FAQ notified body / certification body
FAQ - Certification of medical devices
Certification and conformity assessment
We audit your quality management system according to DIN EN ISO 13485 and perform conformity assessments according to MDR.
Certification of the quality management and quality assurance system is only mandatory for manufacturers who wish to place their products on the market in accordance with Annexes II, V or VI of Directive 93/42/EEC (products of classes Im, Is, IIa, IIb, III). In this case, an audit is typically performed in accordance with DIN EN ISO 13485, which has the presumption of conformity for parts (see Annex ZB of DIN EN ISO 13485) of the directive for these annexes, as well as the supplementary aspects of Directive 93/42/EEC.
For manufacturers of class I medical devices or for healthcare providers (e.g. medical supply stores, orthopaedic technicians, orthopaedic shoe technicians), certification of the quality management system is not required by law, but is indirectly required in some cases via contracts with trading partners or cost bearers. Certification of the quality management system is not required for manufacturers of Class I products or for service providers.
Berlin Cert is designated in the area of Directive 93/42/EEC for medical devices of classes Im, IIa and IIb. We do not offer conformity assessment procedures for class III devices.
For class I products and service providers (orthopedic technology, orthopedic shoe technology, medical supply stores) we offer certifications according to DIN EN ISO 13485. Furthermore, we offer certifications according to DIN EN ISO 13485 for manufacturers of components for medical devices.
In principle, certification is possible for any organization that develops, manufactures, distributes or provides service and installation for medical devices of these classes and falls within the scopes of Berlin Cert for the certification of QM or QA systems.
The certification process is described in detail in the certification regulations of Berlin Cert. In summary, it consists of the following phases:
- Submitting the information necessary for planning the certification process, e.g. by completing the System Certification Questionnaire.
- Preparation and confirmation of an offer
- Submission of an application in preparation for the certification procedure
- Confirmation of the application and presentation of the audit team
- Joint audit planning and coordination
- Preliminary evaluation of the QM documentation
- Certification audit in the company
- Preparation of a detailed audit report
- Implementation of corrective measures, if necessary
- Issue of certificate and contractual agreement on the use of the mark
- Surveillance audits
- Recertification audit
If you have any questions about the process, just contact the office team.
- Business management effects (reduction of rejects and rework, reduction of costs for warranty and follow-up services, elimination of incoming goods inspections)
- Process organization (increase of company presence, avoidance of faulty actions, employee motivation)
- Marketing (advertising impact, differentiation from competitors without certificate, ensuring product quality)
- Liability (proof of liability possible, avoidance of unjustified or criminal claims if necessary)
- Customer-oriented work and collegial atmosphere
- Short lines of communication and direct response to your inquiries
- Competent and friendly team in a small certification body
- Many years of experience in QM certification in the medical environment
- Reasonable price-performance ratio
- Wide range of certification services through close cooperation with GUTcert
- The integration of Berlin Cert into the Afnor Group provides additional security.
Scopes der Berlin Cert
Berlin Cert GmbH offers certifications according to EU Regulation 2017/745 (MDR) for Annexes IX, X, XI(A), XI(B) for medical devices of classes Ir, Im, IIa, IIb and III in the following scopes:
- MDA 0202: Active non-implantable devices for imaging procedures with non-ionizing radiation
- MDA 0203: Active non-implantable devices for monitoring vital physiological parameters
- MDA 0204: Other active non-implantable devices for monitoring and/or diagnosis
- MDA 0302: Active non-implantable products with non-ionizing radiation
- MDA 0305: Active non-implantable products for stimulation or inhibition
- MDA 0306: Active non-implantable devices for extracorporeal circuits, for the administration or removal of substances and for hemopheresis (Restriction: Excluding active devices intended to deliver and/or remove drugs, body fluids or other substances to and/or from the body, when this procedure poses a potential hazard, taking into account the nature of the substances concerned, the part of the body concerned and the mode of application (Rule 12 Annex VIII Regulation (EU) 2017/745))
- MDA 0307: Active non-implantable respiratory devices.
- MDA 0309: Active non-implantable ophthalmic devices
- MDA 0310: Active non-implantable ear, nose and throat devices
- MDA 0311: Active non-implantable dental products
- MDA 0312: Other active non-implantable surgical products
- MDA 0313: Active non-implantable prostheses, rehabilitation products and patient positioning and transport products
- MDA 0315: Software
- MDA 0316: Medical gas supply equipment and parts thereof
- MDA 0317: Active non-implantable products for cleaning, disinfection and sterilization (restriction: only cleaning and disinfection)
- MDA 0318: Other active non-implantable products
- MDN 1205: non-active non-implantable devices for orthopedics and rehabilitation
- MDN 1207: non-active non-implantable diagnostic devices
- MDN 1208: non-active non-implantable instruments
- MDN 1214: general non-active non-implantable products and other non-active non-implantable products used in the health sector
- MD 1301: devices for monitoring non-vital physiological parameters
- MD 1302: devices for monitoring vital physiological parameters
- Repair, maintenance and installation of medical devices (in scopes as above).
- Manufacturer of custom-made products in the fields of orthopedic and orthopedic shoe technology, rehabilitation technology and medical supply stores
- Trade of medical devices
- Transport of medical devices
- Preparation of technical documentation for active medical devices, non-active orthopedic devices and non-active instruments (this includes the preparation of clinical evaluations)