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NEWSLETTER
These Regulations, adopted by the Polish Centre for Testing and Certification S.A. (hereinafter referred to as “PCBC”), define the rules for the provision of certification services for medical devices by PCBC in accordance with EU Regulation No. 2017/745 (hereinafter: “MDR”), as a notified body (hereinafter “NB”).
The Manufacturer[1] entrusts PCBC with the relevant certifications to issue the pertinent documents attesting conformity with the MDR (hereinafter, “EU Certificate” or “EU Certificates”).
This Regulation applies to the following EU Certifications:
– EU technical documentation assessment Certificate, according to Annex IX chapter II of the MDR;
– EU quality management system Certificate, according to Annex IX chapter I of the MDR;
– EU quality assurance Certificate, according to Annex XI part A of the MDR;
Each EU Certificate is issued exclusively to the applicant Manufacturer, shall refer to only one conformity assessment procedure and shall detail all individual medical devices covered by EU Certification issued by PCBC.
The EU Certification issued by PCBC is valid for no longer than five (5) years; on the request of the Manufacturer or its Authorized Representative,[2] it can be renewed for further periods of up to five (5) years each, on the basis of a new conformity assessment procedure.
The EU Certificates issued by PCBC are drawn up in Polish and English.
The communications from PCBC to the Manufacturer and vice versa must be drawn up in Polish and/or English.
PCBC’s obligations related to the designation
As an NB, PCBC cannot in any way provide consultancy services regarding the design, manufacturing, marketing or maintenance of the medical devices or processes under assessment.
When carrying out the activity covered by this Regulation, PCBC operates as designated by the Polish Authority responsible for NBs for the MDR.
Therefore, PCBC must operate in accordance with the MDR and its implementing provisions, considering the related guidance documents, which are to be considered expressly referenced by this document.
PCBC must notify the competent Authorities, the Polish Authority responsible for NBs and the European Commission of all information referred to in Art. 56 and 57 of the MDR (e.g. issued, suspended and withdrawn EU Certificates)
Information about PCBC’s notification status is available at the website http://ec.europa.eu/growth/tools- databases/nando/
Suspension, renunciation or revocation of PCBC’s designation
If PCBC’s authorisation to operate is suspended, limited or revoked, it will inform the Manufacturer as soon as possible and within 10 days at the latest. The unduly EU Certificates issued will be suspended or withdrawn by a deadline established by the Polish Authority responsible for NBs.
Preliminary activities before submitting the Application
In order to obtain information on the activities preceding the submission of the application and activities carried out by PCBC as part of the certification, including the applicable fees, the Manufacturer should contact the Application & Verification Specialist, whose contact details are provided on the website www.pcbc.gov.pl in the Services/Product Certification/Medical Devices section.
Application submission
Upon completion of the relevant pre-application activities, the Manufacturer or its Authorized Representative shall submit an application for certification.
The Application must be drawn up and submitted using PCBC’s dedicated Application form, which is available shared by PCBC. It must be filled in fully and signed by a Legal representative (or by an appropriately delegated person) of the Manufacturer or of its Authorised Representative.
Review and acceptance of the Application
PCBC’s acceptance of the Application submitted by the Manufacturer (or its Authorised Representative) depends on a positive outcome of the Application review carried out by the competent PCBC personnel.
The Application review verifies the following aspects:
– that the Application is complete with respect to the requirements of the chosen conformity assessment procedure, including the presence of the full technical documentation;
– that the products covered by the Application qualify as medical devices and their relative classifications; if there is disagreement between the Manufacturer and PCBC about application of the classification rules, PCBC will inform the Manufacturer who should report the question to the competent Authority for resolution, in accordance with Art. 51, section 2, of the MDR;
– that the conformity assessment procedures chosen by the Manufacturer are applicable;
– that PCBC is qualified to assess the Application according to its designation
– that there are sufficient and suitable resources.
The confirmation of the positive review of the application is the preparation of the Contract for Certification and sending it to the Manufacturer for signature.
PCBC does not guarantee, nor can in any way guarantee, a positive outcome of the assessment activity, and subsequently that the relative EU Certificate will be issued.
Conformity Assessment
The Application and related documentation (i.e., technical documentation, quality management system documentation, etc.) must be provided by the Manufacturer in Polish and/or English;
Furthermore, technical documentation and quality management system documentation must be provided with date, signature and in a non-editable format.
PCBC – at its sole discretion – reserves the right to recognise any document such as test reports, Certificates and/or conformity declarations of the Devices and of the quality management systems, etc. issued by other NBs, Certification Bodies, Testing Laboratories or other Bodies.
The purpose of PCBC’s assessment is to verify conformity of the medical device(s), and that of quality management system, to the relevant requirements of the MDR.
Evaluation of the technical documentation
In the process of certification of a medical device, the PCBC performs the formal and substantive documentation assessment submitted by the Manufacturer.
