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Lagom Consulting
EN

Regulatory consulting for eyewear since 2012

EU compliance for eyewear in sharp focus

We are eyewear specialists with more than 20 years of combined experience. We help companies comply with Regulation (EU) 2017/745 for frames, lenses and ready-made readers and with Regulation (EU) 2016/425 for sunglasses.

We are ready to make your life simpler

Complying with the regulations can seem very complex. Our mission is to simplify that complexity by guiding you through every stage.

Find out how

To sell in the EU you need an EC REP established in the Union. We can be yours

Every non-EU manufacturer of medical devices must appoint an Authorised Representative (EC REP) under a written mandate, and its name goes on the label. Sunglasses also need an economic operator in the EU. We cover both.

What you need, point by point

The prescription for compliance

Three questions and you know what you need

We give you an eye test, just like at the optician, with 3 questions: first we take the measurements and then we give you the prescription.
Answer to find out what you need and who takes care of it.

1Where is your company based?

2What do you want to sell in Europe? Choose as many as apply.
3Where are you now?

Compliance prescription

Based
to be chosen
Products
to be chosen
Regulations
Reg. (EU) 2017/745 · MDR · Reg. (EU) 2016/425 · PPE

Free documentation check-up

Send us what you have: we review it for free, with no commitment, and tell you what to fix and in what order.

What you need

Answer the questions to see your prescription

  1. EU Authorised Representative (EC REP)

    MDR Art. 11

    Lagom takes care of it

  2. An economic operator in the EU

    Reg. (EU) 2019/1020 Art. 4; Reg. (EU) 2016/425 Art. 9

    Lagom takes care of it

  3. An importer who is ready

    MDR Art. 13; Reg. (EU) 2016/425 Art. 10

    Lagom takes care of it

  4. Person Responsible for Regulatory Compliance (PRRC)

    MDR Art. 15

    Lagom takes care of it

  5. Technical documentation

    MDR Annexes II and III

    Lagom takes care of it

  6. EU declaration of conformity and CE marking

    MDR Arts. 19 and 20, Annex IV

    Lagom takes care of it

  7. UDI and EUDAMED

    MDR Arts. 27, 29 and 31

    Lagom takes care of it

  8. Post-market surveillance

    MDR Arts. 83-85, Annex XIV

    Lagom takes care of it

  9. Testing to EN ISO 12312-1

    Reg. (EU) 2016/425 Annex I

    Lagom takes care of it

  10. Technical documentation, EU declaration and CE

    Reg. (EU) 2016/425 Annexes III, IV and IX

    Lagom takes care of it

  11. Documentation audit

    MDR Art. 93

    Lagom takes care of it

Leave it to usBook the free check-up

For guidance only: every product is assessed case by case.

What they say

Professional advice, zero worries. Here is what our clients say about us

companies supported
60+
countries of origin
8
in eyewear since
2012

Thanks to their consultancy in MDR and EUDAMED, we have been able to obtain the key requirements necessary to consolidate and expand our brand into new markets, allowing us to take a significant step forward in our development and global positioning.

Folc Eyewear · Marta Linarès

Their in-depth expertise in the eyewear industry allows them to address our specific needs and guide us through every stage of the project with competence. Their professional and solution-oriented approach makes them a valuable partner whom we would highly recommend.

Götti · Thomas Frischknecht

We brought Lagom Consulting on board to help us navigate international compliance for our Class 1 medical products. The level of detail was thorough and gave us the peace of mind we needed in what can be a complex process.

Cubits · Joe

Siamo molto soddisfatti del lavoro che stiamo svolgendo con Riccardo ed Omar, persone professionalmente molto preparate che offrono sempre con puntualità e precisione supporto al cliente.

Charlie Max Milano · Davide Da Rold

Ci hanno supportato in modo impeccabile nella predisposizione dei fascicoli tecnici e nella gestione della documentazione, offrendo un grande aiuto in tutte le fasi.

Res Rei · Oliviero Zanon

Competenti, efficaci, rapidi e sempre disponibili, Riccardo e Omar rappresentano una vera risorsa alla risoluzione delle criticità, oltre ad aver dimostrato di essere preziosi nella collaborazione alla creazione di nuove linee, nuovi prodotti.

