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Second Corrigendum to the MDR and IVDR

This update gives certain Class I manufacturer a break.  



On December 27 the second corrigendum was published in the official Journal of the EU. This update was indeed needed, otherwise with the lack of notified bodies (NB) the European health care system would have fallen apart. This update is a great relief for everyone. Certainly in particular for manufacturers who are directly affected by this. Here is the wording which does the magic:


On page  89, Article 120(3):
for:
‘3.   By way of derogation from Article  5 of this Regulation, a device with a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and which is valid by virtue of paragraph  2 of this Article may only be placed on the market or put into service provided that from the date of application of this Regulation it continues …’,
read:
‘3.   By way of derogation from Article  5 of this Regulation, a device which is a class I device pursuant to Directive 93/42/EEC, for which the declaration of conformity was drawn up prior to 26 May 2020 and for which the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body, or which has a certificate that was issued in accordance with Directive 90/385/EEC or Directive 93/42/EEC and that is valid by virtue of paragraph  2 of this Article, may be placed on the market or put into service until 26 May 2024, provided that from 26 May 2020 it continues …’.

In other words: All products of risk class I according to the MDD, which will have to be reclassified under the MDR to higher risk class and all risk class I reusable surgical instruments which stay class I but will need to involve a NB according to the MDR can be placed on the market until 2024 with complying to the MDD. A certification is not needed until then! However, please keep in mind that certain aspects of the MDR must be implemented. For example the vigilance according to the MDR. Please refer to the details of the MDR Article 120!



WARNING:
All other risk class I products must comply to the MDR by May 2020!! How funny!  The products with the lowest risk portfolio need to comply to the most stringent regulation first!! This update should have allowed those products as well for the extension. Laws sometimes take an interesting direction.


Just one detail to this corrigendum. It actually changes the regulation and this should not be possible via a corrigendum. A corrigendum normally crosses the ts and adds the dots.  There are other minor changes, which we have not reviewed. All the changes need to be assessed by the manufacturer to verify that this does not have an impact on you. The first corrigendum as well provided for some surprises and in fact impacted the requirements significantly. Someone could argue that those were not only Ts and dots.



Certainly as soon the consolidated version is available it is recommended to update your library.

Corrigendum to Regulation (EU) 2017:745.pdf

Corrigendum to Regulation (EU) 2017:746.pdf

Categories: News

MDR Transition!

Plan with your EC REP to get your products ready to market by May 2020. The deadline is approaching quickly and EC REPs resources need to be allocated. Clients submitted their MDR transition plans considering as well the MDSS resources to perform the tasks required under the MDR. Certainly the new MDR contract is the basis for starting this process. The EC REP MDD contract is not sufficient for the MDR compliance. The MDR disappointed some clients who  believed a SIMPLE UPDATE will do it.

Please contact your account administrator at MDSS who will take care of you!

Categories: News

New Guidance published by the Commission!

The  two  new  Regulations  on  medical  devices  745/2017 (MDR) and  746/2017  (IVDR)(hereafter called the Medical DevicesRegulations) have been adopted and entered into force on 25 May 2017. The two Regulations, which are to replace three EU Directives, apply progressively until May 2020 for medical devices and May 2022 for in vitro diagnostic medical devices. Among the many novelties introduced, the two  Regulations enhance the focus of legislators on ensuring that devices placed on the EU market are fit for the new technological challenges linked to cybersecurity risks. In this respect, the new texts lay down certain new essential safety requirements for all  medical devices that incorporate electronic programmable systems and software that  are medical devices in themselves. They require manufacturers to develop and manufacture their products in accordance with the state of the art taking into account the principles of risk management, including information security, as well as to set out  minimum requirements concerning IT security measures, including protection against unauthorised access.

Read the compete document here. Please leave your comment/opinion below whether the document helpful for your MDR endeavor.

Categories: News

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

New Vigilance documents published on the European Commission website!

The following important vigilance documents have been published on the European website:

The new Manufacturer’s Incident Report (MIR) Form has been updated and a copy of the latest version (version 7.2) and detailed guidance/ help text that may assist in completing the form are available on the Commission website.


Based on the additional guidance on the MEDDEV 2.12/1 rev.8  section 4, the current version of the MIR Form included a number of new concepts:

  • The information is presented in a new structure.
  • Introduces international IMDRF coding/ terminology.
  • Introduces a definition of similar incidents and requires similar incidents trend data in a tabular format.
  • In preparation for the future EU MDR it also introduces (not mandatory yet):
    • the concept of SRN which will be utilized greatly in the future under the new regulations.
    • the use of UDI.


The updated version of the MIR Form V 7.2 will become mandatory from January 2020.

However, if you are a manufacturer and have already adapted your IT system to version 7.1, you may use this version until the end of March 2020.


For more detailed information, please do not hesitate to contact your MDSS team!

Categories: News

European Commission offers Guidance on UDIs!

Last Wednesday, the 4th of December 2019, the European Commission released new documents related to the technical specifications for unique device identifiers (UDIs).

