacturers of class I Medical Devices was published last Tuesday, the 17th of December.

And other guidance have been published which are also important.


You may monitor with your quality system this website of the European Union.  It seems that all guidance’s are being published here first. The docsroom.


Most certainly the overall EU website for medical devices provides further information:
Here you may subscribe to newsletter to be informed of changes.  It is our impression that it does not always work or you receive a newsletter rather late.

Categories: News
Tags: MDR class I MDCG

Guidance on software classification & other documents

The European Commission indeed works hard to provide further clarification on a number of aspects. Documents are now being issued frequently. It is great that long awaited clarification is being provided! However, stakeholder criticism is that some of the MDCG documents not only clarify aspects, but rather restate the requirements.  Another fear is, that additional requirements are being introduced with the clarification instead of providing just the needed clarifications. These two aspects may become obvious when you would apply them. We certainly would appreciate feedback regarding this matter.


In any case, those documents, if they apply to your products or system, should be considered. For example the new software guidance is very important to support your classification for your software. That document was published last Friday 2019.10.11.


Here is the list of documents for you to consider:

  • Software - First publication: 2019.10.11
  • Transitional provisions on MDD/IVD certificates - First publication: 2019.10.04
  • Call for expression of interest for expert panels - First publication: 2019.09.30
  • Manufacturer Incident Report (MIR) Form - Last update: 2019.09.30
  • Guidance on the vigilance system - First publication: 2019.09.26
  • Summary of safety and clinical performance - Last update: 2019.09.27
  • Unique Device Identification (UDI) System -  Last update: 2019.08.20


There are more documents to consider and the complete list can be found here.
It is the so called docs room which was offline for quite some time. Now, it is back.

In the past we have recommended to check here for updates but it seems that the docs room is quicker in publishing.

Categories: News
Tags: Software classification MDCG

New information on expert panels published

The MDR/IVDR envisages expert panels, who shall assist the European Commission, the Medical Devices Coordination Group, Member States, Notified Bodies and manufacturers in technical, scientific and clinical aspects.
Now a decision of the European Commission (Implementing Decision (EU) 2019/1396) has been published which describes the designation and functioning of these expert panels in more detail.
There will be 11 expert panels covering different medical areas where a need for expertise is seen. In addition, there will be another expert panel dealing with additional tasks (MDR Annex IX, section 5.1 letter c). The Medical Devices Coordination Group appoints the advisors for a term of 3 years and paid €450 per each full working day. Their independence, impartiality and objectivity should not be affected, which should be verified by a written declaration of interests. Among other things, the names of the advisors appointed, the common rules of procedure and the opinions, views and positions should be made publicly accessible in order to represent a transparent working method.
Article 54 of the MDR states in Section 1 that Notified Bodies must consult a panel of experts for special high risk products when carrying out a conformity assessment. Conversely, this means that these expert panels must already be in place for a manufacturer to complete the clinical evaluation of his high-risk product. Therefore, it is currently not possible to certify such products according to MDR and thus put them on the market. If no expert panels have been appointed by May 2020, it is expected that the concerned products will initially be certified without corresponding expertise.

Call for expression of interest for expert panels on medical devices and in vitro diagnostic medical devices (2019/C 323/05) is open!

Categories: News
Tags: MDR IVDR expert panels MDCG

MDCG Documents


MDCG Documents

A number of Medical Device Coordinating Group (MDCG) documents have been published now. The frequency of publication increased, and it is important for medical device manufacturers to take these into consideration (MDCG guidance).  

 The MDCG has been established with the Medical Device Regulation (MDR) (MDR art. 103) “1. A Medical Device Coordination Group (“MDCG”) is hereby established.” The article goes on with determining who shall participate (member state representatives) and how it is being governed (Chaired by the commission with no voting right). The MDCG has been given specific tasks (MDR art. 105), among others, to provide guidance on the harmonized implementation of the regulation.

 It is highly recommended to install in your quality system a process to monitor these guidance documents. The procedure(s) should include a regular check of the website. In case of new documents, it would involve an evaluation whether they are applicable for the company, and if so, to apply them when the specific MDR requirements are implemented. They should become part of the MDR implementation plan.

 The guidance has now been issued on various topics, and it needs to be noted that also other documents have been endorsed by the MDCG:

Other topics 
    Title     
Publication  
Date 
MDCG
2019-3
Interpretation of article 54(2)b                                                              
March 2019     

EUDAMED 
    Title    
Publication
Date 
MDCG
 2019-4
Timelines for registration of device data elements in EUDAMED          
April 2019        
MDCG
 2019-5
Registration of legacy devices in EUDAMED
April 2019

UDI 
Title
Publication 
Date
MDCG
 2019-1
MDCG guiding principles for issuing entities rules on basic UDI-DI
January 2019
MDCG
 2019-2
Guidance on application of UDI rules to device-part of products  
 referred to in article 1(8), 1(9) and 1(10) of Regulation 745/2017
February 2019
MDCG
2018-1 v2  
Guidance on basic UDI-DI and changes to UDI-DI
February 2019
MDCG
 2018-2
Future EU medical device nomenclature - Description of requirements
March 2018
MDCG
 2018-3
Guidance on UDI for systems and procedure packs
October  2018
MDCG
2018-4      
Definitions/descriptions and formats of the UDI core elements for
 systems or procedure packs
October  2018
MDCG
 2018-5
UDI assignment to medical device software
October  2018
MDCG
 2018-6
Clarifications of UDI related responsibilities in relation to article 16
October  2018
MDCG
 2018-7
Provisional considerations regarding language issues associated
 with the UDI database
October  2018

Notified Bodies 
Title
Publication 
Date 
MDCG
2019-6
Questions and answers: Requirements relating to notified bodies       
June 2019
MDCG
2018-8
Guidance on content of the certificates, voluntary
 certificate transfers
Novembe 2018
NBOG BPG
2017-1
Best practice guidance on designation and notification of conformity
 assessment bodies
February 2018
NBOG BPG
2017-2
Best practice guidance on the information required for personnel
 involved in conformity assessment
February 2018
NBOG F
2017-1
Application form to be submitted by a conformity assessment body
 when applying for designation as notified body under the
 medical devices regulation (MDR)
February 2018
NBOG F
2017-2
Application form to be submitted by a conformity assessment body
 when applying for designation as a notified body under the
 in vitro diagnostic devices regulation (IVDR)
February 2018
NBOG F
2017-3
Applied-for scope of designation and notification of a conformity
 assessment body – Regulation (EU) 2017/745 (MDR)
February 2018
NBOG F
2017-4
Applied-for scope of designation and notification of a conformity
 assessment body – Regulation (EU) 2017/746 (IVDR)
February 2018
NBOG F
2017-5
Preliminary assessment review template (MDR)
February 2018
NBOG F
2017-6
Preliminary assessment review template (IVDR)
February 2018
NBOG F
2017-7
Review of qualification for the authorisation of personnel (MDR)
February 2018
NBOG F
2017-8
Review of qualification for the authorisation of personnel (IVDR)
February 2018


Categories: News
Tags: MDCG
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