Medical device manufacturer website with MDR-compliant content: 2026 cost

The verdict in three sentences

A maker of implantable medical devices cannot show a patient and an orthopaedic surgeon the same information on its website: Regulation (EU) 2017/745 (MDR) and national advertising rules require separating public content from content reserved for healthcare professionals. For a 60 person manufacturer in the Tuttlingen medical technology cluster, a DE/EN/FR site with a verified professional area and electronic instructions for use (eIFU) costs 15,000 to 40,000 EUR excluding VAT on the market. Allow 8 to 12 weeks, a large part of it for regulatory affairs sign-off.

What the MDR changes for a manufacturer's website

Article 7 of the MDR forbids, in labelling, instructions, making available and advertising, any claim that ascribes functions or properties the device does not have or that creates false expectations. The website is therefore a regulated medium, just like a brochure. In Germany, the Heilmittelwerbegesetz (HWG) adds restrictions on advertising medical devices to the general public, which is why technical and surgical content is usually placed behind a professional login.

Implementing Regulation (EU) 2021/2226 governs electronic instructions for use: they are allowed for devices intended exclusively for professional users, provided the manufacturer carries out a risk assessment, states on the label how to access the eIFU, supplies a paper version on request within 7 calendar days, and keeps every previous version available online for the required period.

Recommended architecture: three zones

The public zone presents the company, expertise, quality (ISO 13485, CE certificate from the notified body), careers and validated general patient information. The professional zone, available after registration and verification of healthcare professional status, holds technical sheets, surgical techniques, surgical videos and clinical publications. The eIFU library is accessible without an account by product reference and lot number, because the surgeon or theatre nurse must reach it quickly.

The CMS must handle publication states (draft, marketing reviewed, regulatory approved, published) and keep full history: in an audit, the manufacturer must show which version of a page was live on a given date.

What this kind of site costs in 2026

2026 orders of magnitude from healthcare-specialist agencies and industrial B2B agencies in southern Germany.

Kolonell builds this kind of regulated industrial website on quote, after a workshop with the regulatory affairs lead to map content by access level.

The 8 to 12 week plan

Weeks 1 and 2: scoping workshop, content inventory, classification into public, professional and eIFU. Weeks 3 to 5: design and build of the professional area. Weeks 5 to 8: copywriting, translation and first regulatory review. Weeks 8 to 10: IFU import, versioning tests, acceptance testing. Weeks 10 to 12: final approval, go-live, team training. The bottleneck is almost always regulatory review: reserve 2 to 3 days of the regulatory team's time.

Mini case study

Anja, marketing director of a 60 person orthopaedic implant maker near Tuttlingen, manages 140 paper IFUs in 3 languages. Printing and shipping cost 1.20 EUR per leaflet for 25,000 implants sold a year, or 30,000 EUR a year, and each revision scraps about 4,000 EUR of stock.

She launches a DE/EN/FR site with a professional area and eIFU, priced at 34,000 EUR, plus 600 EUR a month of maintenance, or 7,200 EUR a year. Moving 80% of IFUs to electronic saves 24,000 EUR of printing and about 3,000 EUR of scrapped stock a year, 27,000 EUR in total. Net first-year result: 27,000 − 7,200 − 34,000 = −14,200 EUR, then +19,800 EUR a year afterwards: payback in about 21 months, before counting surgeon enquiries generated by the professional area.

FAQ

Can surgical techniques be published openly?

For implants it is not advisable: this content targets professionals and falls under regulated advertising. A login area with verification within 24 to 48 hours is standard practice.

Can every device move to eIFU?

No, Regulation 2021/2226 covers devices intended for professional users, including implants. A paper copy must still be supplied on request within 7 calendar days.

How many languages do we need?

IFUs follow the language rules of each member state where the device is sold. For the website, DE, EN and FR often cover 70 to 80% of a mid-sized German manufacturer's customers, with the rest handled case by case.

Who approves website content?

A typical workflow has 2 to 3 levels: marketing, regulatory affairs, then possibly medical affairs. The CMS must record each approval with date and author.

Do we need special health data hosting?

Only if the site processes patient health data. A site with a professional area and no patient data does not, which avoids a 30 to 50% hosting premium.

Let's scope your project. We map your public, professional and eIFU content with your regulatory team, then deliver the site in 8 to 12 weeks. Detailed quote within 48 h. WhatsApp +221 77 596 93 33.