Supplement to the General Business Conditions of DQS Medizinprodukte GmbH applicable for auditing and certification under EU Regulation 2017/745 - valid from August 2020
Specific conditions for the management system auditing and certification services of DQS Medizinprodukte GmbH, hereinafter referred to as “DQS MED”, with its contracting partner, hereinafter referred to as “client”, applying for auditing and certification under Regulation (EU) 2017/745 of the European Parliament and Council for medical devices (short VO (EU) 2017/745).
1. VO (EU) 2017/745
DQS MED is a notified body for the VO (EU) 2017/745 concerning medical devices (identification number: 0297).
The current statutory regulations as well as the rules for designation of notified bodies apply to the process within the framework of the VO (EU) 2017/745.
a) Review of product documentation
DQS MED reviews the product documentation in accordance with the VO (EU) 2017/745 with the aim to determine the compliance of the product with the essential safety and performance requirements of VO (EU) 2017/745 as well as the compliance with the documentation requirements of the manufacturer. During the review process, both technical and clinical experts will be involved in the task of reviewing the compliance with the underlying specifications and standards. In case of a positive certification decision, the client receives a DQS MED certificate or an extension of its existing certificate.
The documents required or requested for reviewing must be submitted to DQS MED in German or English.
In case of processes according to VO (EU) 2017/745, the client receives an assessment report about the conclusion of the review process as well as a separate certificate about the conducted technical file examination.
During the review, DQS MED is independent, neutral and objective and ensures that the assigned experts are also independent, neutral and objective at the review and adhere to strict confidentiality with regard to information acquired in the context of the review process.
If the device is subject to an assessment under a "Special Additional Procedure" as described in VO (EU) 2017/745 Annex IX Section 5, DQS MED initiates the necessary consultation procedure with a competent authority.
The comments of the competent authorities will be taken into account in the decision of DQS MED in accordance with the requirements of VO (EU) 2017/745.
b) Selection of Assessors
The number and selection of assessors resides with DQS MED (according to certification rules, paragraph 6 "Sector-specific requirements"), subcontracting to others, including DQS offices, is not possible. DQS MED nominates the assessor(s) and provides the client with their professional profile. DQS MED commits itself to assign only assessors who are suitable for the task on the basis of their technical qualifications, their experience and their personal abilities, in particular, the assessor to be appointed is obliged to comply with the relevant requirements of VO (EU) 2017/745 Annex VII. The commissioned assessors and external experts may not subcontract work to other institutions or persons. They are authorized assessors for the underlying standards or specifications and have appropriate experience in the client’s area of operation as well as in management and auditing.
The client is entitled to reject the assessor(s) proposed by DQS MED with appropriate written justification. In such cases, DQS MED will name a replacement for the rejected assessor. This also applies to auditors in the training/qualification. Should an assessor become unavailable immediately before or during the assessment, the two parties shall mutually agree on how to proceed. The procedure in accordance with 3 and 4 remains unaffected hereby.
3. Effectiveness of certified management system
DQS MED verifies the effectiveness of the client’s certified management system by performing regular assessments.
Should DQS MED receive information from third parties which dispute the conformity or effectiveness of a management system it has certified, it is entitled to perform additional, non routine assessments at short notice by informing the client. For processes which come under the VO (EU) 2017/745, DQS MED has the right to perform additional unannounced audits. In the event of assessments for extraordinary reasons and also for unannounced audits, the audit team will be selected with particular diligence due to the fact that the client does not have the opportunity to raise objections against members of the audit team. Costs occurred hereby are borne by the client.
4. Independence of the Assessment
The client is obliged to ensure the independence and impartiality of the DQS MED assessments and certifications in relation to the client prior to receiving these services and to refrain from anything that could affect the independence and impartiality of the DQS MED staff and assessors. This applies in particular to offers of consultancy work, of employment and commissions, both salaried and freelance, to separate agreements regarding fees or other monetary benefits. Should the client become aware of circumstances that compromise, have compromised or could compromise the independence and impartiality of a DQS MED assessment, he is obliged to inform DQS MED about this immediately. DQS MED is obliged to exclude all DQS MED employees and assessors from the certification process in the event that their independence and impartiality are not ensured. The DQS MED Policy on Independence and Impartiality is provided to the client on request.
