International product compliance sorted! With help from easyCE.

The product must still meet the destination market’s requirements. Recognition concerns the agreed assessment work; it is not a general exemption from local rules and does not create a universal “MRA certificate”.

The benefit depends on the product, sector and recognised scope. We check those conditions before you commission tests, so your team knows which existing records can be reused and which additional evidence is needed.

Designation is specific to the agreement and technical scope. Accreditation alone does not establish recognition under every MRA, and a body described as “notified” in the EU does not automatically have authority for every overseas assessment. Check the body’s current designation and relevant product coverage.

The existence of an agreement is only the starting point. Confirm that the relevant sector is operational, the product is covered and the assessment body has the required designation. Country-specific arrangements are outlined below.

Select the destination country, check the sectoral annex and confirm the body’s current recognised scope before placing an order. Older agreement titles may use product terminology that has since changed, so the applicable legislation and implementation status also need checking.

Each sector has its own conditions. A reference to a sector does not mean that every product or procedure is currently covered. Check the applicable annex and the designated Australian or EU assessment body through the European Commission’s MRA directory.

The protocol enables recognised bodies to assess conformity against the importing party’s requirements within their designated scope. Product classification, the relevant standards and the required testing or certification route still need to be established. The European Commission’s MRA directory links to the protocol and assessment-body lists.

These are specific arrangements, not general recognition of CE-marked goods. Identify whether your project concerns laboratory study data or the pharmaceutical requirements covered by the relevant agreement before relying on recognition. The European Commission’s MRA directory provides links to both frameworks.

It does not by itself establish compliance with all product legislation, authorise a product for sale or replace a required declaration of conformity. We distinguish the evidence recognised under GLP from the remaining obligations for the finished product.

Their requirements and recognition mechanisms differ. For a product assessment, check the relevant sectoral annex and the current designation of the proposed body through the European Commission’s MRA directory. Recognition in one sector does not extend automatically to another.

Confirm the relevant annex, applicable product requirements and current recognised scope before commissioning assessment work. The European Commission’s MRA directory links to the agreement and assessment bodies designated by New Zealand and the EU Member States.

Coverage must be checked against the current legal framework for the product. In particular, the medical-device chapter has not been updated to cover the EU MDR and IVDR, so it must not be treated as automatic mutual market access for those devices.

Use the European Commission’s MRA directory for the relevant chapter and assessment-body lists, together with Swissmedic’s current medical-device guidance where applicable. Local representation, registration and documentation requirements need their own review.

There is no general acceptance of CE marking as proof that a product meets US requirements. Check the actual operational sector, recognised body and applicable federal, state and workplace requirements for your product. The European Commission’s MRA directory provides the relevant agreement and designation links.

Additional tests, registrations, certification, local representation, markings or translated instructions may be needed. easyCE compares the existing evidence with the destination’s requirements and prepares a practical plan to close the gaps.

It should also not be confused with the EU principle of mutual recognition for goods lawfully marketed in another Member State. That principle concerns goods not fully covered by harmonised EU rules and operates under a different framework.

You receive a defined scope covering the necessary tests, documentation and market-specific actions. Our experts coordinate the agreed work and keep the assessment requirements connected to your product design, so recognition is used where it genuinely helps the project.