Manufacturers must draw up and keep technical documentation that demonstrates that their products conform to the requirements of Annex II and III of the EU MDR. Technical documentation needs to include for ex. Post-market Surveillance (PMS) plan, PMS Report or PMS Safety Report, SSCP.
- Prepare the documentation before drawing up the declaration of conformity;
- Keep the documentation for a period of at least 10 years (15 for implantable devices) after the last products were placed on the market;
- Remember that the Competent Authority can ask to see the technical documentation at any time.
- Preform a technical documentation review to ensure compliance.
- Keep available a copy of the technical documentation readily available for inspection by the Swissmedic.
Every manufacturer should appoint at least one qualified PRRC and a deputy PRRC within its organization to ensure the compliance. The required qualifications to be a PRRC are, amongst others:
- Diploma in in law, medicine, pharmacy, engineering or another relevant scientific discipline and at least 1 year of professional experience in in regulatory affairs or in quality management systems relating to medical devices, or
- 4 years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Detailed qualifications and other modalities are governed by Article 15 EU MDR and Article 49 of MedDO. Be aware that also Swiss Authorised Representative shall appoint a qualified PRRC responsible for regulatory compliance to be continuously and permantely available to the CH-REP.
- We serve as your professional CH-REP with qualified PRRCs continuously available.
When affixing a label to a medical device, certain requirements must be kept in mind:
- Conformity marking (MD logo indicated below or CE marking) shall be affixed on a medical device
- Swiss Authorised Representative and importer shall be present
- UDI carrier on the label is mandatory from:
- 26 May 2021 for implantable devices and class III devices
- 26 May 2023 for class IIa and class IIb devices
- 26 May 2025 for class I devices
- We review your labelling.
- We provide you with general consultancy.
Manufacturers have the legal obligation to monitor the use of their products after they have been placed on the market, in order to promptly react in case of incidents.
Any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, as well as any inadequacy in the information supplied by the manufacturer and any undesirable side-effect;
- Collect as much information as possible (What happened? Is a device involved in the incident? Which device?…)
- Inform your Authorized Representative (CH AR) and provide the gathered information
- Assess together with your CH AR the reportability of the case
- If reportable, it should be communicated to SwissMed.
- We evaluate incidents
- We inform the manufacturer of complaints and incidents
- We report incidents, trend reports and corrective measures
- We communicate swiftly with Swissmedic