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Another update on UK guidance!

Published September 3.


We will review this new update and check whether it effects our Responsible Person (RP) contract and update accordingly if needed.  


Please review for yourself.



Clarification is definitely needed because the proposed law is not clear on a very specific concern and hopefully the new guidance will provide the clarification.



STATUTORY INSTRUMENTS
2019 No. 791
EXITING THE EUROPEAN UNION
Consumer Protection


The Medical Devices (Amendment etc.) (EU Exit) regulations 2019

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It`s about time…

It is about time to start YOUR MDR/IVDR project. Even though the whole world is lamenting about the new Medical Device Regulation (MDR) and In-vitro Diagnostic Medical Device Regulation (IVDR), it will not help. The deadline will (most likely) not be moved, and being late will exclude your products from the whole EU market. Should the Member States and the Parliament indeed come to the conclusion that moving the deadline is a sensible thing to do, it may not apply for all products, and it would not hurt your business to be the frontrunner setting the stage for selling your products with being MDR compliant.




In this issue of News and Views, we will focus on the MDR, but it applies similarly to IVD products, with different timelines.


The timeline in brief:



  1. The new regulation is enforced since 2017, and in some instances can be fully applied.

  2. The new regulation must be applied in May 2020.

  3. The MDD will cease to exist.


Now we have to distinguish between two product groups.

  1. Products which are associated with a notified body (NB) and  certified with a NB. These are products of risk class IIa, IIb, III, and products of risk class I which are sterile or have a measuring function.
  2. Risk class I products.


Products which are certified with a NB:

  1. The MDR provides that those products may be ‘placed on the market’ until 2024 with a valid MDD certificate and certain MDR provisions.
  2. Extensions of MDD certificates are still issued by NB.  Should your certificate expire somewhere around 2022, an extension may be indicated. The extension, or for that matter any certificate according to the MDD, must be issued by the NB by May 2020.
  3. The NB will not be able to issue a new certificate after the application date. The products are covered by those certificates as long there is no change of intended use or a significant design change.


For class I products:

  1. They must comply with the regulation by May 2020.

MDSS is concerned with the implementation - the lack of resources in the industry and not just with the notified bodies, and other very specific implementing aspects. However, we are particularly worried in regards to:

  1. Products of risk class I.
  2. Products, which were previously not covered by the MDD, but now need to be certified due to the extended scope of the MDR.
  3. Products of previously class I, which now need to be certified by May 2020. Those are:

a. Risk class I reusable instruments.

b. A lot of software due to the new software classification rule.

c... any other product being class I under the MDD and now of a higher risk class (possibly substances and products including nanomaterial).


Those products under point 2 and 3 need to be certified and will face the NB shortage.  Our advice is: GET IN CONTACT WITH A NB OR WITH YOUR NB TO DISCUSS THE MDR CERTIFICATION PLAN…NOW!


A great concern for us are the manufacturers who only have risk class I products in their portfolio. They have not been exposed to a mandatory quality system or any third party review.  In addition, in their home countries, not much control was applied either (i.e. in the USA they may also be FDA exempt). The reason is simply that they do not pose a lot of risk.

The particular concern is that those risk class I products may not be able to comply on time, due to the extensive technical file and quality system requirements that apply for these risk class I products just as they apply for the highest risk class products. Article 10 outlines those requirements, and that article does not distinguish between risk classes!!!  Act now!



The lowest risk class products need to fully comply earlier than the highest risk class products!  ‘Great job, lawmaker!’ - a patient may say when he has to wait for his low risk class product due to administrative delay.

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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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