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The appointment is made by letter of appointment from the company. This letter must be signed by a person sufficiently authorised to represent the company, preferably by the company’s managing directors. The letter of appointment must be countersigned by the PRRC. A template “Letter of Appointment” is available.
Yes. A manufacturer must have available at least one PRRC within its organisation. This means that an internal PRRC needs to be appointed. This also applies to manufacturers of custom-made devices. Exceptions are made for micro and small enterprises. They may appoint an external service provider to act as their PRRC. The authorized representative may also appoint an external PRRC.
Yes, this is permitted. The fact that the PRRC himself or herself must belong to the manufacturer’s organisation does not mean that he or she cannot use the services of external service providers in the performance of his or her duties. The PRRC must additionally have the necessary powers to give instructions to employees of the enterprise for the purposes of implementing the required measures in the performance of his or her duties.
Yes. The PRRC must be registered in the electronic EUDAMED database. Even though the EU Commission has now given notice that the setting up of EUDAMED with all its new functions will probably not be completed before May 2022, the appointment of the PRRC must be carried out in due time, by 26 May 2020.
What documents can be used as evidence of professional experience in regulatory affairs or in quality management?
The following supporting documents can be used for this purpose:
Employment contract evidencing that the person works in the area of regulatory affairs or in quality management and also since when he or she has done so.
Organisation chart evidencing the function
Evidence of training completed on topics such as quality management, medical device law, market surveillance, risk management, reporting
Records such as audit reports and approval of documents
If the company concerned is a German company and the person has already acted as a safety officer under Section 30 German Medical Devices Act (MPG), thus performing some of the tasks of a PRRC, the registration of this person with the German Institute of Medical Documentation and Information (DIMDI) as a safety officer can also be used as evidence of the relevant professional experience.
If other Member States have hitherto had in place statutory provisions in accordance with national medical device law which required a responsible person who performed some of the tasks of a PRRC, proof of this function can also be used as evidence of the relevant professional experience.
Yes, the PRRC has comprehensive documentation obligations. Where possible, templates will be made available to keep the administrative effort to a minimum and support the PRRCs in the performance of their duties.
Yes, according to the Medical Device Regulation, a number of persons may be jointly responsible for regulatory compliance. In this case, their respective areas of responsibility must be stipulated in writing.
However, this option will not be made use of during the introductory phase. If necessary, we will decide at a later date whether more than one person should be appointed in light of the comprehensive duties and responsibilities.
There is a prohibition on disadvantages for the PRRC. The PRRC shall suffer no disadvantage within the manufacturer’s organisation in relation to the proper fulfilment of his or her duties. It is unclear to date how the Member States will transpose this prohibition into national law. It is also unclear how the national labour courts will deal with this prohibition (possibly right to obtain a cease and desist order under employment law or separate protection against dismissal).
We have one additional site who is a distributor only, and where no manufacturing takes place. Which would be the appropriate letter template for this one?
A distributor is only obliged to appoint a PRRC if he assumes the obligations incumbent on manufacturers. This is the case if the distributor does any of the following:
a) makes available on the market a device under its name, registered trade name or registered trade mark. However, the distributor may also enter into an agreement with the manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in the Medical Device Regulation (MDR). In this case the distributor is not required to appoint a PRRC.
(b) changes the intended purpose of a device already placed on the market or put into service;
(c) modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.
However, the above-mentioned provision does not apply if the distributor assembles or adapts for an individual patient a device already on the market without changing its intended purpose. Nor shall the provision of information (labelling and package leaflet), including its translation, or any other information necessary for marketing in the Member State concerned be regarded as a change affecting conformity. It should therefore first be carefully examined whether the conditions under a) – c) are fulfilled and the appointment of a PRRC is required.
If a PRRC has to be appointed the letterhead “Manufacturer” will be the appropriate template.
Micro and small manufacturers are not required to appoint a PRRC within their organization but shall have such a person permanently and continuously at their disposal. Therefore, the appointment of an external PRRC is an option. ?An agreement must be concluded with the external service provider. This agreement should stipulate that the person assuming the task of the PRRC has the qualifications required by the Medical Device Regulation (MDR). It must also me agreed that the manufacturer will have this person permanently and continuously at their disposal. ?
In addition, the person that assumes the role of PRRC should sign the letterhead to confirm that he/she accepts the office and duties and he/she has the qualifications required. Annexes 1 and 2 must also be completed. Deviating from the template the letterhead should indicate that the PRRC is an external PRRC: “ We herewith appoint [title, first and last name], [function], employee of [external service provider] as External Person responsible for regulatory compliance (PRRC) according to Article 15 REGULATION (EU) 2017/745 …”.?This provides a document that can be presented to the authorities if required.
