Medical Products (MDD)

In a field that is characterized by fast-moving cycles of innovation, competence and quality are important factors for success. Place your trust in the experts at TÜV Rheinland. We are a notified body authorized to inspect your medical products and in vitro diagnostics and can assist you with the right conformity evaluation procedures for CE marks - meaning you can get your “driving license” for EU countries that little bit quicker. Upon request, we can also certify your quality management system in compliance with the EN ISO 13485, EN ISO 9001, or EN ISO 15378 norms.

With medical product audits and certification from TÜV Rheinland, you can:

• Benefit from our international standing and founded experience when it comes to
  international authorizations
• Avoid faulty developments and minimize the risk of returns with our competent
  development assistance
• Boost confidence in the quality and safety of your products with the TÜV Rheinland brand
• Take advantage of fast audit times and our extensive experience and competence
• Make use of our diverse, one-stop-shop portfolio, as they sa

As a manufacturer of medical products, the CE mark helps document the conformity of your products with the following directives:

• 93/42/EWG for Medical Products (MDD)
• 98/79/EG for in vitro diagnostics (IVD)

Depending on the risk category of the product, you are required to commission a notified body to carry out an EG prototype audit, evaluation of a design dossier, or for auditing the quality management system. Together with you, we carry out the necessary conformity evaluation procedure for your products and company, meaning that you will receive your “driving license” for EU countries that bit quicker. On top of that, we can offer an audit of your medical products for specific or voluntary market requirements.

As a notified body, we carry out the following European homologation processes:

• Conformity evaluation of active and inactive medical products
• Conformity evaluation of active implantable medical devices
• Conformity evaluation of in vitro diagnostics

• EN ISO 9001 certification
• EN ISO 13485 certification for medical product manufacturers
• EN ISO 13485 certification for the preparation of medical products
• EN ISO 15378 certification for primary packing material

• Ergonomics and user compatibility of medical products
• Tested medical products
• Lab products used in healthcare
• Chemical audits, ROHS
• Components

Medical products are separate or combined-use instruments, apparatus, appliances, software, materials, or other objects that are exclusively designed for diagnostic or therapeutic use. This also includes any installed software that ensures the medical device functions flawlessly when used for the following purposes:

• Diagnosis, protecting, monitoring, treatment, or prevention of diseases
• Diagnosis, monitoring, treatment, prevention, or compensation of injuries or handicaps
• Examination, replacement, or change of the anatomic structure or physiological procedure
• Contraception, where the intended effect in or on the human body cannot be attained through simple metabolism, but via the use of pharmacological or immunological substances, and where the efficiency of which can be supported by such substances

An object that is not a product in its own right, but has been specially developed by the manufacturer for specific use in combination with another product.

Medical product regulation states that medical products can be freely handled on the European market as long as they fulfill basic requirements: §7 of the MPG and directive 93/42/EWG, attachment I. The manufacturer confirms conformity of a medical product with basic requirements by labeling every single product with the CE mark. The basic requirements define the target of the presiding medical product directive in that they present a requirement profile for the medical product with which it should comply if it is to be handled freely on the European internal market. The basic requirements specifically cover:

• Safety
• Technical performance
• Medical performance of the product

Technical safety requirements are proven fulfilled with the help of the conformity evaluation procedure, 93/42/EWG directive. It should be demonstrated that technical performance is up to scratch, while medical performance must be proven in terms of clinical evaluation. A product does not necessarily have to fulfill all basic requirements, rather only those appropriate for the product in question and directly related to the purpose of the product. Essentially, the manufacturer is nonetheless obliged to fulfill basic requirements, but the method in which they do this is left up to them.

TÜV Rheinland is registered with the Medical Device Authority (MDA) as a Conformity Assessment Body under the Medical Device Act 2012 (Act 737). All foreign and locally-manufactured Medical Products (MD) at our platform have undergone registration in Malaysia based on the regulations implemented by the MDA.

In addition, TÜV Rheinland is also a notified body under the European Medical Devices Regulation: MDR (EU) 2017/745. This regulation came into force in May 2017 and was implemented to improve the quality, reliability and safety of medical devices. The Medical Devices Regulation (EU) 2017/745 - MDR requires for all medical devices to meet the requirements implemented.

Further to this, TÜV Rheinland is also in the process of obtaining the authorisation for the new In Vitro Diagnostic Regulation: IVDR 2017/746. This regulation came into force in May 2017 with 5 years period transition and will apply from 26 May 2022. The regulation will address several weaknesses of the IVDD. It will also bring significant regulatory changes for IVD manufacturers selling in Europe.

Backed by nearly one and a half centuries of success as a global industry leader, TÜV Rheinland's solid status as a Conformity Assessment Body and Notified Body under local and foreign regulations for medical devices makes it the choice provider for independent testing, inspection and certification services.

Should you have any queries, please feel free to contact us.