Categories: News

Total excitement on social media because of MDR Corrigendum!

In Europe the regulatory community follows closely the latest MDR developments. The rumors, that certain class I products may receive a significant extension, was substantiated last week with the proposal of a second corrigendum. It still may need to go through the Parliament but it passed another hurdle. The regulatory community got all excited and information on social media exploded (we are on LinkedIn - please feel free to connect!).

The Parliament Committee on the Environment, Public Health and Food Safety voted in favor of the corrigendum. Here for the record is the vote! Go to 11:33:30 to see the vote and also the serious comment made.

This provides a great relief for risk class I products that will need the involvement of a Notified Body under the MDR. The products may be placed on the market until May 2024. Please note, certain conditions apply.



Final voting has to go via the Parliament. Let us hope for the best!



28-11-2019

Possibly 4 more years for class I products which must be certified under the MDR (e.g. reusable surgical instruments (Ir), software or substances). The second corrigendum has been published and it is up for final approval. Everything is possible.



Let’s hope for the best!

Second Corrigendum to the MDR

Categories: News

NO INDEPENDENT UK RESPONSIBLE PERSON (RP) POSSIBLE!!!


Brexit and Medical Devices

UK RESPONSIBLE PERSON = IMPORTER



What we already evaluated was strongly confirmed by a representative of the UK MHRA.  

And more importantly it was stated that no independent UK RP is possible.

Please see the latest UK law here to verify this for yourself. In order to come to that conclusion, someone should not only read the requirements for the UK RP (schedule 77). In particular, the definitions for importer, UK RP and the definition for placing products on the market are needed. Then by nature the importer is placing products from a third country on the UK market, and in Schedule 95 states: “… the person placing products on the market is to be regarded as the UK responsible person…”


It was indeed intended that the importer is the UK RP, without leaving the possibility for an independent service provider to take over this role.


This will not only change the regulatory landscape significantly, but more importantly, the overall business approach to selling products in the UK needs to be thoroughly reviewed.  


For example, the importer (your distributor, your precious customer) is now the UK RP and shall act on your behalf, with you being the manufacturer. However, the interest of a distributor may NOT coincide with the interest of the manufacturer. It starts already with the pricing, and how often was it necessary to change the distributor because you were not happy with their performance or demands?


It was clearly indicated that the manufacturer should act in order to prepare for this Brexit situation, but it was confirmed that the time line  for implementing will be granted (4, 8 and 12 month).


A more thorough evaluation will follow shortly, and there is only one really safe solution to secure the business. However, these are not only regulatory decisions any longer. This is now an overall business aspect. This means other departments of the company must be informed and should participate in the discussion - NOW.


Please contact MDSS for further details and the possible solution on this scenario. Our office in the UK could support your solution.  


Brexit scenarios:

  1. Brexit without a deal on October 31, 2019.

  2. Further extension for a few weeks or until January 2020 and then Brexit without a deal.

  3. Further extension with a deal. Transition until December 31, 2020 and then:

a. No agreement with the EU

b. Agreement with the EU and then:

i. Existing law as referenced above (only trade agreement but no Mutual recognition agreement (MRA) of approvals)

ii.New law and MRA.


And certainly, anything else may as well be possible.  


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

Free of charge MDR Authority meeting!

As it seems the Authority of Denmark is concerned with the MDR and provides guidance on the new Regulation.


Obtain a detailed guidance for the upcoming changes. As well as Guidance about requirements and processes regarding applications for clinical investigations in regard to specific products as well as general regulations about CE marking. The Danish Medicines Agency offers 1 hour meeting regarding regulatory advice in English.

Schedule a meeting with the Danish Competent Authority free of charge!

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

Brexit - Again!

If you come form the latest Brexit news here is the link back to the article you were reading.

UK Responsible Person = Importer with severe additional responsibilities


The MDSS solution:
Have MDSS set up an appointment with you to receive the solution for your individual business. A solution, which may also be extremely appealing to your distributor.


The UK authority (MHRA) published a new guidance on the UK responsible person (UK RP). MDSS, together with its clients, evaluated early on (during the drafting of the contract) that the UK RP is actually a new concept and can only be compared with the European Union (EU) Medical Device Regulation (MDR) Authorized Representative (AR) in some specific tasks. The standard AR contract is not sufficient. The new proposed UK law has something different in mind for an entity supporting out of the UK based manufacturers in terms of their compliance. As it seems, legal and liability ramifications play a key role. The new MHRA guidance tries to clarify this now.

Key aspects:

  • Clarification of UK RP responsibilities

  • The importer is the UK RP!

  • Announcement of grace period for the implementation of the UK RP

  • MDSS specialized service towards its clients to cope with the new requirements

The MHRA guideline states: „If you are a UK-based importer and you wish to place a device on the market, you must have the authority from the manufacturer before doing so. This means that you will become a UK Responsible Person.”

