This policy relates to potential or current customers of Scarlet (see ISO/IEC 17021-1:2015, IAF MD9:2017, Regulation (EU) 920/2013; Annex I [as modified by Part 2 of Schedule 2A to The Medical Devices Regulations 2002]; 3.1.b).
This information is publicly available at the following link.
Scarlet provides ISO 13485:2016 and Directive 93/42/EEC [as modified by Part 2 of Schedule 2A to The Medical Devices Regulations 2002]; Annex II conformity assessment services. This document sets out relevant information regarding some of the processes related to those services.
Scarlet operates in the European Union and in the United Kingdom.
English is the only language used to interact with Scarlet.
In the application form, you can choose between different conformity assessment paths:
More detail on these paths is given in the following sections.
After successful conformity assessment, you will be certified according to ISO 138545:2016 - Medical devices - Quality management systems - Requirements for regulatory purpose. This does not allow you to put your medical device on the European market and is addressed to customers that are only seeking ISO 13845:2016 certification.
This conformity assessment path is addressed to customers seeking to sell their device in Europe. These chapters are relevant to devices with the following risk classes: Class Im, Class IIa, Class IIb, Class III.
Class I device with measuring function manufacturers should apply for this conformity assessment and during the application describe their device. It has to be noted that class Im devices (after risk class assessment and acceptance from Scarlet) will only be assessed on the aspects relating to the conformity of the devices with the metrological requirements, hence Scarlet's involvement in the conformity assessment will be limited to these aspects.
Devices ranging from class IIa to III should as well apply for Regulation (EU) 2017/745 on Medical Devices Annex IX Chapter II assessment in order to obtain a certificate.
This conformity assessment path is addressed to customers with devices ranging from class IIa to class III. this assessment path will assess the technical documentation of the device based on the class of the device.
This conformity assessment path is addressed to customers seeking a UKCA marking in the United Kingdom of Great Britain. This conformity assessment path is addressed to devices ranging from class I with measuring function to III.
The certification of class I with measuring function consists of the following:
This assumes the organisation does not currently hold a ISO 13485:2016 certificate.
The total certification cycle is 5 years.
Explanations for the different types of audits are provided in the sections below.
The total certification cycle is 3 years.
Once a contract for ISO 13485:2016 certification services has been agreed between Scarlet and an customer, a stage 1 audit is performed. A stage 1 audit is an initial assessment of the state of the customer's quality management system and the customer's readiness for a stage 2 audit. Following a stage 1 audit, Scarlet will prepare an audit report summarising the findings. Based on the findings, Scarlet may either recommend that the customer proceeds to a stage 2 audit (subject to identified nonconformities being addressed appropriately), or that the customer repeats the stage 1 audit once further progress has been made.
A stage 2 audit is a further assessment of the customer's quality management system and its alignment with the applicable standard and regulations. During a stage 2 audit, Scarlet's auditors will evaluate the quality management system's adequacy and effectiveness. Following a stage 2 audit, Scarlet will prepare an audit report summarising the findings. Based on the findings, Scarlet may either grant certification of the quality management system (subject to identified nonconformities being addressed appropriately), or refuse to grant certification. If certification is granted, the customer will be issued a certificate from Scarlet. If certification is refused, the justification for refusal will be explained to the customer.
Once the customer's quality management system has been certified after a successful stage 2 audit, the customer enters a 3-year certification cycle ISO 13485:2016 and 5-year for Directive 93/42/EEC [as modified by Part 2 of Schedule 2A to The Medical Devices Regulations 2002]; Annex II certification. During the cycle, two surveillance audits will be carried out in 12 month intervals. Surveillance audits are similar in nature and scope to stage 2 audits. Following each surveillance audit, Scarlet will prepare an audit report summarising the findings. Based on the findings, Scarlet may either recommend continuation of the certification cycle (subject to identified nonconformities being addressed appropriately), or suspend the customer's certificate. Further information regarding suspension of certificates is provided below.
As the customer's certificate nears expiry, a recertification audit is carried out. Recertification audits are similar in nature and scope to stage 2 audits. Following a recertification audit, Scarlet will prepare an audit report summarising the findings. Based on the findings throughout the audit cycle, Scarlet may either recommend renewal of the certificate (subject to identified nonconformities being addressed appropriately), or refuse to renew the customer's certificate.
Scarlet suspends certification in such circumstances as:
Under suspension, the customer's certificate is temporarily invalid.
Scarlet will restore the suspended certification if the issue that has resulted in the suspension has been resolved. Failure to resolve the issues that have resulted in the suspension in a time established by Scarlet will result in withdrawal or reduction of the scope of certification.
In cases where the customer has persistently or seriously failed to meet the certification requirements for certain parts of the scope of certification, Scarlet will reduce the customer's scope of certification to exclude the parts not meeting the requirements. Any such reduction shall be in line with the requirements of the applicable regulation or standard.
Scarlet will notify any applicable recognising competent authorities of the action taken against the certificate.
Requests for information, complaints and appeals can be submitted via the following link.
In the event of a client wishing to appeal against any decision Scarlet, the client shall do so within 14 days of receiving the decision. An investigation will be conducted, the results of which will be shared within 30 days of receiving the appeal. If the client is not happy with the decision of the investigation, the client can forward the appeal to the Scarlet Governing Board. A meeting of the Appeals Panel will be summoned, which shall be held within 30 days of receipt of such notice. The original decision of Scarlet shall stand pending the meeting of the Appeals Panel. At the meeting both the appellant and Scarlet shall be entitled to be heard in confidence. The decision of the Appeals Panel shall be final and any associated correction or corrective action shall be carried out by Scarlet or the appellant. Submission, investigation and decision on appeals shall not result in any discriminatory action being taken against the appellant. The panel appointed in respect of each appeal shall consist of a at least two members, none of whom shall have any direct commercial interest in the subject of the appeal.
Scarlet is committed to maintaining the highest levels of impartiality. Scarlet follows the requirements set out in applicable standards, regulation and guidance, and has appointed an impartiality panel intended to safeguard Scarlet's impartiality.
Scarlet is committed to remaining free of discrimination in the submission, investigation, and decision on appeals and complaints.
Scarlet's marks (as shown in Appendix 1) and CE markings (as shown in Appendix 2) are only permitted for use by customers whose quality management system has a valid certificate issued by Scarlet. The use of the marks is subject to the below conditions and further conditions specified in the contract for certification services agreed between Scarlet and the customer.