Product
certification

Launch your medical device into Europe

CE marking made simple

Certifying medical devices

PolarSeal is registered and audited by the FDA and by a European Notified Body. PolarSeal is accredited to CE mark and manufacture our EctoCare range of products which are classified IIb. which means it can CE mark and manufacture classes up to IIb for our EctoCare range of products.

CE marking medical devices is complex as there are multiple criteria to be considered when accurately classifying it, including:

  • how long the device is intended to be in continuous use
  • whether or not the device is invasive or surgically invasive
  • whether the device is implantable or active
  • whether or not the device contains a substance, which in its own right is considered to be a medicinal substance and has action ancillary to that of the device.
Product certification
Product certification icon
Selecting an appropriate route to conformity assessment

General medical devices: The EU Regulation on Medical Devices 93/42/EEC.

 

In this context, a medical device is defined as any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings.

The preparation of your technical file

After the classification process is complete, we undertake a rigorous series of tests on your device and comparisons to similar products on the market. The complexity of this testing phase increases in-line with the classification of your product.

 

The results of our testing and other procedures are collated and presented to a Notified Body as a technical file, which is used to qualify the device as a ready-to-sell CE marked product.

 

In summary, PolarSeal makes the whole process easier and propels your product to market.

The impact of BREXIT

The ways in which medical devices manufactured for sale in the UK are regulated may well change as a result of the final BREXIT outcome. We are prepared for all eventualities and remain dedicated to providing you a smooth service.

Get in touch to find out more OR BOOK YOUR 1-ON-1 CONSULTATION

CONTACT US

Related Services

CLEANROOM MANUFACTURING

MEDICAL ADHESIVES

MATERIAL SELECTION

QUALITY

PRODUCT DEVELOPMENT AND PROJECT MANAGEMENT

OUTSOURCED OPERATIONS

R&D AND PROTOTYPING

en English
af Afrikaanssq Albanianam Amharicar Arabichy Armenianaz Azerbaijanieu Basquebe Belarusianbn Bengalibs Bosnianbg Bulgarianca Catalanceb Cebuanony Chichewazh-CN Chinese (Simplified)zh-TW Chinese (Traditional)co Corsicanhr Croatiancs Czechda Danishnl Dutchen Englisheo Esperantoet Estoniantl Filipinofi Finnishfr Frenchfy Frisiangl Galicianka Georgiande Germanel Greekgu Gujaratiht Haitian Creoleha Hausahaw Hawaiianiw Hebrewhi Hindihmn Hmonghu Hungarianis Icelandicig Igboid Indonesianga Irishit Italianja Japanesejw Javanesekn Kannadakk Kazakhkm Khmerko Koreanku Kurdish (Kurmanji)ky Kyrgyzlo Laola Latinlv Latvianlt Lithuanianlb Luxembourgishmk Macedonianmg Malagasyms Malayml Malayalammt Maltesemi Maorimr Marathimn Mongolianmy Myanmar (Burmese)ne Nepalino Norwegianps Pashtofa Persianpl Polishpt Portuguesepa Punjabiro Romanianru Russiansm Samoangd Scottish Gaelicsr Serbianst Sesothosn Shonasd Sindhisi Sinhalask Slovaksl Slovenianso Somalies Spanishsu Sudanesesw Swahilisv Swedishtg Tajikta Tamilte Teluguth Thaitr Turkishuk Ukrainianur Urduuz Uzbekvi Vietnamesecy Welshxh Xhosayi Yiddishyo Yorubazu Zulu

Cookies

We use cookies to give you the best possible experience. To get the best results, please make sure you're using the latest version of your browser. By using our website, You're agreeing to our use of cookies on your device. Find out more