The CE labelling of a medical device is not a one-off act, but an ongoing process. Manufacturers and their Person Responsible for Regulatroy Compliance (PRRC) must ensure that their products are not only compliant when they enter the market, but also adapt to the dynamic regulatory requirements in the long term. The basis for this obligation is formed by regulations such as Regulation (EU) 2017/745 - Medical Device Regulation (MDR) - as well as other national and international standards.
What Needs to be Maintained?
The maintenance of CE documentation concerns two areas of documentation in particular:
- CE documentation: This includes technical documentation (TD) as well as verification and validation documents, which must be kept up to date at all times.
- Quality management documentation (QM documentation): The QM system must be continuously maintained and implemented.
Sources of New Regulatory Requirements
Regulatory changes and amended requirements Arise from various sources:
- MDR and other legal requirements: In addition to the MDR national legislators publish amendments that may have an impact on medical devices.
- Updates to the German Medical Technical Aids Register (HMV): For products that are to be reimbursable in the German healthcare market, updates to the National Association of Statutory Health Insurance Funds (GKV-SV) essential.
- Standardisation institutes and commissions: New or updated standards from DIN, EN, IEC or ISO may impose new requirements for safety and performance testing.
What parameters must be taken into account?
Ongoing compliance requires targeted monitoring of the following aspects:
- Regulatory requirements: Manufacturers must adapt their technical documentation and QM systems to new regulatory frameworks (e.g. change from MDD to MDR).
- Normative requirements: Standards such as EN ISO 13485 (specification of requirements for comprehensive QM systems) or specific technical standards are constantly evolving and influencing the requirements for medical devices.
- Research findings and new scientific knowledge: Updated clinical evaluations or new safety requirements may necessitate adjustments.
- GKV-SV Announcements: Updating the HMV may change specific product requirements or requirements for the instructions for use.
How is Conformity Assessed?
Compliance with the regulations can be verified by various authorities:
- External audits by notified bodies or certification organisations
- Official inspections by national market surveillance authorities
- Internal audits conducted by independent experts such as BEO BERLIN
Conclusion: Why BEO BERLIN is the right partner for you
Monitoring all relevant regulatory developments is complex and time-consuming. This can be particularly challenging for small and medium-sized buisnesses (SMBs).
BEO BERLIN offers:
- Proactive monitoring of relevant regulatory changes and standards.
- Support with the continuous updating of technical documentation and QM documentation.
- Internal auditing to ensure CE conformity.
- Advice and representation in dealings with notified bodies and authorities.
Contact us and secure the long-term marketability of your medical devices!
(2 Rating(s), average: 5.00 out of 5)
Loading...
