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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

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

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

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
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