As a result of the assessment of the technical documentation, non-conformities may be identified, which are defined as failure to meet as requirement and are classified as:
Major non-conformity – non-conformity related to MDR requirements and applicable standards and/or affects the ability of the management system to achieve its intended results.
In the case the PCBC finds, during the above-mentioned assessment non-conformities in the assessed documentation, the Manufacturer shall be obliged to complete the documentation or to eliminate non-conformities within the time limit indicated by the PCBC. In the case the Manufacturer fails to complete documentation
or fails to eliminate non-conformities in way acceptable by the PCBC, the PCBC shall send again the request to the Manufacturer to complete the documentation or to resolve non-conformity within period determined by the PCBC.
Failure by the Manufacturer to submit the documentation specified by the PCBC within above-mentioned time limit(s) or to eliminate non-conformities in way acceptable by the PCBC, regardless supplementing the documentation by the Manufacturer within determined time limit(s), shall result in refusal to issue the EU Certificate and termination of the certification process.
Certification Audit
If the technical documentation assessment has a positive outcome, PCBC assigns the certification audit to an audit team made up of one of more parties, guaranteed to be capable of carrying out the required audit activities in the production of a given medical device.
The certification audit must take place at the Manufacturer’s site(s) and at its critical suppliers or subcontractors, if applicable in order to:
– verify that the Manufacturer’s quality management system complies with the requirements of the MDR;
– verify that this system guarantees the medical devices conformity with the relevant requirements of the MDR;
Non-conformities identified during the audit are classified by the audit team and are subject to the following rules:
Major non-conformity – A nonconformity that affects the ability of the management system to achieve its intended results.
– the organization submits to the lead auditor the Action Plan (corrections and corrective actions) within 14 calendar days of receipt of the Non-Conformity Card, and then presents evidence confirming the implementation of corrective actions
– the evidence is assessed before the recommendation and decision on granting / maintaining / renewing the certificate.
Minor non-conformity – a nonconformity that does not affect the ability of the management system to achieve its intended results.
– the organization submits to the lead auditor the Action Plan (corrections and corrective actions) within 14 calendar days from the receipt of the Non-Conformity Card.
– action plans are assessed before the recommendation and decision to issue a certificate, evidence / effectiveness is assessed at the next audit.
Final review and decision-making on certification
Based on the outcome and any other relevant information, PCBC decides whether to issue the EU Certificates of Conformity or not.
If a decision is made to issue an EU Certificate, PCBC issues the EU Certificate to the Manufacturer according to the assessment procedure performed. The decision on certification may impose restrictions (e.g. to the intended use) or request the Manufacturer to start specific post-market clinical follow-up studies (hereinafter “PMCF”).
In case of refusal to issue the EU Certificate,, PCBC informs the Manufacturer of this decision in writing, giving the reasons and the minimum conditions to start the certification process from the beginning.
PCBC reports the issue or rejection of the EU Certification in EUDAMED.
PCBC shall use EUDAMED to report if the Manufacturer withdraws the Application before the final decision.
Special MDR processes
In the case of medical devices containing, as an integral part, a substance which, when used separately, may be considered a medicinal product within the meaning of Art. 1 point 2 of Directive 2001/83/EC, and the operation of which is auxiliary to the operation of this product after the assessment of this substance by PCBC S.A. it is necessary to obtain an opinion of the competent authority for medicinal products in the Member States, such as URPL or EMA, in accordance with Art. 5.2 of Annex IX to Regulation 2017/745.
In the case of medical devices consisting of substances or mixtures of substances which are intended to be introduced into the human body through one of the body orifices or to be applied to the skin and which are absorbed by the human body or locally dispersed in the human body, after the substance has been assessed by PCBC S.A. it is necessary to obtain an opinion of the competent authority for medicinal products in the Member States, such as URPL or EMA, in accordance with Art. 5.4 of Annex IX to Regulation 2017/745.
In the case of products manufactured using animal tissue that are rendered non-viable or non-viable, products derived from animal tissues referred to in Regulation (EU) No 722/2012, PCBC S.A. apply the relevant requirements set out in that regulation.
For class III implantable devices and class IIb active devices intended for the administration and / or removal of a medicinal product, as referred to in section 6.4. of Annex VIII of the Regulation 2017/745, after verification of the clinical assessment of PCBC S.A. submit the applicant’s clinical evaluation dossier and the assessment report to the European Commission for consultation with the Expert Panel, as specified in section 5.1 of Annex IX of Regulation 2017/745.
PCBC activities after issuing the EU certificate.
Audits, including:
Surveillance audits
Surveillance audits at least once every 12 months in accordance with section 3 of Annex IX to the MDR or section 7 of Annex XI to Regulation 2017/745, carried out at the premises of the manufacturer and its suppliers and / or subcontractors, if applicable, on the same basis as a certification audit.
The objective of surveillance audits is assessment of the functioning of the implemented management system in terms of continuous conformity with the requirements set out in MDR .
