Is your work already compliant?

At some point you will reach the moment where you say:

"We have revised all necessary existing processes or even introduced new processes and are now well established."

In order to remove the last uncertainties you may still have, we provide you with a compliance checklist that you can use to check whether you have really thought of everything. It is easy for something, even a small detail, to be forgotten. And that would be very unfortunate, considering the work you and your team have put into implementing this project.

Compliance check

Select your role to find out the respective requirements.


MDR article

MDR requirement

Comment
Article 14 (1)When making a device available on the market, distributors shall, in the context of their activities, act with due diligence in relation to the applicable requirements.Compliant if all requirements of article 14 are fulfilled.
Article 14 (2)Before making a device available on the market, distributors shall verify that all of the following requirements are met:
(a) The device has been CE marked and the EU declaration of conformity of the device has been drawn up;
(b) The device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);
(c) for imported devices, the importer has complied with the requirements set out in Article 13(3);
(d) Where applicable, a UDI has been assigned by the manufacturer.
Compliant if either the factors are checked directly or there is a contract with the manufacturer of purchased devices that outlines the competences of each side.
Article 14 (2)
In order to meet the requirements referred to in points (a), (b) and (d) of the first subparagraph, the distributor may apply a sampling method that is representative of the devices supplied by that distributor.If devices are checked, the use of a known and scientific sampling method for compliance is allowed.
Article 14 (2)Where a distributor considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not make the device available on the market until it has been brought into conformity, and shall inform the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. Where the distributor considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the member state in which it is established.If you are aware that you are not allowed to sell unchecked devices, this is compliant.
Article 14 (3)Distributors shall ensure that, while the device is under their responsibility, storage or transport conditions comply with the conditions set by the manufacturer.Compliant if either the factors are checked directly or there is a contract with the manufacturer of purchased devices that outlines the competences of each side.
Article 14 (4)Distributors that consider or have reason to believe that a device which they have made available on the market is not in conformity with this Regulation shall immediately inform the manufacturer and, where applicable, the manufacturer's authorised representative and the importer. Distributors shall co-operate with the manufacturer and, where applicable, the manufacturer's authorised representative and the importer and with competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or to recall it, as appropriate, is taken. Where the distributor considers or has reason to believe that the device presents a serious risk, it shall also immediately inform the competent authorities of the member states in which it made the device available, giving details, in particular, of the non-compliance and of any corrective action taken.Be able to get in contact with manufacturers about complaints and non-conformities.

If the used vigilance process is applied, this shall be covered.
Article 14 (5)Distributors that have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device they have made available shall immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative and the importer. They shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request.Be able to get in contact with manufacturers about complaints and non-conformities.

If the used vigilance process is applied, this shall be covered.
Article 14 (6)Distributors shall, upon request by a competent authority, provide it with all the information and documentation that is at their disposal and is necessary to demonstrate the conformity of a device.You need to work with your competent authority and provide necessary documents on request.

This is assumed to be generally compliant and is not different from the current situation under the MDD.
Article 14 (6)Distributors shall be considered to have fulfilled the obligation referred to in the first subparagraph when the manufacturer or, where applicable, the authorised representative for the device in question provides the required information. Distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market. Distributors, upon request by a competent authority, shall provide free samples of the device or, where that is impracticable, grant access to the device.You need to work with your competent authority and provide necessary documents on request.

This is assumed to be generally compliant and is not different from the current situation under the MDD.

MDR article

MDR requirement

Comment
Article 10 (1)When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation.If all processes and documents mentioned in the requirements below are available and used, this shall be compliant.
Article 10 (2)Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I.Have a risk management process and documents for all custom-made devices and patient solutions.

Using the supplied process can ensure compliance.
Article 10 (3)Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF.Have a clinical evaluation process and documents for all custom-made devices and patient solutions.

Using the supplied process can ensure compliance.
Article 10 (16)Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law. Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.Insurance for damage compensation must be in place to achieve compliance.
Article 15 (1)Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:
(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the member state concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.
If a person responsible for regulatory compliance has been appointed, this requirement is fulfilled.

