Europe’s EMA
Medical Devices
Health Authority:
Medical devices are products or equipment intended generally for a medical use. They are regulated by national competent authorities of the European Union (EU). Depending on the medical device category sometimes the European Medicines Agency (EMA) can also be involved in their assessment.
Medical Device Regulations:
Medical devices within the EU are currently regulated by 3 directives; the Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990), the Council Directive 93/42/EEC on Medical Devices (MDD) (1993), and the Council Directive 98/79/EC on in vitro Diagnostic Medical Devices (IVDMD) (1998).
Medical Device Registration Pathway:
Medical devices in the EU must undergo a conformity assessment to demonstrate that they meet legal requirements to ensure they are safe and perform as intended. EU Member States can designate accredited notified bodies to conduct conformity assessments. The conformity assessment usually involves an audit of the manufacturer’s quality system and, depending on the type of device, a review of technical documentation from the manufacturer on the safety and performance of the device.
More Resources:
- European Medicine Agency.
- To access more information click the ‘Read More‘ Tab.
Important change of Regulation Notice:
In May of 2017, the adoption of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic Devices (IVDR) changed the European legal framework for medical devices, introducing new responsibilities for EMA (European Medical Device Agency) and for national competent authorities.
During the transition period, manufacturers can place devices on the market under the currently applicable EU Directives (93/42/EEC, 98/79/EC and 90/385/EEC) or under the new Regulations if they fully comply with these.
Due to Covid-19 the EU has decided to delay the medical devices and IVDs transitional period.
- MDR’s have a transition period has been extended due to Covid-19 and will fully apply from 26 May 2021.
- The IVDR has a transition period of five years and will be extended from May 2023.
Pharmaceuticals
Pharmaceutical Definition:
A drug, or medicinal product in the EU, is defined “as any substance or combination of substances presented for treating or preventing disease in human beings or animals“.
Pharmaceutical Registration Pathways:
When a company wants to authorize a medicine in one or more Member States, they can use one of the following procedures:
•Decentralized– procedure where companies can apply for the simultaneous authorization of a medicine in more than one EU Member State if it has not yet been authorized in any EU country and does not fall within the scope of the centralized procedure.
• Mutual-recognition -procedure where companies that have a medicine authorized in one EU Member States can apply for this authorization to be recognized in other EU countries. This process allows Member States to rely on each other’s scientific assessments. Rules and requirements applicable to pharmaceuticals in the EU are the same, irrespective of the authorization route for a medicine.
Free Movement of Goods
It is important to note that the medicinal products in Europe are covered under a free movement of goods. The adoption of the Council Directive of 65/65/EEC on January 26, 1965, the product could be placed onto the market after the marketing authorization was granted.
More Resources:
- To access more information click the ‘Read More‘ Tab.
Cosmetics
Cosmetic Regulations:
The EU harmonized all cosmetic regulation in 2013 under Cosmetics Products Regulation (1223/2009). The harmonization process ensured all products that meet the requirements of the Regulation should have equal and immediate access to the market and should be able to circulate freely throughout the European Union.
Responsible Person:
The key principle of the Cosmetics Regulation is that the person or company who places the cosmetic product on the market, usually the importer or manufacturer, who is responsible for that product (so called ‘Responsible Person’). The Responsible Person must ensure that the product is safe and meets all the requirements of the Cosmetics Regulation. All stages of the development of the cosmetics product is regulated by the Cosmetics Regulation, from the choice of ingredients, labeling, Good manufacturing practice (GMP) to marketing and Cosmetovigilance.
More Resources:
- To access more information click the ‘Read More‘ Tab.
Nutraceuticals
Food Supplement Regulations:
In the European Union (EU), Food supplements are regulated under the European Food and Safety Authority (EFSA).The main EU legislation is Directive 2002/46/EC related to food supplements.
Food Supplement Definition:
The EU defines “food supplements” as “concentrated sources of nutrients (e.g., proteins, vitamins and minerals) and other substances that have a beneficial nutritional effect.“
The EU maintains a list of permitted vitamin or mineral substances which may be added to food supplements for specific nutritional purposes. Vitamin and mineral substances may be considered for inclusion in the lists following the evaluation of an appropriate scientific dossier concerning the safety and bioavailability of the individual substance by EFSA.
Strict EU Criteria:
The European Union has a reputation of enforcing strict rules for product claims and difficult approval process. Companies wishing to market a substance not included in the permitted list need to submit an application to the European Commission. New products originating from Europe are presumed to have passed these stricter European development and quality requirements.
GRP Services:
Global Regulatory Partners, Inc. (GRP), has a team of experts in Europe who can help Nutraceutical and food supplements companies in Europe during their products’ development. The team reviews the list of ingredients to make sure that they are safe for consumers and are within the daily dose limits allowed by local regulations. The team also reviews and validate the content of the products labeling and packaging and makes sure that nutrient content claims and health claims made by the manufacturer are validated and supported by scientific data before any products’ commercialization.
More Resources:
- To access more information click the ‘Read More‘ Tab.