🇵🇹 Portugal IVD regulatory data

EU device-registration data distinguish trade name from model/reference/catalogue number. A new UDI-DI is required for listed changes including device name/trade name or version/model where the applicable UDI rules are triggered; a REF edit is not automatically a new UDI. Changes to actor information must be updated within one week under MDR Article 31 or IVDR Article 28, and UDI-database changes not requiring a new UDI-DI within thirty days under Annex VI Part C 5.8.

INFARMED instructs manufacturers/representatives and distributors using the applicable SIDM pathways to reuse EUDAMED identity by UDI-DI/EUDAMED ID and upload labelling, instructions and the declaration. Existing SIDM records must be updated to align with EUDAMED; the current FAQ describes the CDM-to-UDI-DI association while retaining existing documents. A CDM, UDI-DI and the manufacturer’s commercial REF are different identifiers.

INFARMED’s current registration page expressly retains Decreto-Lei 189/2000 Article 12 for IVD distributors. That provision identifies the distributor and legal address, product list with brand/model/version and the required product/documentation particulars. Apply the current SIDM instructions and keep changed identity and device records aligned with EUDAMED; this retained national duty does not reinstate superseded IVDD conformity-assessment routes.

INFARMED requires labels and instructions for use of IVDs to be written in Portuguese, legible and indelible, regardless of whether use is professional, without prejudice to other languages also being included.

For MDR devices and IVDR IVDs, the EU declaration of conformity must be kept current. Its Annex IV identity includes the manufacturer and, where relevant, authorised representative, registered place of business, Basic UDI-DI and traceable product/trade name or product-code information. The label must identify the responsible manufacturer and its registered business address and the authorised representative where required. Update the affected declaration and supplied information when these particulars change.

The amended MDR Article 120(4) and IVDR Article 110(4) allow the specified devices lawfully placed under the former Directives or applicable transition provisions to continue to be made available or put into service. This is conditional on lawful placement of the actual units; it is not permission to place new nonconforming units, to keep an inaccurate post-change manufacturer identity, or to apply a universal old-label grace period.

INFARMED’s free-sale certificate service is for national manufacturers or authorised representatives exporting outside the EU. Request it through the current SIDM route using the applicable regulatory category and device data; one certificate covers devices under the same regulatory diploma. The certificate records the market position on its issue date rather than having a fixed expiry. The published charge is EUR 30.69 for up to four sheets and EUR 15.35 per additional set of up to four; payment cannot be reused or transferred.

EU device-registration data distinguish trade name from model/reference/catalogue number. A new UDI-DI is required for listed changes including device name/trade name or version/model where the applicable UDI rules are triggered; a REF edit is not automatically a new UDI. Changes to actor information must be updated within one week under MDR Article 31 or IVDR Article 28, and UDI-database changes not requiring a new UDI-DI within thirty days under Annex VI Part C 5.8.

MDCG 2022-6 treats administrative changes to manufacturer name, address, legal form or representative as generally not changes to design or intended purpose; agreed notified-body/QMS notification remains applicable. This significance test does not by itself authorise assignment of a certificate or portfolio to a new manufacturer. Establish the continuing legal person, certificate scope and current IVDR transition eligibility.

INFARMED instructs manufacturers/representatives and distributors using the applicable SIDM pathways to reuse EUDAMED identity by UDI-DI/EUDAMED ID and upload labelling, instructions and the declaration. Existing SIDM records must be updated to align with EUDAMED; the current FAQ describes the CDM-to-UDI-DI association while retaining existing documents. A CDM, UDI-DI and the manufacturer’s commercial REF are different identifiers.

INFARMED’s current registration page expressly retains Decreto-Lei 189/2000 Article 12 for IVD distributors. That provision identifies the distributor and legal address, product list with brand/model/version and the required product/documentation particulars. Apply the current SIDM instructions and keep changed identity and device records aligned with EUDAMED; this retained national duty does not reinstate superseded IVDD conformity-assessment routes.

For MDR devices and IVDR IVDs, the EU declaration of conformity must be kept current. Its Annex IV identity includes the manufacturer and, where relevant, authorised representative, registered place of business, Basic UDI-DI and traceable product/trade name or product-code information. The label must identify the responsible manufacturer and its registered business address and the authorised representative where required. Update the affected declaration and supplied information when these particulars change.