5. Information obligations of DQS MED as notified body
As notified body for the VO (EU) 2017/745, DQS MED complies with the reporting obligation provisions of VO (EU) 2017/745 article 57. This includes reporting on:
- all issued and amended certificates;
- all declined certifications, with indication of reasons;
- all certificates with extensions and reductions of scope;
- all suspended and reinstated certificates;
- all withdrawn certificates.
Furthermore, notifications are carried out within the scope of conformity assessments and notifications of certificates in accordance with VO (EU) 2017/745 Article 54 section 3 and Article 55 section 1, within the scope of the assessment of the " Short reports safety and clinical performance" in accordance with VO (EU) 2017/745 Article 32 and within the scope of the assessment of the "Periodic Safety Update Reports" in accordance with VO (EU) 2017/745 Article 86. Furthermore, DQS MED as Notified Body allows the competent authorities to inspect all relevant documents of the customer within the scope of their monitoring obligations.
The client’s consent to this is presupposed.
The retention period of records on the activities of DQS MED and the certified customers is fixed at 17 years.
6. Certificates and certification symbols
a) Issuance and use
DQS MED is obliged to issue a certificate and deliver it up to the client upon fulfilment of all certification requirements and contractual obligations. The certification decision is the sole responsibility of DQS MED, subcontracting to others, including DQS offices, is not possible. DQS MED is entitled to define conditions or restrictions regarding the validity of certificates. The validity of certificates is a maximum of 5 years.
The basis is the assessment report including the recommendation of the experts. DQS MED certificates according to VO (EU) 2017/745 have a validity period of five years, commencing at the earliest from the date of establishing the conformity by way of certification decision. Such use is restricted to the scope and the period of validity of the certification. In referring to the certification and in using the certificate symbol, no ambiguity should exist in the conformity symbol or accompanying text regarding what has been certified. DQS MED is obliged within the framework of its possibilities to ensure that correct use is observed. The client commits itself to,
• adhering to the stipulations of DQS MED regarding reference to the certification status in the communication media and the advertising media;
• refraining from making misleading statements regarding its certification or of allowing such statements to take place;
• refraining from using the certification documents or parts thereof in a misleading manner or of allowing such use to take place;
• changing all promotion Material in the event of the scope of the certification being reduced or restricted;
• not permitting the implicit suggestion that the certification activities have validity beyond the area of their scope;
• not in any way using certification in a way which would bring the certification body and/or the certification system into disrepute.
b) Use of the CE mark
The legal specifications for marking a product (CE mark) are to be adhered to by the client
c) Extension of the scope
Should changes occur during the period of validity of a certification, which make it necessary to extend the scope of certificate (e.g., new sites, lines of production and activities), the scope can be extended, if applied for by the client.
The precondition for the extension of scope is the assessment of the effectiveness of the extended quality management system with respect to the specifications of the underlying standard.
d) Reduction of scope
DQS MED is entitled to reduce the scope of the issued certificate in the event that the customer has evidently breached its obligations, especially where,
• an approved medical device no longer meets the essential safety and performance requirements in such a way that patients, users or third parties are exposed to significant risks:
• an approved medical device does not fulfill the intended purpose specified by the manufacturer and the detected defects are not eliminated within the time frame specified by DQS MED;
• an approved medical device is assigned by the regulatory authorities to another class that is not covered by the issued certificate;
• corrective actions to the management system with regard to the respective part of the certification scope have not been evidently and effectively implemented within the agreed timeframe;
• DQS MED has not been immediately informed of changes to the management system and other changes which would influence the management system’s conformity to the underlying standard;
• the preconditions with regard to respective part of the certification scope which led to the issuance of the certificate no longer exist.
Prior to the decision to reduce the scope of certification, the customer will be listened to by DQS MED, unless such a hearing is not possible due to the urgency of the decision to be made.
Initially, the reduction of scope of certification is limited in time. If the necessary corrective actions are evidently and effectively implemented within the time limit set, then the reduction of scope of certification will be rescinded.
