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Local Authorized Representative

Whenever you think of marketing your product in a new market like EU, USA or global markets, if your company does not have a physical location, then you need an Authorized Representative who serves as a liaison between you and the National Health Authorities to comply to the Directives and Regulations. It is possible to nominate a distributor as your Authorized Representative; however, it is not advisable as most distributors are not equipped to execute the mandatory responsibilities of the Authorized Representative. To separate your commercial and regulatory interests, it is not a good idea to appoint a distributor as your Local Authorized Representative

REGULATING MEDICAL DEVICES IN THE POST BREXIT EUROPEAN UNION

Brexit has significantly impacted medical device manufacturers who want to market across the UK, particularly regarding in-country representation. After the UK left the EU on February 1, 2020, a transition period began and a new role as the UK Responsible Person has been created under the UK MDR 2002 (as amended by the UK MDR 2019), a UKRP is a must from January 1, 2021, and the UKRP must register the device manufacturer, any device importers, and the devices with the MHRA. MHRA plans to substitute the CE mark with a UK Conformity Assessment (UKCA) mark; its use is currently expected to become mandatory on June 30, 2023.

EU-based manufacturers selling their medical devices in the remaining 27 EUMember States will need a UK Responsible Person to market their medical devices in the UK. Non-EU manufacturers using EU-based Authorized Representative will require a UK Authorized Representative to market their devices in the UK. Non-EU manufacturers using a UK-based Authorized Representative (AR) will need to appoint a new EU-based Authorized Representative. UK-based manufacturers will become non-EU manufacturers, who will need to appoint an EU based Responsible Person if they want to place medical devices on the EU market.

Our Role

As your Local and Authorized Representative, we act as a link between you and the health Authorities and notified bodies. As an independent organization, MakroCare can act as your regulatory guide and Authorized Representative to assist you to:

  • Register your Medical Device or IVD with HAs or NBs before being placed in the market
  • Review & prepare Technical Documentation (if you need assistance)
  • Maintain a copy of your Technical file available for inspection by the Competent Authorities and protect the confidentiality of your documentation
  • Inform manufacturer about incidents & complaints in the shortest period.
  • Notify Health Authorities of all major incidents pertaining to products when necessary
  • Provide guidance in reporting Incident and Field Safety Corrective Action (FSCA), aligning you with your distributors
  • Support PMS activities

Why MakroCare?

MakroCare developed this service over many years to specifically support the needs of small and medium-sized manufacturers.

  • Experienced consultants, regulatory experts, and auditors who can understandany type of complicated device regulation and respond to any questions or concerns from HA/NB
  • Our experienced consultants with deep experience in Global regulations, registering thousands of devices, enables a best, fast and efficient registration process.
  • We have a global presence and our multiple offices across time zones can ensure a better reach for your products.

 

For More information? Get in touch with us.

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