The amended MDR Article 120(4) and IVDR Article 110(4) allow the specified devices lawfully placed under the former Directives or applicable transition provisions to continue to be made available or put into service. This is conditional on lawful placement of the actual units; it is not permission to place new nonconforming units, to keep an inaccurate post-change manufacturer identity, or to apply a universal old-label grace period.

INFARMED’s free-sale certificate service is for national manufacturers or authorised representatives exporting outside the EU. Request it through the current SIDM route using the applicable regulatory category and device data; one certificate covers devices under the same regulatory diploma. The certificate records the market position on its issue date rather than having a fixed expiry. The published charge is EUR 30.69 for up to four sheets and EUR 15.35 per additional set of up to four; payment cannot be reused or transferred.

INFARMED requires labels and instructions for use of IVDs to be written in Portuguese, legible and indelible, regardless of whether use is professional, without prejudice to other languages also being included.

EU device-registration data distinguish trade name from model/reference/catalogue number. A new UDI-DI is required for listed changes including device name/trade name or version/model where the applicable UDI rules are triggered; a REF edit is not automatically a new UDI. Changes to actor information must be updated within one week under MDR Article 31 or IVDR Article 28, and UDI-database changes not requiring a new UDI-DI within thirty days under Annex VI Part C 5.8.

MDCG 2022-6 treats administrative changes to manufacturer name, address, legal form or representative as generally not changes to design or intended purpose; agreed notified-body/QMS notification remains applicable. This significance test does not by itself authorise assignment of a certificate or portfolio to a new manufacturer. Establish the continuing legal person, certificate scope and current IVDR transition eligibility.

INFARMED instructs manufacturers/representatives and distributors using the applicable SIDM pathways to reuse EUDAMED identity by UDI-DI/EUDAMED ID and upload labelling, instructions and the declaration. Existing SIDM records must be updated to align with EUDAMED; the current FAQ describes the CDM-to-UDI-DI association while retaining existing documents. A CDM, UDI-DI and the manufacturer’s commercial REF are different identifiers.

INFARMED’s current registration page expressly retains Decreto-Lei 189/2000 Article 12 for IVD distributors. That provision identifies the distributor and legal address, product list with brand/model/version and the required product/documentation particulars. Apply the current SIDM instructions and keep changed identity and device records aligned with EUDAMED; this retained national duty does not reinstate superseded IVDD conformity-assessment routes.

For MDR devices and IVDR IVDs, the EU declaration of conformity must be kept current. Its Annex IV identity includes the manufacturer and, where relevant, authorised representative, registered place of business, Basic UDI-DI and traceable product/trade name or product-code information. The label must identify the responsible manufacturer and its registered business address and the authorised representative where required. Update the affected declaration and supplied information when these particulars change.

The amended MDR Article 120(4) and IVDR Article 110(4) allow the specified devices lawfully placed under the former Directives or applicable transition provisions to continue to be made available or put into service. This is conditional on lawful placement of the actual units; it is not permission to place new nonconforming units, to keep an inaccurate post-change manufacturer identity, or to apply a universal old-label grace period.

INFARMED’s free-sale certificate service is for national manufacturers or authorised representatives exporting outside the EU. Request it through the current SIDM route using the applicable regulatory category and device data; one certificate covers devices under the same regulatory diploma. The certificate records the market position on its issue date rather than having a fixed expiry. The published charge is EUR 30.69 for up to four sheets and EUR 15.35 per additional set of up to four; payment cannot be reused or transferred.

INFARMED requires labels and instructions for use of IVDs to be written in Portuguese, legible and indelible, regardless of whether use is professional, without prejudice to other languages also being included.

EU device-registration data distinguish trade name from model/reference/catalogue number. A new UDI-DI is required for listed changes including device name/trade name or version/model where the applicable UDI rules are triggered; a REF edit is not automatically a new UDI. Changes to actor information must be updated within one week under MDR Article 31 or IVDR Article 28, and UDI-database changes not requiring a new UDI-DI within thirty days under Annex VI Part C 5.8.

INFARMED instructs manufacturers/representatives and distributors using the applicable SIDM pathways to reuse EUDAMED identity by UDI-DI/EUDAMED ID and upload labelling, instructions and the declaration. Existing SIDM records must be updated to align with EUDAMED; the current FAQ describes the CDM-to-UDI-DI association while retaining existing documents. A CDM, UDI-DI and the manufacturer’s commercial REF are different identifiers.

