Preparation of technical files or its components in line with MDR 2017/745
We have significant experience in the EU Medical Device CE Marking covering key technical areas such as risk analysis, clinical evaluation, validations, usability, in vitro studies (ie. Bioavailability), chemical characteristics. Our adventure with MDD (93/42/EEC) began in 2010 with work with the MDD directive, which allowed us to gain extensive experience that we currently use in working with the requirements described in MDR (2017/745). We specialize in borderline products / medical devices having usually liquid, semi-liquid, solid pharmaceutical forms.
You can directly contact us for medical device technical file preparation.
The purpose of developing technical documentation is to ensure compliance with the essential requirements of the medical device. The conformity assessment procedures included in the annexes to the MDR or IVDR present the scope of technical documentation of the medical device. The scope of technical documentation is dependent on the product class, which determines the path of product conformity assessment. The list of required documents are presented in the Annex II and III to MDR.
Person Responsible for Regulatory Compliance (PRRC)
We are pleased to inform you that we provide the PRRC service for our clients, if you want to learn more, please contact us!
The Medical Devices Regulation (MDR) has set out the figure of the Person Responsible for Regulatory Compliance (PRRC). Each authorised representative has to have their own PRRC, whose role is to ensure that:
- “Minimum mandate” between the manufacturer and the authorised representative fulfils all the requirements of the Regulations (MDR and IVDR), and it is signed by both parties.
- Authorised representative correctly performs the tasks as defined in the Regulations.
- Responsibilities as laid down in the MDR and in the mandate are fulfilled by the AR.
Each authorised representative has to have at least one PRRC, located in the EU. Manufacturers of medical devices must have a PRRC as well. Article 15 of the MDR defines the minimum requirements that a PRRC must have to be designated as such.
For both the EC REP and the manufacturer, the PPRC has to be permanently and continuously at their disposal.
European Authorized representative (EC REP)
Are you planning to introduce your products to the market and are you looking for an authorized European representative with ISO 13485?
As an advisory company, KMJ pharma® Sp. z o.o. offers its clients the possibility of performing the function of Authorised Representative in the European Union.
The Authorised Representative (EAR or EC REP) is a legal unit appointed to represent the producer (based outside the EEA) and act on its behalf in the EU. The “EC REP” is responsible for providing high quality medical devices and their compliance with legal requirements applicable in the Community.
Whether a medical device requires a Notified Body (in the case of Class I sterile/measuring /reusable, IIa, IIb, and III) in order to obtain the CE Marking or the manufacturer is permitted to self-declare (simple Class I), non-EU based manufacturers are legally obligated to appoint an Authorised Representative in order for their products to legally circulate within the EU market.
The Authorised Representative plays a pivotal role in ensuring the compliance of the devices and in serving as contact person established in the Union. The minimum role of the AR encompasses a series of obligations, such as:
- To provide the competent authority with all the information and documentation necessary to demonstrate the conformity of a device.
- To ensure that the technical documentation and other essential documents have been drawn-up, and that the manufacturer has complied with his registration obligations.
- To contact on behalf of the manufacturer with competent authority
- To cooperate with the competent authorities on any preventive or corrective action taken to eliminate or mitigate the risks posed by devices.
- To inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated.
- The EC REP is liable for defective products when the manufacturer has not complied with its obligations under MDR.