How to choose an EC REP

How to choose an EC REP

This article on how to choose an EC REP applies to Authorized Representative, Sponsor or Consultant too.

Please click here to access the European commission medical device website and for more information on how to choose an EC REP

1. Cost: Let us face it.  This is the number one factor for most companies. The range could differ a lot between companies, jurisdictions, and type of service provided. Some consultants provide long and complicated agreements with “hidden” costs that are hard to calculate. And some consultants that provide simple to understand agreements with no hidden cost. So reflection of cost on the quotation could be a good indicator when you do your evaluation. However there are agreements that may not reflect all the services provided so it is good thing that you always ask the service provider to let you know what is the full process to attain your objective and is this service covered under the contract? Because you will not know about these hidden costs if you do not know the whole process in the first place! For some reference annual EC REP fee is about 2K EURO (give or take). Hoped that this number helps you have a rough idea on how to choose a good EC REP!
2. Time/ Speed: Now you would not know in reality how fast is the consultant before you engaged them. So here are a few ways to evaluate this. Ask for the lead time to be indicated in the agreement. See how fast the consultant comes back to you on the commercial agreements (and changes). Ask for references. We would not recommend that you reflect a penalty for late delivery as most medical device consultants would reject this because very often the delay is caused by external factors (test lab or authority).
3. Quality: Quality of work is important if the requirements given by the service provider is not clear, it might lead to unnecessary misunderstanding and that would lead to unnecessary effort and delay to lead time too (as per point 2). So it is always good to question your service provider on the necessary details of the project before engaging them. A good service provider would attempt to give a complete picture, explain to you in layman terms to convince you to take their service. Also the fluency of the consultant is important. You might want to call the service provider up to talk to them or least evaluate their quality via their written responses.
4. Conflict of interest: Now this is a more debatable point. Some EC REP would refuse to do the technical documentations when they are appointed as your EC REP. While this sounds good from a moral high ground, often it could be frustrating to work with EC REP that does this. You can imagine that you are in need of urgent CE Marking to your product. However your EC REP might deliberately give you regulatory obstacles without explaining properly on what exactly they are seeking for. A lot of time would be wasted under this exercise. Another more crucial point to take note of is that some local authority might ask you change authorized representative if they find out that the entity that represents you also certify your product.
5. Global experience: Now this is good to have especially if you have trouble understanding the context of certain requirements. For instance, EC REP, Authorized Representative, Registrant, Sponsor, marketing authorized holder, importer could mean the same thing in different countries. A certificate of free sale could also be satisfied via a CFG (from the US). A service provider with global regulatory experience would be able to help you understand the different terminology and context to bring any regulatory project up to speed.
6. Outsource service provider. Now some consultants outsourced their work to other consultants but this is “hidden” from the client. From an globalization perspective, we do not think this would be a big issue. A lot businesses outsourced their work to other companies to promote efficiency. The only thing that we recommend here is that you ensure that the agreement is signed with the service provider and the service provider is ultimately responsible for the quality of work. It is not necessary to try to work directly with the direct service provider directly to get a lower cost. Assigning regulatory work to a reputable service provider is important because in way, it is like insurance and you would want a reputable service provider to be responsible for the success of the project.

Click here to contact us on more information on how to choose an EC REP or Authorized Representative or Sponsor or Consultant. Although CMS has not started global registration service yet, we do have a good idea which consultants are good for which countries.