Fitobucaneve · Monica Nerci

Veniamo tempestivamente aggiornati sulle nuove normative o su cambiamenti riguardo ad esse. Il servizio è efficiente e chiaro, ed il team è sempre gentilissimo.

Danshari · Giuseppe La Boria

Abbiamo iniziato una collaborazione proficua, molto formativa ma soprattutto che ha portato un valore aggiunto tangibile alla nostra azienda.

Bestmad · Alberto Lacagnina

Riccardo Piazza è un esempio di assoluta professionalità, competenza e capacità di analisi dei problemi aziendali. Con la sua preparazione infonde fiducia e sicurezza su tematiche complesse.

4Planets · Andrea Fabbri

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Testimonials are shown in the language they were written in.

Manufacturers outside the EU

Your partner for worry-free selling in Europe

Is your company's registered office in China, Korea, Japan, the United States, the UK or Switzerland? The Regulation requires a partner established in the European Union who answers for you to the authorities. Here is what you need and what we do.

  1. The EU Authorised Representative (EC REP)

    We represent you before the European authorities under a written mandate: our name will appear on the product label with the EC REP symbol.

  2. Technical documentation

    We write or review your technical file, risk analysis, EU declaration of conformity, labels, instructions and everything else required by Regulation (EU) 2017/745 or 2016/425.

  3. All-round support to stay compliant

    Post-market surveillance, dealings with importers and authorities, regulatory updates, annual audit: we stay with you after your first entry into the market.

Why Lagom

  • Eyewear specialists since 2012: frames, readers, sunglasses.
  • Representative and consultants in the same firm: your file is checked by people who know it well.
  • One service: EC REP, PRRC, labelling, EUDAMED and everything else you need.
  • Over 60 companies from 8 countries already trust us with their products.
Let's talk

Your case

United Kingdom

Since 1 January 2021 the UK has been a third country for the EU: a British manufacturer needs an EU Authorised Representative like anyone else outside the Union.
If you are a European manufacturer, we support you with the documentation you need to sell in the UK (UKCA).

Your case

Switzerland

Switzerland is a third country too: a Swiss manufacturer needs an EU Authorised Representative to sell in Europe.
And if you are a European manufacturer, we support you with the documentation you need to sell in Switzerland.

About us

Lagom: just right

In Swedish, lagom means “not too much, not too little”. That is how we work: only what you need, done well and with no needless complications.
And above all, taking the documentation off your mind.

Questions

What people ask us most often

I have my own eyewear brand but another company manufactures my glasses. What do I need to do?

Under the Regulation, the manufacturer is you: whoever places eyewear on the market under their own name or brand counts as the manufacturer, even if another company makes it. Technical file, EU declaration of conformity, CE marking, PRRC, EUDAMED registration and post-market surveillance are therefore your responsibility. The company that makes your eyewear becomes your supplier and must give you access to documents and checks. If your company is based outside the EU you also need an Authorised Representative. We take care of putting everything in order.

Are spectacles with demo lenses medical devices?

Yes: the Regulation defines them as an “accessory” to medical devices, and the Regulation applies to both devices and their accessories.

What about prescription sunglasses?

They are both a medical device and PPE: both regulations apply and the documentation must meet both.

Do I need a notified body?

No, conventional spectacles and sunglasses do not need the approval of a notified body. You still need a complete technical file, ready for inspection.

What is the difference between an authorised representative and an importer?

The authorised representative acts on behalf of the non-EU manufacturer towards the authorities, under a written mandate. The importer places the product on the EU market and checks that it complies. They are two different roles, with different obligations.

What is a PRRC?

The Person Responsible for Regulatory Compliance required by Article 15 of Regulation (EU) 2017/745. Micro and small enterprises can rely on an external consultant, as long as one is permanently and continuously at their disposal: it is one of the services we offer.

I am a Swiss or British manufacturer: what changes?

For the EU you count as a non-EU manufacturer: for medical devices you need an Authorised Representative established in the European Union, with its name on the label.