After the reduction of the scope of the certification, the customer must immediately cease to use the certificate with regard to the parts which no longer apply and refrain from such use during the whole period of the limited restriction. Subsequent to a final reduction of scope (i.e. beyond the time limit set), the certificate with the reduced scope will be correspondingly revised.
DQS MED is not liable for costs incurred for the customer due to the reduction of certification scope or its consequences
After restriction of the scope of a certification, the client must immediately cease using the certificate with respect to the omitted parts of the scope and refrain from such use during the entire period of the temporary restriction. After final restriction (i.e. after expiry of the time limit), the client's restricted certificate shall be revised accordingly.
DQS MED shall not be liable for any costs incurred by the client due to the restriction of the scope of certification and its consequences.
DQS MED is entitled to suspend a certificate for a limited period of time if the customer evidently violates contractual or financial obligations towards DQS MED, especially if:
• corrective actions to the management system have not been evidently and effectively implemented within the agreed timeframe;
• the dates proposed by DQS MED for the assessment necessary for the maintenance of the certification or for the re-certification cannot be complied with and, consequently, the time limit of twelve months is being exceeded;
• DQS MED has not been informed immediately about changes to the management system and other changes which affect the system’s conformity to the underlying standard or specification;
• a DQS MED certificate or a certificate symbol was used in a misleading way;
• the financial obligations agreed to with DQS MED have not been fulfilled;
• the conditions which led to the issuance of the certificate no longer exist;
• the customer does not fulfill his duties of disclosure.
Prior to the decision regarding suspension, the customer will be listened to by DQS MED, unless such a hearing is not possible due to the urgency of the decision to be made.
The suspension of certification is limited in time. If the required measures have been evidently and effectively implemented by the fixed deadline, the certification will be reinstated.
Subsequent to the suspension of a certification, the customer must immediately cease to use the certificate and refrain from such use for the whole period of the suspension. DQS MED is not liable for costs incurred for the customer due to suspension of the certificate or its consequences.
DQS MED is entitled to withdraw certificates if:
• findings which have led to suspension and which have not been concluded within the agreed time frame, but no later than six (6) months after suspension;
• the requirements which led to the granting of the certification are not or no longer fulfilled;
• expiry of the period of suspension (not exceeding six (6) months);
• "imminent danger" with regard to the safety of medical devices;
• an approved medical device no longer meets the essential safety and performance requirements in such a way that patients, users or third parties are exposed to not inconsiderable risks (withdrawal only if the medical device concerned is the only one within the scope of this certificate, otherwise restriction)
• an approved medical device does not fulfill the intended purpose specified by the manufacturer and the defects found are not eliminated within the time frame specified by DQS MED (withdrawal only if the medical device concerned is the only one within the scope of this certificate, otherwise restriction)
• an approved medical device is assigned by the regulatory authorities to another class that is not covered by the issued certificate (withdrawal only if the medical device concerned is the only one within the scope of this certificate, otherwise restriction)
• information from the market (incident reports, complaints, etc.) indicate that the requirements for the scope of certification are systematically and seriously not met;
• an approved medical device is no longer covered by the underlying regulations;
• the contracting entity has unduly influenced the certification procedure in such a way that the impartiality, objectivity, neutrality or independence of the evaluation result is called into question
• a device has been wrongly or erroneously assigned to medical devices according to VO (EU) 2017/745
• the classification of a medical device was wrongly determined and consequently a correspondingly wrong declaration of conformity was issued,
• a manufactured medical device does not comply with the technical documentation that was examined as the basis for contractual obligations of a financial nature are not met;
• contractual obligations of any other kind are not met, in particular
o if the company concerned continues to advertise the certification after the suspension;
o if the affected company uses the certification or the related symbols and documents in an abusive or misleading or otherwise inadmissible way and could thus bring DQS MED into disrepute;
o incidents are not reported to the competent authorities and to DQS MED;
Prior to the decision regarding withdrawal, the client will be consulted by DQS MED, unless such a hearing is not possible due to the urgency of the decision to be made. After the withdrawal of certification, the client has to immediately and irrevocably cease to use the certificate. DQS MED is not liable for costs incurred by the client owing to the withdrawal of the certificate and its consequences.
100_12e_DQS MED_Supplementary Terms of Business_MDR_2020-10.docx