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Regulating medical devices in the event of a no-deal Brexit

Latest update on UK in regards to medical devices in case of no-deal Brexit published on August 8, 2019.  

UK Responsible Person:

A new role has been created, which applies from the day the UK leaves the EU.

  • must be established in the UK

  • acts on behalf of a manuf. established outside the UK

  • carries out specified tasks

  • this includes registering with the MHRA

Establish your responsible person with MDSS!

Link to the article.

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RAPS Regulatory Conference - Europe 2020

As a member of the RAPS Regulatory Conference 2020 committee, we are excited to announce the call for abstracts. Submission is now open on RAPS website, and the deadline for applications is 13 September 2019.

RAPS Regulatory Conference – Europe 2020 will provide expansive content designed by European regulatory affairs professionals. We will embrace a broad spectrum of current issues facing medical device, IVD, and medicines regulatory professionals, as well as general subjects that impact all professionals in the healthcare products space.

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Guidance on Implant Card

Medical Devices: Guidance document Implant Card relating to the application of Article 18 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices.

This document describes the intended use, content and information to be provided by the manufacturer together on the IC and a definition of fields to be completed by the implanting healthcare institutions or healthcare providers according to national law in Member States.

Example of IC Leaflet


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EC Issues Additional Guidance on Device Vigilance System

Someone may say it comes late in the game since MDR should NOW be in implemented but it is helpful for the new MIR form and for a better understanding of the collaboration among authorities.

Additional Guidance Regarding the Vigilance System as outlined in MEDDEV 2.12-1 rev. 8

The document:


  • Clarifies some of the existing definitions.

  • Introduces a new Manufacturer’s Incident Report and the new template for Field Safety Notice.

  • Introduces device specific vigilance guidance.

  • Provides further detail in relation to the area of the coordination of vigilance issues amongst Competent Authorities.

  • Clarifies the differences between the EU NCAR exchange and the IMDRF NCAR exchange.


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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


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Checklist MDR – General Safety and Performance Requirements (GSPR)

Checklist MDR GSPR  

The long-awaited checklist for the MDR compliance is available to all MDSS clients. Buy it now! 

The checklist is a great tool for the transition to the MDR with your current MDD compliant products. Are you not tired of the Notified Body answer: “What you have done for the MDD essential requirements (ER) will not be sufficient. There is definitely more for you to do with the MDR GSPR."


The checklist will provide an immediate status of the compliance evidence for the MDR GSPR with utilizing the MDD ER information. We expect that for the majority of products - in particular, the lower risk class products compliance may already be quite well established with the current information available for the MDD ER. However, as long as you cannot prove this you may lose it.

The exact differences are laid out therefore; even subtle variances will be caught. Should the current information not be sufficient, this tool will support you to identify and provide the chance to address them quickly. The sooner those gaps are identified, the better.

Once each gap is closed, you will establish full compliance.

This tool is also tremendously important to make use of the “soft transition” with your MDD certificate. This document as well provides for the MDD compliance. It fully supports the MDD certificate for the time being.  Meaning you will not be forced to maintain two set of documents. And certainly make it part of your QM System (see article 10 9. (b).

Once all gaps are addressed, then your product compliance is established and you are ready to tackle other MDR aspects with the confidence that your product is safe and performs as intended


Indeed, this should be first on the manufacturer MDR list to address! 


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Previous News

April, 2019 update

  • The Brexitxitxit ExExExtension – The never-ending Brexit story!

  • Basic GMDN membership for free

read more...


April, 2019 

  • CND code

read more... 


March, 2019 

  • Brexit: MDSS UK Subsidiary

read more...


February, 2019 - Second Update

  • Brexit: Q&A issued by the Commission on the UK leaving the EU without a deal

read more...


February, 2019 - Update

  • Vigilance Guidance update

read more...


February, 2019

  • Constant updates and where to get the right news
  • National Registration updates

read more...


January, 2019 - Second update 


  • Draft law for Brexit

  • First Notified Body

read more...


January, 2019 - Update


  • MDR

  • Brexit

read more...


January, 2019


  • Brexit

  • MDR/IVDR EU Commission website

read more...


November, 2018

  • Latest Brexit News

read more...

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