Unannounced audits
At least once every five (5) years, PCBC performs unannounced audits at each Manufacturer. This frequency may be increased if the medical devices covered by the certification have a potential high risk (e.g. class III medical devices), if there are frequent Non-Conformities or if specific information leads to the belief that they or the related quality management system have Non-Conformities.
Normally, unannounced audits are conducted at the Manufacturer’s premises; in alternative or in addition to these, unannounced audits may be conducted at the premises of subcontractors and critical suppliers, if this can guarantee that the inspection is more effective.
During the unannounced audits, PCBC test an adequate sample of the medical devices produced or an adequate sample from the manufacturing process to verify that the manufactured device is in conformity with the technical documentation. Instead of, or in addition to, PCBC shall take samples of devices from the market to verify that the manufactured device is in conformity with the technical documentation.
The tests may also be performed by the Manufacturer, by a subcontractor or by a critical supplier, under the supervision of PCBC.
Assessing the Periodic Safety Update Report
The Manufacturer must draw up the Periodic Safety Update Report (hereinafter “PSUR”) with the following frequency:
– at least one (1) time per year for class III and IIb Devices and,
– where necessary, and at least every two (2) years for class IIa Devices.
This report is an integral part of the technical documentation and contains:
– a summary of the outcomes and the conclusions of the analyses of the post-market surveillance data gathered;
– the reasons for and a description of any preventive and corrective actions adopted by the Manufacturer;
Each year, the Manufacturer must send to PCBC the PSUR for all class III Devices and implantable Devices for which PCBC has issued an EU Certificate.
PCBC verifies this report, draws up the related assessment report and enters it into EUDAMED.
For devices other than those abovementioned, the Manufacturer must make available the PSUR to PCBC and the competent Authority.
Suspension, restoration and withdrawal of the EU Certificate
PCBC, after prior written notification to the Manufacturer, has the right to suspend or withdraw the EU Certificate in cases specified in the Contract with the Manufacturer.
In the event of suspension of the EU Certificate, the PCBC will set the conditions that must be met for the EU Certificate to be restored. Before the end of the suspension period, a verification will be carried out, which will show whether the conditions for restoration of the EU Certificate have been met. After confirming the fulfillment of the conditions in question, the suspension of the EU Certificate will be revoked and the Manufacturer will be informed in writing about the restoration of the EU Certificate.
PCBC notifies the suspension, restoration or withdrawal of the EU certificate to the EUDAMED database.
Changes in medical devices covered by EU Certificates and approved Quality Management Systems
The scope of changes that are subject to notification to the PCBC for their assessment and approval before implementation are specified in the Contract with the Manufacturer.
Renewal of the EU Certification
The Manufacturer must submit the request on the application form for renewal of the EU Certification validity with PCBC no later than six (8) months before the expiry date of the EU Certificate itself, providing the devices data for which wants to obtain the renewal.
In addition to the documentation requested during the initial certification, the Manufacturer must provide PCBC with a summary of changes and scientific findings of the medical devices, containing at least the following elements:
– all changes to the originally approved Device;
– experience gained from post-market surveillance;
– experience from risk management;
– experience from updating the proof of compliance with the general safety and performance requirements set out in Annex I to MDR;
– experience from reviews of the clinical evaluation, including the results of any clinical investigations and PMCF;
– changes to the requirements, to components of the device or to the scientific or regulatory environment;
– changes to applied or new harmonised standards, CS or equivalent documents;
– changes in medical, scientific and technical knowledge, such as:
[1] Manufacturer means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark
[2] Authorised Representative means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under Regulation 2017/745
PCBC has agreements on recognition of the results of assessment of conformity with Ukrainian partners.
If you are interested in registering medical devices in Ukraine, please contact:
public registry (EDRPOU) code No. 31450352.
tel.: +38(044) 490-27-34,
address: 01042, Ukraine, Kyiv, street Chigorin, 18
e-mail: info@umcs.org.ua
public registry (EDRPOU) code No 37038642
tel.: +38 (044) 227-41-46
address: Ukraine, 04053 Kyiv, Kudryavsky descent 7, office 320
e-mail: office@uni-cert.ua
1/27 M.Pryimachenko St. 01042 Kyiv, Ukraine
Tel/fax +38 044 3555030
e-mail: info@improvemed.com.ua
The Polish Center for Testing and Certification, as the oldest Polish notified body in the field of medical devices, informs that in addition to obtaining the designation in the field of Regulation 2017/745, an application has been submitted to designate Regulation 2017/746 for in vitro diagnostic medical devices.
LIST OF SANDARD FEES FOR WORKS RELATED TO CONFORMITY ASSESSMENT PROCEDURES FOR MEDICAL DEVICES
Declaration of impartiality of the Head of the Medical Devices Certification Department
Declaration of impartiality of the Deputy Head of the Medical Devices Certification Department
Declaration of impartiality of the Deputy Head of the Medical Devices Certification Department
Statements regarding independence and impartiality.
Specjalista ds. Wniosków i Ofertowania/ Application & Verification Specialist
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