INFARMED’s current registration page expressly retains Decreto-Lei 189/2000 Article 12 for IVD distributors. That provision identifies the distributor and legal address, product list with brand/model/version and the required product/documentation particulars. Apply the current SIDM instructions and keep changed identity and device records aligned with EUDAMED; this retained national duty does not reinstate superseded IVDD conformity-assessment routes.

For MDR devices and IVDR IVDs, the EU declaration of conformity must be kept current. Its Annex IV identity includes the manufacturer and, where relevant, authorised representative, registered place of business, Basic UDI-DI and traceable product/trade name or product-code information. The label must identify the responsible manufacturer and its registered business address and the authorised representative where required. Update the affected declaration and supplied information when these particulars change.

The amended MDR Article 120(4) and IVDR Article 110(4) allow the specified devices lawfully placed under the former Directives or applicable transition provisions to continue to be made available or put into service. This is conditional on lawful placement of the actual units; it is not permission to place new nonconforming units, to keep an inaccurate post-change manufacturer identity, or to apply a universal old-label grace period.

INFARMED’s free-sale certificate service is for national manufacturers or authorised representatives exporting outside the EU. Request it through the current SIDM route using the applicable regulatory category and device data; one certificate covers devices under the same regulatory diploma. The certificate records the market position on its issue date rather than having a fixed expiry. The published charge is EUR 30.69 for up to four sheets and EUR 15.35 per additional set of up to four; payment cannot be reused or transferred.

INFARMED requires labels and instructions for use of IVDs to be written in Portuguese, legible and indelible, regardless of whether use is professional, without prejudice to other languages also being included.

EU device-registration data distinguish trade name from model/reference/catalogue number. A new UDI-DI is required for listed changes including device name/trade name or version/model where the applicable UDI rules are triggered; a REF edit is not automatically a new UDI. Changes to actor information must be updated within one week under MDR Article 31 or IVDR Article 28, and UDI-database changes not requiring a new UDI-DI within thirty days under Annex VI Part C 5.8.

A distributor, importer or other person that markets a device under its own name or trademark generally assumes the manufacturer obligations, subject to the agreement exception that keeps the original manufacturer identified and responsible on the label. Changing intended purpose or making a modification that may affect conformity has separate manufacturer-role consequences. The conditional translation/repackaging activities in Article 16(2) are exceptions, not automatic legal-manufacturer transfers.

Where the authorised representative changes, the agreement must address termination/start dates, the date until which the outgoing representative may appear in manufacturer-supplied information, transfer of documents and property/confidentiality, and forwarding of complaints and incidents by the outgoing representative. This is the Article 12 representative handover rule; it does not assign a foreign manufacturer’s certificate or device portfolio to a new legal manufacturer.

MDCG 2022-6 treats administrative changes to manufacturer name, address, legal form or representative as generally not changes to design or intended purpose; agreed notified-body/QMS notification remains applicable. This significance test does not by itself authorise assignment of a certificate or portfolio to a new manufacturer. Establish the continuing legal person, certificate scope and current IVDR transition eligibility.

INFARMED instructs manufacturers/representatives and distributors using the applicable SIDM pathways to reuse EUDAMED identity by UDI-DI/EUDAMED ID and upload labelling, instructions and the declaration. Existing SIDM records must be updated to align with EUDAMED; the current FAQ describes the CDM-to-UDI-DI association while retaining existing documents. A CDM, UDI-DI and the manufacturer’s commercial REF are different identifiers.

INFARMED’s current registration page expressly retains Decreto-Lei 189/2000 Article 12 for IVD distributors. That provision identifies the distributor and legal address, product list with brand/model/version and the required product/documentation particulars. Apply the current SIDM instructions and keep changed identity and device records aligned with EUDAMED; this retained national duty does not reinstate superseded IVDD conformity-assessment routes.

For MDR devices and IVDR IVDs, the EU declaration of conformity must be kept current. Its Annex IV identity includes the manufacturer and, where relevant, authorised representative, registered place of business, Basic UDI-DI and traceable product/trade name or product-code information. The label must identify the responsible manufacturer and its registered business address and the authorised representative where required. Update the affected declaration and supplied information when these particulars change.