Yes, under certain conditions. According to article 15(1) every manufacturer (including manufacturers of custom-made devices) shall have available at least one PRRC within their organisation. Only micro and small businesses (>50 employees, >10 Mio. € Revenue) are allowed to not have such a person within their organisation, as long as they have one permanently at their disposal.
As manufacturer of custom-made devices, can we refer to the doctor‘s prescription for the clinical evaluation as we can assume the prescription is based on a clinical evaluation of the medical device?
The medical prescription is not sufficient to deliver adequate clinical evidence according to article 61 and cannot substitute a clinical evaluation.
“Confirmation of conformity with relevant general safety and performance requirements set out in Annex I under the normal conditions of the intended use of the device, and the evaluation of the undesirable side-effects and of the acceptability of the benefit-risk- ratio referred to in Sections 1 and 8 of Annex I, shall be based on clinical data providing sufficient clinical evidence, including where applicable relevant data as referred to in Annex III.“[EU-MDR Article 61 (1)]
Do we consider the clinical evaluation of CE-marked parts in a patient solutation as evidence in regards to clinical evaluation for the entire patient solution, if the entire patient solution only consists of CE-marked products?
Yes, no additional clinical evaluation is required in that case. But usually a patient solutions contains at least one custom-made part, e.g. a socket. In that case the custom-made device requires a clinical evaluation as well. This can be covered by a clinical evaluation for the complete treatment solution.
If we have to clinically evaluate our custom-made devices: Is one clinical evaluation per product group Prosthetics upper Extremities, Prosthetics lower Extremities, Orthotics upper Extremities, etc. sufficient? Or is it better to classify products based on intended use, materials and way of production similar to our risk analyses?
For products, which are not custom made devices, an individual clinical evaluation is required. Both approaches – either to cover clinical evaluation on product group level or on similar materials/intended uses/etc – work from regulatory point of view.
Is post-market clinical follow-up (PMCF) required for custom-made devices, even though they do not carry a CE-mark or is post-market surveillance sufficient?
Even though the custom-made devices do not carry the CE-mark, PMCF as well as PMS has to be conducted (according to part B of Annex XIII and Annex XIV of the EU-MDR).
It is possible to use follow-up appointments to gather PMS data. Focus should be placed on damaged or worn out components. If necessary they should be tracked as a complaint to be included in the PMS report later on.
This is not defined in the MDR. Please refer to the national regulations in the respective countries.
Yes, the MDR requires a prescription, so that the device can be categorised as a custom-made device. Please note that based on national provisions even CPO may be allowed to issue such prescription.
Why is it important to combine only components that are meant to be combined? How do I know if I am allowed to combine certain components?
The MDR requires manufacturers to evaluate the safe and effective combination of devices. Therefore if combinations are made by the CPO this is performed under his responsibility and liability is transferred onto him. Allowed (and not allowed) combinations are usually provided in the respective instructions for use.
Not all components produced by the same manufacturer are intended to be combined together. Some combinations may be restricted. Always refer to the instructions for use provided with the components.
In this case the CPO assumes full responsibility regarding safety and effectiveness of the provided patient solution and all the regulatory requirements of a manufacturer apply. The CPO has to do the following steps, among others:
Perform a conformity assessment of the patient solution according to the specific intended use.
Establish evidence documentation to claim conformance, such as:
- Risk management file (needs to be adapted)
- Additional testing
- Justifications or rationales
Yes, according to article 83 (1) and (3g):“… for each device the manufacturer shall plan, establish and document a post market system, which amongst other shall be used to detect and reports trends…“
Yes, paperwork is still ok as long as all required contents is available. The MDR does not mention any format.
Is there still a necessity for medical device advisors as defined in the Medical Device Ordenance (MPG = Medizinproduktegesetz)?
Yes. The requirements in regard to medical device advisors, as defined in §31 of the MPG, will still exist. Nonetheless the legal framework in Germany has changed. The new medical device advisor is defined in §83 of the „Medizinproduktedurchführungsgesetz“. The requirements are mostly identical though.
Is the medical device file according to ISO 13485 identical to the Technical Documentation of the MDR?
Yes, they can be considered identical as long as the European Market is covered as well.
Please note that the ISO 13485:2016 is an international standard. It demands to cover all applicable regulatory requirements for a medical device, which includes European requirements (e.g. MDR) as well.