EU Regulations for Medical Devices & Single Audit Program: What’s Changing?
With over 500,000 types of medical devices and in-vitro diagnostic medical devices on the EU market, sturdy regulation that ensures a safe supply is essential.
Back in May 2017, the EU released two new regulations:
- Regulation (EU) 2017/745 on medical devices (MDR)
- Regulation (EU) 2017/746 on in-vitro diagnostic medical devices (IVDR)
These will replace the existing Medical Device Directives:
- Directive on active implantable medical devices: 90/385/EEC (AIMD)
- Directive concerning medical devices: 93/42/EEC (MDD)
- Directive on in-vitro diagnostic medical devices: 98/79/EEC (IVDD)
- Stricter control for high-risk devices via a new pre-market scrutiny mechanism
- Increased criterion for the designation of medical Notified Bodies
- Inclusion of certain aesthetic devices which present the same characteristics and risk profile as medical devices (e.g. non-corrective tinted contact lenses)
- Introduction of a new risk classification system for in-vitro diagnostic medical devices in line with international guidance
- An improved device traceability system based on Unique Device Identification (UDI)
- Introduction of an “implant card” for patients with implanted medical devices
- Reinforcement of the rules on clinical evidence
- EU-wide coordinated procedure for authorisation of multi-centre clinical investigations
- A strengthening of post-market surveillance requirements for manufacturers
- Improved coordination for vigilance and market surveillance between EU member states
The new regulations will apply after differing transitional periods: 3 years for the MDR (26th May 2020) and 5 years for the IVDR (26th May 2022).
Therefore, all medical manufacturers need to be aware of the changes that these new regulations will bring to their devices.
In essence, the new regulations provide a more robust legislative framework with the intention of providing a stronger level of public health protection and patient safety. Many of the EU’s medical guidance documents (MED DEVs) have been incorporated as mandatory requirements under the MDR and IVDR.
Key changes include:
Medical device manufacturers who are selling outside the EU will also need to be aware of the Medical Device Single Audit Program (MDSAP). This program, developed by the International Medical Device Regulatory Forum (IMDRF), allows manufacturers to be audited once by an MDSAP-recognised Auditing Organisation. The MDSAP audit can be conducted alongside the manufacturers’ regular ISO 13485 QMS audit for CE marking.
There are currently 5 countries currently signed up to MDSAP:
All share the core of the MDSAP requirements, but each country does have specific requirements within different areas. These are all well-explained in an extremely useful MDSAP companion document.
Both the new EU regulations and the MDSAP will be putting additional burdens on the operations and quality management systems of medical devices manufacturers.
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