What is the practical impact for a medical device manufacturer that has a UK-based Authorized Representative?
This is going to have a huge impact if a manufacturer has their Authorized Representative (EU AR) currently based in the UK.
As indicated in the European Commission notice, there is an Implication of the Brexit is that an UK office based AR will no longer be valid under EU law. We suggest that manufacturers must discuss the situation with their AR. Alternatively, contact a professional (qualified, registered, and has an PRRC in their team) AR service provider.
The significant impact for manufacturers is that all product labeling must identify the Authorized Representative, including their address and contact information. If a company sells thousands of products with a UK AR, the change to labeling alone is a significant impact.
If you are based in the UK, it’s important to remember that we anticipate that as of March 30, 2019, you will need to appoint an EU-based Authorized Representative, and that AR needs to be added and/or updated on your product labeling.
What we do?
We assist manufacturers and consultants by delivering integrated business solutions, which include European Authorized Representative (AR) services (MDR / IVDR) and Legal Representative Services (pharma companies). We act as legal entity towards the European Competent Authorities to ensure all issues will be handled effectively and in compliance of the European requirements.
We representate your company to all member states of the European Union (EU) as required by law: 'Act and to be addressed by authorities and notified bodies in the EU instead of you as manufacturer, with regard to the obligations of the manufacturer under EU Directive, as and when required ‘.
A manufacturer of a medical device or of an in vitro diagnostic device cannot simply have a post office box located in the EU, but is obliged by EU law to appoint an authorized representative to competent authorities. In this way, there is no need to open an office within the EU.
As your EU Authorized Representative (AR) we are legally responsible and accountable for:
- Retention of all technical documentation and certificates so that this can be readily provided to both Competent Authorities (CA) and Notified Bodies (NB)
- Notification and reports concerning Post-Market Clinical Follow-up (PMCF) issues, (i.e. incident reporting, product recalls and Field Safety Corrective Actions (FSCA) to any CA according to the local requirements and to Meddev guidelines in each EU Member state
- Notification of significant changes of your medical device to any CA
- Notification of clinical investigations to any CA
- Maintenance of clinical reports required by any CA
As your EU AR it is required that our contact information must be included in all product related communication materials, such as product labels, IFU, inserts, and manuals.
As your EU AR we
- represent you as a non EU manufacturer to all EU member states, including UK after the Brexit
- submit to the electronic system information as referred to in Annex V (part A) before your medical device is placed on the market and or before applying to a notified body (MDR requirement)
- notify you when your CE-marked medical devices is registered as approved by any Competent Authority
- maintain your technical product documents and files, as required by the MDR (art 9,3)
- provide Competent Authorities all information and documents necessary to demonstrate the conformity of your medical device
- cooperate with the Competent Authority on any corrective action
- notify EU Competent Authorities in case of severe adverse event (SAE) and serious incidents
- interface on your behalf between Competent Authorities, Notified Body and your distributors or end-users
- monitor changes in regulatory requirements and contact you when there are issues that deserve your attention
- perform an annual review of your technical file content to confirm the accuracy of the data
- Co-sign the Declaration of Conformity (DoC)
- support you to arrange covering product liability as required in the MDR
Optional services we can provide may include the following:
- Post market Vigilance and feedback
- Apostille and legalization of Free Sales Certificates (FSC)
- Post market clinical evaluation
- Handling notifications of clinical investigations
- Supply chain control
- Preparations for unannounced audits or inspections
- Product liability insurance
- Risk management
- Logistics solutions
MRM is proud to be a full Associate of EAAR , which stands for Quality, Reliability, and Professionalism.