MDR article

MDR requirement

Comment
Article 10 (1)When placing their devices on the market or putting them into service, manufacturers shall ensure that they have been designed and manufactured in accordance with the requirements of this Regulation.If all processes and documents mentioned in the requirements below are available and used, this shall be compliant.
Article 10 (2)Manufacturers shall establish, document, implement and maintain a system for risk management as described in Section 3 of Annex I.Have a risk management process and documents for all custom-made devices and patient solutions.

Using the supplied process can ensure compliance.
Article 10 (3)Manufacturers shall conduct a clinical evaluation in accordance with the requirements set out in Article 61 and Annex XIV, including a PMCF.Have a clinical evaluation process and documents for all custom-made devices and patient solutions.

Using the supplied process can ensure compliance.
Article 10 (16)Natural or legal persons may claim compensation for damage caused by a defective device in accordance with applicable Union and national law. Manufacturers shall, in a manner that is proportionate to the risk class, type of device and the size of the enterprise, have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.Insurance for damage compensation must be in place to achieve compliance.
Article 15 (1)Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:
(a) a diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the member state concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
(b) four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.
If a person responsible for regulatory compliance has been appointed, this requirement is fulfilled.
Annex XIII (1)For custom-made devices, the manufacturer or its authorised representative shall draw up a statement containing all of the following information:If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled.
Annex XIII (1)'— the name and address of the manufacturer and of all manufacturing sites,If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled.
Annex XIII (1)'— if applicable, the name and address of the authorised representative,If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled.
Annex XIII (1)'— data allowing identification of the device in question,If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled.
Annex XIII (1)'— a statement that the device is intended for exclusive use by a particular patient or user, identified by name, an acronym or a numerical code,If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled.
Annex XIII (1)'— the name of the person who made out the prescription and who is authorised by national law by virtue of their professional qualifications to do so, and, where applicable, the name of the health institution concerned,If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled.
Annex XIII (1)'— the specific characteristics of the product as indicated by the prescription,If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled.
Annex XIII (1)'— a statement that the device in question conforms to the general safety and performance requirements set out in Annex I and, where applicable, indicating which general safety and performance requirements have not been fully met, together with the grounds,If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled.
Annex XIII (1)'— where applicable, an indication that the device contains or incorporates a medicinal substance, including a human blood or plasma derivative, or tissues or cells of human origin or of animal origin as referred to in Regulation (EU) No 722/2012.If the patient solution statement (template provided by Ottobock) is used, this requirement is fulfilled.
This is most likely applicable only for materials of animal origin (e.g. leather)
Annex XIII (2)The manufacturer shall undertake to keep available for the competent national authorities documentation that indicates its manufacturing site or sites and allows an understanding to be formed of the design, manufacture and performance of the device, including the expected performance, so as to allow assessment of conformity with the requirements of this Regulation.Control and document your manufacturing processes
Annex XIII (3)The manufacturer shall take all the measures necessary to ensure that the manufacturing process produces devices that are manufactured in accordance with the documentation referred to in Section 2.Control and document your manufacturing processes. As a minimum, the manufacturing specification should be checked, e.g. record fitting or measurements of geometrical specifications delivered by the PCC.
Annex XIII (4)The statement referred to in the introductory part of Section 1 shall be kept for a period of at least 10 years after the device has been placed on the market. In the case of implantable devices, the period shall be at least 15 years.
Section 8 of Annex IX shall apply.
Compliant if the documentation is planned to be stored for at least 10 years.
Annex XIII (5)The manufacturer shall review and document experience gained in the post-production phase, including from PMCF as referred to in Part B of Annex XIV, and implement appropriate means to apply any necessary corrective action. In that context, it shall report in accordance with Article 87(1) to the competent authorities any serious incidents or field safety corrective actions or both as soon as it learns of them.Have a post-market surveillance (PMS) process and documents for all manufactured custom-made devices and patient solutions.

Using the supplied process will make this requirement compliant.

Download your compliance checklist here!

Here you find three lists that can be used for self assessment. Please note that if you are acting in the role of different economic operators, several checklists are relevant for you.