This then means that the UK Importer being the UK RP:

  • Must have a “letter of designation” from the Manufacturer

  • May be a person or a legal entity

  • Performs product registration

  • Pays the product registration fees

  • “Acts on behalf of the manufacturer established outside the UK”

  • Must take over specified tasks with regards to the manufacturer’s obligation under these regulations such as:

    • Performs verification of the technical documentation and other documents similar to the MDR Authorized Representative

    • Keeps available a copy of certain documents including the technical file for inspections by the MHRA

    • Fulfills other tasks similar to the MDR Authorized Representative

There are great concerns with the new proposed laws. As one UK entity already stated, they may not be able to buy any longer the product. His fear is that the purchase is of such a low volume and, therefore, not worthwhile for his supplier (manufacturer abroad) to entertain that business any longer with the increased scrutiny. Also, selecting a new supplier for him is now so burdensome that he may accept prices he normally would not! He preferably would now receive his product from a UK manufacturer.

As the manufacturer abroad:

  • Be aware that each individual distributor of yours will automatically be the UK RP. By nature, they are the importer of your products and place the product on the UK market. 
  • You will have to designate them to be the UK RP if you want to continue business with them.
  • You will have to give them a similar mandate as the MDR AR.
  • You will have to trust them with your technical file and other information.


It is not clear why the law actually specifies a UK responsible person. It would have been sufficient to simply impose the requirements on the Importer directly without defining a new term. However, due to the structure provided in the law, by reading the specific UK RP requirements only, someone could come to the conclusion that an independent UK RP is envisioned.

Therefore, the initial MHRA guidance indeed gave the pronounced impression that a manufacturer abroad should designate a UK RP:

- Independent of the importer and
- being a single UK RP

The new MHRA guidance clarifies that the importer is the UK RP (see above) but still suggests installing an independent UK RP. There may be solutions for this requirement with the statement: “Whilst there is no existing list of UK Responsible Persons, you may wish to speak to existing EU Authorized Representatives to determine whether they will be offering services as a UK Responsible Person.”



Does it make sense for your AR to offer such a service? The customers (UK Importer = UK RP) of the manufacturer are automatically the UK RPs! Furthermore, does your AR normally sell your products? The manufacturer specifically selected an AR not being engaged with the sales/import of the products. However, the guidance seems to indicate that the MHRA would like to see a professional UK RP implemented to take over these nontrivial UK RP tasks and that they may have a solution in mind for these new requirements. However, that solution is not outlined in the guidance.


In case of a hard Brexit (Brexit without a deal), the manufacturer will have the time to install such an agreement within the timeframe as outlined for the registration. The guidance states in regards to the timeline:

„The requirement for a manufacturer to have in place a UK Responsible Person is in line with the grace period for registering your devices with the MHRA. Details of the grace period for registrations is set out in our guidance on registrations. Therefore, you must ensure that you are designated as a UK Responsible Person by the time you register with the MHRA.”


With the importer automatically being the UK RP, it actually should read that the UK Importer must implement the requirements of the UK RP and, therefore, must ask his supplier (the manufacturer abroad) to allow him the sales (placing on the market) of the products and that he is allowed to act on his behalf etc... It is up to the manufacturer whether he will conduct now business in the UK with such requirements.  


The grace period is 4, 8 and 12 month and it depends on the classification of the products with the highest classification being the shortest and so on.

There seems to be a different understanding in the guideline in terms of the registration. It is stated that “the UK RP will then assume the responsibilities of the manufacturer in terms of registering the device”. However, the law outlines the “Registration of persons placing general devices on the market” and that is by nature the UK manufacturer or the UK Importer. The requirements for that person among other aspects:

“supplies the Secretary of State with a description of the relevant device; and
pays to the Secretary of State the relevant fee in accordance with regulation 53.”


Our overall impression of the new UK law is that the UK is very UK centered and that there is actually no responsibility for the manufacturer if not located in the UK. The Importer must ensure that he purchases products that comply with the UK law (for the time being CE marked products), must register the products and defend your products because he is the entity facing severe consequences. Legal as well as product liability are aspects the importer faces! The product liability is by nature bestowed upon the legal entity who places the products on the market and the legal concerns are directly outlined in the UK Law.

“(3) A UK responsible person—
may be proceeded against as a person placing the device on the market for the purposes of these regulations;
…”

For a manufacturer abroad, considering the above, there is nothing to be gained to install an independent UK RP.  
Therefore, the motivation to install an independent UK RP may fade significantly by the manufacturer.  



We are of the opinion that both entities, the manufacturer abroad and the Importer may not be content with the requirement.  We suggest a specific solution, which may be agreeable with your customer (the UK Importer).



The MDSS solution:
Have MDSS set up an appointment with you to receive the solution for your individual business. A solution, which may also be extremely appealing to your distributor.


We strongly recommend to evaluate the actual law which can found here.



The guidance on the UK responsible person can be found here.


If you come form the latest Brexit news here is the link back to the article you were reading.

Categories: News

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

Categories: News

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.

Categories: News

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.

Categories: News

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


Categories: News

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.


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

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...

Categories: News
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