Authorized Representative Services
  • MDSS News & Events

    MDSS News & Views

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

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

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
MDSS GmbH

Schiffgraben 41
30175 Hannover
Germany

Share

We use cookies and other tracking technologies to improve your browsing experience on our website, to analyze our website traffic, and to understand where our visitors are coming from. By browsing our website, you consent to our use of cookies and other tracking technologies.