The amended MDR Article 120(4) and IVDR Article 110(4) allow the specified devices lawfully placed under the former Directives or applicable transition provisions to continue to be made available or put into service. This is conditional on lawful placement of the actual units; it is not permission to place new nonconforming units, to keep an inaccurate post-change manufacturer identity, or to apply a universal old-label grace period.

INFARMED’s free-sale certificate service is for national manufacturers or authorised representatives exporting outside the EU. Request it through the current SIDM route using the applicable regulatory category and device data; one certificate covers devices under the same regulatory diploma. The certificate records the market position on its issue date rather than having a fixed expiry. The published charge is EUR 30.69 for up to four sheets and EUR 15.35 per additional set of up to four; payment cannot be reused or transferred.

INFARMED requires labels and instructions for use of IVDs to be written in Portuguese, legible and indelible, regardless of whether use is professional, without prejudice to other languages also being included.

EU device-registration data distinguish trade name from model/reference/catalogue number. A new UDI-DI is required for listed changes including device name/trade name or version/model where the applicable UDI rules are triggered; a REF edit is not automatically a new UDI. Changes to actor information must be updated within one week under MDR Article 31 or IVDR Article 28, and UDI-database changes not requiring a new UDI-DI within thirty days under Annex VI Part C 5.8.

A distributor, importer or other person that markets a device under its own name or trademark generally assumes the manufacturer obligations, subject to the agreement exception that keeps the original manufacturer identified and responsible on the label. Changing intended purpose or making a modification that may affect conformity has separate manufacturer-role consequences. The conditional translation/repackaging activities in Article 16(2) are exceptions, not automatic legal-manufacturer transfers.

Where the authorised representative changes, the agreement must address termination/start dates, the date until which the outgoing representative may appear in manufacturer-supplied information, transfer of documents and property/confidentiality, and forwarding of complaints and incidents by the outgoing representative. This is the Article 12 representative handover rule; it does not assign a foreign manufacturer’s certificate or device portfolio to a new legal manufacturer.

MDCG 2022-6 treats administrative changes to manufacturer name, address, legal form or representative as generally not changes to design or intended purpose; agreed notified-body/QMS notification remains applicable. This significance test does not by itself authorise assignment of a certificate or portfolio to a new manufacturer. Establish the continuing legal person, certificate scope and current IVDR transition eligibility.

INFARMED instructs manufacturers/representatives and distributors using the applicable SIDM pathways to reuse EUDAMED identity by UDI-DI/EUDAMED ID and upload labelling, instructions and the declaration. Existing SIDM records must be updated to align with EUDAMED; the current FAQ describes the CDM-to-UDI-DI association while retaining existing documents. A CDM, UDI-DI and the manufacturer’s commercial REF are different identifiers.

INFARMED’s current registration page expressly retains Decreto-Lei 189/2000 Article 12 for IVD distributors. That provision identifies the distributor and legal address, product list with brand/model/version and the required product/documentation particulars. Apply the current SIDM instructions and keep changed identity and device records aligned with EUDAMED; this retained national duty does not reinstate superseded IVDD conformity-assessment routes.

For MDR devices and IVDR IVDs, the EU declaration of conformity must be kept current. Its Annex IV identity includes the manufacturer and, where relevant, authorised representative, registered place of business, Basic UDI-DI and traceable product/trade name or product-code information. The label must identify the responsible manufacturer and its registered business address and the authorised representative where required. Update the affected declaration and supplied information when these particulars change.

The amended MDR Article 120(4) and IVDR Article 110(4) allow the specified devices lawfully placed under the former Directives or applicable transition provisions to continue to be made available or put into service. This is conditional on lawful placement of the actual units; it is not permission to place new nonconforming units, to keep an inaccurate post-change manufacturer identity, or to apply a universal old-label grace period.

INFARMED’s free-sale certificate service is for national manufacturers or authorised representatives exporting outside the EU. Request it through the current SIDM route using the applicable regulatory category and device data; one certificate covers devices under the same regulatory diploma. The certificate records the market position on its issue date rather than having a fixed expiry. The published charge is EUR 30.69 for up to four sheets and EUR 15.35 per additional set of up to four; payment cannot be reused or transferred.

INFARMED requires labels and instructions for use of IVDs to be written in Portuguese, legible and indelible, regardless of whether use is professional, without prejudice to other languages also being included.