CE Marking

Medical Device Regulation (MDR)

Medical devices face a wide range of market-specific regulatory requirements as well as numerous client-defined quality standards. All of which cost time, money and absorb valuable resources LUX-IEC cost effectively ensures manufacturers or importers overcome any and all these hurdles putting your products in the hands of medical professionals Fast! Make LUX-IEC your global compliance solutions partner for all your medical devices!

LAUNCH YOUR PRODUCT FASTER ... LET US SHOW YOU THE WAY!

We draw upon extensive regulatory knowledge of multiple jurisdictions employing a highly flexible approach in establishing suitable assessment procedures.  Through our combination of audits we ensure your device is simultaneously compliant with the requirements of multiple certifications

Independent Testing
  • EU /International product safety, including IEC/EN 60601, IEC/EN 61010 series and the CB scheme for 52+ countries

  • US NRTL (UL standards) and standards council of Canada

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  • EMC testing (IEC/EN 606011-2 and CE Marking)

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  • Approval for overlapping EC directives: Machinery, PPE, Pressure Equipment, Non-Automatic Weighing Equipment

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  • Wireless testing/telemedicine

  • Restricted substance testing, including testing to RoHS 2 requirements for medical devices

Certification

Regulatory, quality audit and certification services:

 

  • ISO 13485:2003

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  • ISO 9001:2008 (for medical devices)

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  • 93/42/EEC amended by 2007/47/ EC and 98/79/EC (Medical Device Directive -CE marking for Europe)

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  • 510(k) support services for test data, advisory and factory followup

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  • Other EC directives (CE marking of PPE, pressure vessels, NAWI, and more)

Other certifications:

  • CMDCAS (Canada),

  • JPAL (Japan),

  • INMETRO (Brazil),

  • Taiwan, Australia and Hong Kong 

Training & Consultancy
  • QMS/auditing (ISO 13485:2003; internal auditing), Global regulations (CE marking, FDA, JPAL), sterilisation (radiation, ethylene oxide, steam), risk management (ISO 14971:2007)

 

  • Product safety and EMC (IEC 60601 series)

 

  • Biocompatibility and biological evaluation of medical devices (ISO 10993)

 

  • Audits –supplier audits, gap analysis, pharmaceutical /cosmetic GMP

 

  • Clinical trials

 

  • Hygienic qualification of production facilities

 

  • Microbiological and Toxic residue product tests pre/post sterilisation

The New EU Medical Device Regulation - Article 44

Article 44 is designed to combat the widespread fraud and inconsistent interpretation of the above Directives. Notified Bodies will be subject to unannounced audits.

 

This increased workload will inevitably result in greater expense for manufacturers.  Furthermore, due to aggressive recruitment activities by Notified Bodies, very few manufacturers can rely on the stability of having a known ‘auditor’ each year.

 

In-Vitro Diagnostics manufacturers are most impacted by changes to the EMDR. Currently, only 20% of IVD devices necessitate Notified Body involvement. Likely to increase to 80%.

 

The EMDR further requires MD regulated devices to be reclassified as Class III requiring a design examination certificate. These product-specific CE certificates require a review of all design alterations.

 

 

EMDR also address reporting issues such as compulsory updating of technical files, declarations of conformity and labeling. A new highly prescriptive format – including UDI - requires manufacturers to create a summary document for each section instead of an overall report.

 

 

Lastly, manufacturers will need to define precisely any residual risks associated with their device; to be included as warnings and precautions in the instructions for use.  This then must be submitted to Eudamed. 

Key Changes

Clarification of current requirements

  • Example: Invasive devices intended for connection to a class 1 active medical device are now included in the classification.

 

PPE / Machinery Directives / EMC Compliance (4th Edition)

  • Example: Mutual exclusion between MDD & Personal Protective Equipment Directive (PPE) is removed. Medical devices under Machinery Directive must cover both directive requirements.

 

Essential Requirements & Labelling

 

  • Example 1: Product design to consider technical knowledge, experience, education and training of the user etc.

  • Example 2: Demonstration of conformity to include clinical evaluation.

 

Technical Documentation & NB Assessment

  • Example1: The technical file now includes intended use of the device, sterilization reports and clinical evaluation.

  • Example 2: Class 1 devices to be included in ANNEX II certificates.

 

Declaration of Conformity

 

  • Example 1: To clearly identify the products it relates to.

 

European Representative

  • Example 2: Manufacturers shall designate a single authorized representative per device.

Impact on Manufacturers
  • Be subject to impromptu audits by Notified Bodies.

 

  • Have to reclassify spinal implants and any device that control /monitor active implants, nanomaterials, apheresis machines and combination products as Class III.

 

  • Require Notified Body involvement for most in vitro diagnostics (IVDs).

 

  • Need to add a Unique Device Identification (UDI) to all labelling to support the expanded European Databank on Medical Devices.

 

  • Revise the formatting of the declarations of conformity and technical files.

 

  • Submit recommendations for CE Marking to The European Commission for review prior to approval.

 

  • Work with the newly created Special Notified Bodies to issue CE Certificates for any high-risk devices such as implants.

 

  • Need to ensure that their Notified Bodies has been audited for compliance with the new regulations by the regulatory body for each member state.